Fear of regulatory scrutiny of opioidprescribing practices

There is an ongoing debate between the regulators and the regulated about the extent to which the regulations, and/or the manner of their enforcement, do or should have a chilling effect upon the quality of pain relief provided by healthcare professionals. Physicians in the United States recount horrific tales of armed Drug Enforcement Administration (DEA) agents descending upon physicians' offices in response to a report, often by a local pharmacist, of excessive prescribing practices.40 Similarly, state medical licensing boards have been known to harshly discipline physicians for deviating from the customary practice of underprescribing opioid analgesics, or for prescribing them at all in the care of patients with chronic, nonmalignant pain. Later in this section, we will consider one such case in detail because it illustrates both the attitudes of many licensing board members and the reason why physician fears of regulatory scrutiny and disciplinary action have some foundation in fact.

The DEA is the federal agency primarily responsible for enforcement of the Controlled Substances Act (CSA). It was this legislation, passed by Congress in 1970, that established the five schedules of controlled substances. Schedule II drugs include morphine and other strong opioid analgesics such as fentanyl and oxycodone. The legislative history of the CSA makes it abundantly clear that its purpose was to deter and punish the diversion of controlled substances from legitimate medical purposes and narcotics trafficking, and not to insinuate the federal government or its law enforcement agencies into the legitimate prescribing practices of physicians. In response to charges that the DEA has attempted to become the arbiter of what constitutes the legitimate prescribing of controlled substances, and in doing so intimidating physicians into withholding controlled substances from patients who need them, the DEA notes that its Physicians' manual explicitly acknowledges that opioid analgesics can and should be considered one of the primary means of controlling many types of moderate to severe pain, including chronic nonmalignant pain. Such an official pronouncement, the DEA insists, should provide physicians with all of the reassurance they can legitimately demand that the DEA does not stand between them and proper treatment of their patients' pain problems.

Despite the pervasive view among healthcare professionals in the United States that the policies and practices of the DEA have had a chilling effect on the willingness of professionals to prescribe opioid analgesics for their patients even when clinically indicated, the DEA remains in denial, going so far as to post on its website in October of 2003 a press release entitled "The Myth of the Chilling Effect.'' The thrust of the statement was that "doctors operating within the bounds of accepted medical practice have nothing to fear from the DEA.''41 The purported justification for the "have no fear'' message was that only a small percentage (less than 0.10) of all physicians registered by the DEA were investigated or prosecuted in 2003. What the DEA, and other governmental agencies with jurisdiction over prescription drugs fail to recognize is that "perception is reality,'' for healthcare professionals, as well as the lay public.

A recently published report on the use of opioids in Europe for the management of chronic pain notes, "In every country in Europe prescriptions for strong opioids must be filled in differently from those for other medicines.''38 In quite a few countries, including France, Germany, Italy, Spain, and many in Scandinavia, separate prescription forms must be used for strong opioids. Triplicate forms, an experiment that was undertaken by a number of states in the United States but subsequently abandoned, are required in Austria, Germany, Portugal, Italy, and Switzerland. Studies conducted in the United States revealed that immediately following the adoption of triplicate prescription form requirements for particular types of narcotics, the number of those drugs prescribed in subsequent years decreased substantially. Furthermore, there was an increase in the prescribing of less effective medications that did not require the triplicate form.42 Such data strongly support the proposition that some narcotic diversion control measures do influence physician-prescribing practices in ways that have a negative impact on patient care. Below under The pursuit of balance in drug control law and public policy, we will consider ongoing efforts in the United States, Europe, and elsewhere to modify law and policy so as to provide some measure of balance between the goals of reducing drug diversion and addiction on the one hand, while promoting effective pain and symptom management on the other.

A number of state medical licensing boards, sometimes but not always through the prodding of state legislative initiatives, have begun to issue guidelines or policies with regard to the use of opioid analgesics for the management of chronic pain, especially chronic nonmalignant pain. Rarely do such boards acknowledge that their prior practices in any way justified the undertreatment of pain. Nevertheless, they offer these guidelines as further assurances to physicians that they certainly can no longer point to medical board policies and practices as justification for undertreating pain.43

In the United States, the Federation of State Medical Licensing Boards adopted "Model Guidelines for the Use of Controlled Substances for the Treatment of Pain'' in 1998. The introduction to these model guidelines declared that pain management should be a priority in patient care, and strongly encouraged each state medical licensing board to adopt similar guidelines. Such guidelines accomplish several important goals. First, they make an important public policy statement that licensing boards expect physicians to provide effective pain relief to their patients. Second, they provide general guidelines for the physician to follow in order to document, among other things, that the opioid analgesics prescribed for a particular patient are medically indicated, properly monitored, and demonstrably improve the patient's level of function and/or quality of life. Third, they often incorporate by specific reference the significantly more comprehensive clinical practice guidelines for acute and cancer pain management of the Agency for Health Care Policy and Research. In 2004, the federation issued an expanded document, in the process recharacterizing it as a '"Model policy' to better reflect the practical use of the document.'' From the perspective of pain patients, the document is significantly strengthened by the provision indicating that "inappropriate treatment of pain includes nontreatment, undertreatment, overtreatment, and continued use of ineffective treatments.''44 The precise legal status of such a policy, even when formally adopted by a particular jurisdiction, remains uncertain, particularly with the disclaimer that the policy "is not intended to establish clinical practice guidelines.'' However, it will become increasingly difficult for physicians who depart frequently and materially from the best practices delineated by such policies to justify their approach, especially when the outcome is the unnecessary pain and suffering of their patients. We will consider court cases that may shed further light on the legal implications of substandard pain management practice below under Pain and the courts.

Another question that at this time has not been definitively answered is whether such guidelines will actually be utilized by state medical licensing boards to discipline physicians who deviate from such statements of accepted practice by underprescribing opioid analgesics for their patients with pain. In 1998, the California Medical Board declined to take any disciplinary action against a physician who it found to have provided inadequate pain management to a patient dying of cancer. In 2001, a jury awarded a sizeable judgment to the family of that patient in a lawsuit charging the attending physician with elder abuse.45 This is one of two cases we will consider below under Pain and the courts. In 1999, the Oregon Board of Medical Examiners became the first to actually take disciplinary action against a physician for undertreating the pain of his patients.46

Those who support the Oregon Board do so, at least in part, on the grounds that such actions are the only way to send a clear message to practicing physicians, and indirectly to their patients, that both overprescribing and underprescribing of opioid analgesics constitute unprofessional practice for which there will be genuine accountability. In 2003, the Medical Board of California undertook two measures that strongly suggested a new approach to the subject of pain management. First, it issued updated guidelines on pain management, further emphasizing the significance of pain relief in sound patient care. Second, it initiated disciplinary action against a physician for alleged inadequacies in knowledge related to his treatment of a nursing home patient who was dying of mesothelioma. In a stipulated decision the following year, the physician in question agreed to remedial and punitive measures imposed by the Board.47 In all other jurisdictions at the present time, the message implicit in licensing board conduct is that, while providing appropriate pain relief is commendable, drug diversion and "overprescribing'' will actually place the physician at risk of disciplinary action.

Recent studies reveal that many members of state licensing boards in the USA are ill-equipped by training or experience to evaluate the quality of pain management provided by their licensees.39 Furthermore, some recent disciplinary actions against physicians who used opioid analgesics for patients with severe, chronic nonmalignant pain suggest that medical boards do not even recognize a need to compensate for their lack of expertise by relying on specialists in the field. A case in point is a disciplinary action by the Florida Medical Licensing Board that was reversed by an appellate court.48 Katherine Hoover, a board-certified internal medicine physician, was charged with "inappropriately and excessively'' prescribing Schedule II narcotics to seven chronic pain patients. The agency's case against Dr Hoover consisted of the testimony of two physicians whom it recognized as experts. Neither of the agency's witnesses had examined any portion of the medical records of any of the seven patients in question. Furthermore, neither of the agency's witnesses specialized in the care of patients with chronic pain. In fact, both testified that they referred all such patients to pain management clinics. The sole basis for the opinions which they offered with regard to the appropriateness of Dr Hoover's care of the seven patients was a review of the computer printouts from the pharmacies which had filled the prescriptions written by Dr Hoover. On that basis alone, they opined, and the agency ultimately determined, that Dr Hoover had prescribed amounts of opioid analgesics that were "excessive, perhaps lethal.'' It did not seem to influence the agency's assessment of this testimony that none of these seven patients had suffered any adverse effects from these so-called "lethal doses'' prescribed by Dr Hoover. In deciding to discipline Dr Hoover for her prescribing practices, the board disregarded the findings and conclusions of the hearing officer, who had determined that the evidence submitted by Dr Hoover's experts persuasively demonstrated that her care of the patients under consideration was appropriate.

Dr Hoover appealed the adverse ruling by the Board of Medicine to an appellate court, which held that the board's actions in disregarding the recommendations of the hearing officer were not supported by clear and convincing evidence. Still more disconcerting, however, was the appellate court's references in its written opinion to previous cases in which the board had disregarded the findings and conclusions of hearing officers as to the weight of the evidence, and forged ahead with disciplinary action against the physician for "overprescribing'' Schedule II narcotics. In each of those cases, an appellate court of the State of Florida had chastised the board for taking disciplinary action against a physician on the basis of sparse and inadequate evidence.

What is particularly revealing about the board's missionary zeal in policing the prescribing practices of physicians who treat patients with chronic pain, which the court in Hoover described as "draconian,'' is that they continued unabated despite the fact that the Florida legislature had recently enacted an intractable pain statute specifically intended to encourage physicians to provide state-of-the-art care for such patients. Because the statute was not technically applicable to the Hoover case owing to the chronology of events, the board completely disregarded its policy implications. Such intransigence in the face of a clear public policy mandate does not serve to reassure clinicians that state medical licensing boards have embarked upon a new and more enlightened view of the role of opioid analgesics in the care of patients with chronic pain.

One might be tempted to conclude that the philosophy underlying the regulatory strategies of medical licensing boards appears to be that patients who require large, sustained doses of Schedule II narcotics to manage their pain are better off enduring the pain than relying on opioid analgesics for relief. However, as the approach of the board in the Hoover case demonstrates, the welfare of the patients was not really a genuine concern of the board. If it had been, some attention might have been paid to the patient records, and to patient testimony about the actual outcomes of Dr Hoover's treatment of their chronic pain, rather than exclusively focusing on pharmacy computer printouts. What we find, instead, is an unreflective, essentially reactionary approach to prescribing practices that are tailored to the needs of the patient rather than to some antiquated and scientifically unsubstantiated set of algorithms that has heretofore defined "good medical practice'' with regard to the prescribing of opioid analgesics. Consequently, from an ethical perspective, licensing boards cannot justify their policies by reference to the ancient medical aphorism primum non nocere.

There are additional ethical considerations related to this particular barrier to effective pain management. The typical medical board, after all, is not composed of government bureaucrats or the lay public, but rather of practicing physicians. Presumably, they reflect the knowledge, attitudes, and beliefs of their profession. Indeed, one of the perennial concerns about and critiques of such boards is that they are simply a means by which the profession looks out for itself and perpetuates its own values and agenda. Regardless of whether and to what extent that may be true, it is nonetheless the case that organized medicine has yet to initiate any concerted effort to persuade all professional licensing boards to embrace a more scientifically based and patient-friendly approach to their oversight of physician prescribing practices. Instead, the typical physician has allowed opiophobic attitudes of medical licensing boards to establish and maintain a standard, and indeed an ethic of underprescribing. So long as such a standard and ethic prevail, exceptional physicians like Katherine Hoover, who have the moral courage to take on their board when necessary to the welfare of their patients, must become martyrs to the cause of pain relief for their patients.

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