Publications
APS Bulletin • Volume 15, Number 4, Fall 2005
Pain and the Law
Overcoming Legal Barriers to Competent and Compassionate Pain Relief for Patients with Chronic Nonmalignant Pain
Ben A. Rich, JD PhD
A previous article that appeared in the Pain and the Law section of the Bulletin considered legal barriers to the treatment of pain at the end of life, focusing on criminal actions against physicians who prescribed opioids for dying patients. Given that a few healthcare institutions and professionals have been held liable in civil actions for failure to provide sufficient analgesia to dying patients, criminal actions (however few in absolute terms) against physicians who were seeking to ensure that their patients did not suffer lend significant credence to the proposition that in the prescribing of opioids, clinicians are truly between a proverbial “rock and a hard place.”
The circumstances are even more ambiguous in the care of chronic nonmalignant pain patients, for whom concerns about pain management must be balanced by commen-surate goals of improving levels of function, preserving mental acuity, and, in rare cases, recognizing and addressing the risk of addiction. The barriers to effective pain management are therefore most formidable in the domain of chronic nonmalignant pain. This article and future ones in this department of the Bulletin will explore the current status of barriers to the treatment of these patients. The concern here is the role of state medical licensing boards.
Intractable Pain Treatment Acts
There is convincing evidence that in the late 1980s and early 1990s, state medical licensing board practices clearly constituted a regulatory barrier to the provision of pain relief. Despite growing evidence of an epidemic of undertreated pain in the United States, based at least in part on physician ignorance and fear regarding the use of opioid analgesics, medical boards persisted in disciplining physicians for alleged “overprescribing” while at the same time denying that underprescribing was a problem with which they should be concerned or, indeed, a problem with any foundation in fact.
Eventually, the growing frustration with the chilling effect of medical board policy and practice on the care of patients with chronic pain reached the halls of state legislatures, leading to the enactment of so-called “intractable pain” statutes (IPTAs; Joranson, 1995). The primary motivation for and objective of these statutes, which have been adopted by roughly a dozen states, was to send a legislative message to the state medical licensing boards that it was against public policy to take disciplinary action against a physician solely and exclusively because he or she had prescribed opioid analgesics to patients with chronic nonmalignant pain. The thrust of these statutes was to declare, again as a matter of public policy, that such a prescribing practice was not inappropriate per se. It is interesting to note that the Drug Enforcement Administration (DEA), a federal agency ostensibly much more concerned about drug diversion than pain management, included the following provision in its Physician’s Manual:
Controlled substances and, in particular, narcotic analgesics, may be used in the treatment of pain experienced by a patient with a terminal illness or chronic disorder. These drugs have a legitimate clinical use and the physician should not hesitate to prescribe, dispense, or administer them when they are indicated for a legitimate medical purpose. (1990, p. 21)
The goal of IPTAs was to insulate physicians from regulatory liability for their good faith efforts to provide pain relief to this category of patient. Such statutes required that medical boards provide competent and credible evidence that under the particular circumstances of a case, such prescribing was inappropriate or otherwise a contravention of acceptable medical practice, as a condition precedent to disciplinary action.
Although well-intentioned, IPTAs have been problematic, beginning with the term “intractable pain.” Intractable is commonly used to denote a state of affairs or phenomenon that cannot be changed or remediated. Thus, according to that definition, intractable pain is categorically untreatable. However, IPTAs typically define intractable pain as “a pain state in which the cause cannot be removed or otherwise treated, and no relief or cure has been found after reasonable efforts” (Joranson, 1995, p.1). Thus, the cause of the pain is (or should be) the referent of the term intractable, not the resulting pain. To identify a pain state as intractable according to such legislation is to empower the clinician to focus on relieving the pain, which may not be “intractable” in the common usage of the term.
There are other potentially negative implications to the language of the typical IPTA. The prescribing of opioids for such patients is typically characterized as a last resort when all other potential treatment modalities have failed and only when the underlying cause of the pain cannot be identified or effectively treated (Joranson & Gilson, 1997). In so conceptualizing intractable pain, IPTAs actually may undermine rather than facilitate the appropriate use of opioids for moderate to severe chronic nonmalignant pain conditions.
Classic Case in Point: Florida Board of Medicine v. Hoover
At least one state medical board demonstrated open hostility to a legislature’s effort to support an enlightened approach to chronic nonmalignant pain. In 1994, the Florida legislature enacted an IPTA. Nevertheless, the Florida Medical Board initiated disciplinary action against Katherine Hoover, MD, an internist who provided opioid analgesia to a number of chronic pain patients. In its disciplinary action for inappropriate prescribing, the board put forward as experts two physicians who readily acknowledged that they did not treat chronic pain patients in their practices. Moreover, the only records they reviewed regarding Hoover’s care of the patients in question were pharmacy computer printouts. Nevertheless, they offered testimony that in their opinion Hoover had prescribed excessive, potentially “lethal” doses of opioids to these patients (Hoover v. Agency for Health Care Administration [AHCA] , 1996).
Hoover sought to rely, in part, on the recently enacted Florida intractable pain statute. The medical board argued to the hearing officer that the statute was irrelevant to the case because the patient care being challenged took place before the effective date of the statute. She also sought to introduce into evidence the Agency for Health Care Policy and Research (now Agency for Healthcare Research and Quality) clinical practice guidelines for the management of cancer pain. (There were no such guidelines for chronic noncancer pain at that time.) The Florida board objected to their introduction into evidence on the narrow, technical ground that none of the patients in question had cancer, and, hence, those guidelines were irrelevant to the assessment of Hoover’s prescribing practices. The hearing officer nevertheless found in favor of Hoover. However, the medical board was able, under Florida law, to disregard these findings and conclusions and proceeded to impose disciplinary sanctions on her. She appealed, and the Florida Court of Appeals reversed the board’s action in an opinion that was highly critical of the board’s pattern and practice of taking draconian action against physicians based upon “a woefully inadequate quantum of evidence” (Hoover v. AHCA, 1996). Other medical boards have been similarly chastised in the context of physician challenges to disciplinary sanctions for their prescribing practices (In the Matter of DiLeo, 1995).
The Pendulum Begins to Swing
In 1999, the Oregon Board of Medical Examiners became the first to take disciplinary action against a physician for failure to provide necessary and appropriate pain relief (In the Matter of Bilder, 1999). Paul Bilder, MD, was a pulmonary specialist practicing in a small community. Over a period of 5 years the Oregon Board of Medical Examiners (OBME) identified six of Bilder’s patients who had received manifestly inadequate care. The cases fell into two general categories: (a) inadequate pain relief for patients who were actively dying, and (b) failure or refusal to provide adequate palliation during invasive procedures. In the first category, Bilder was found to have
- prescribed only Tylenol to a hospice patient dying of cancer
- refused to prescribe more than 0.25 mg of Roxanol every 4 hours for a hospice patient on the day of his death
- refused to provide any palliative measures for an 82-year-old patient with congestive heart failure who was agitated and gasping for breath.
In the second category, Bilder was found to have
- discontinued sedatives and pain medication for a ventilator-dependent patient and then ordered a paralytic agent but refused to sedate her when she became agitated and extubated herself
- ordered paralytic but not anxiolytic agents for a ventilator-dependent patient with acute respiratory failure
- declined to order pain or anxiety medication during efforts to insert a breathing tube into the nose of a patient with pneumonia, resulting in the need for nursing staff to physically restrain the patient to complete the procedure.
The OBME reached a consent agreement with Bilder that required him to pursue continuing medical education (CME) and psychological counseling, and to submit to practice limitations and monitoring. Nevertheless, 3 years later the OBME initiated further disciplinary proceedings based on additional cases of substandard pain and symptom management.
According to the initial OBME complaint against Bilder, five of the six individuals who were the victims of Bilder’s negligent acts and omissions were patients at the same facility, Mercy Medical Center. Thus one may reasonably infer that the nursing staff at Mercy, and presumably the medical staff as well, knew, or, as the law is wont to impute, in the exercise of due diligence should have known that Bilder had demonstrated, over a period of 5 years, a pattern and practice of substandard pain and symptom management that was subjecting patients at that facility to unnecessary pain and suffering. Yet it was left to the OBME to take the action necessary to deal with the problems created and the risks posed by Bilder’s deficiencies in knowledge, skill, and attitude concerning palliative measures.
California became the second board to discipline a physician for mismanagement of pain in 2003 (In the Matter of Whitney). The case was in stark contrast to an earlier one in which the California Medical Board (CMB) declined to take any disciplinary action against a physician, even when its own expert reviewer found his management of the pain of an elderly cancer patient to have been substandard. The family of the lately deceased patient obtained a civil judgment against the physician for elder abuse (Bergman v. Chin, 1999). Subsequently, the California Assembly enacted legislation mandating that all physicians (excluding radiologists and pathologists) obtain 12 hours of CME on pain management and end-of-life care. In the subsequent case, the patient was an elderly man who had been transferred from an acute care to a skilled nursing facility in the terminal phase of mesothelioma. The physician who was responsible for his medical management saw him only once during the several weeks preceding his death, and prescribed analagesics only in response to complaints by the patient’s daughter that the patient’s pain was out of control. Rather than basing its disciplinary action on a more expansive and comprehensive critique of the physician’s conduct in the care of this patient, the CMB elected to focus on two instances in which the physician prescribed opioid analgesics in a manner that demonstrated knowledge deficits. In the first, the physician, without having ever examined the patient, ordered Roxinol concentrate, “20 mg/cc, 10 mg orally q 6 hours.” In the second instance, he ordered an “oral solution” of MS Contin, “10 mg q 4 hours prn.” When the pain continued to increase, Whitney changed the order to “MS Contin 5 mg every 2 hours prn.” The CMB noted that MS Contin does not come in an oral solution and that in such patients it should be prescribed on a regular schedule and not prn. The CMB charged the physician with “failure to understand the unique properties of Roxinol solution and MS Contin tablets and to prescribe the medications properly.” A consent agreement was entered into between the CMB and the physician requiring continuing professional education on pain management and other related remedial measures (In the Matter of Whitney, 2003).
Strictly speaking, none of the patients of the physicians who were disciplined by Oregon or California suffered from chronic nonmalignant pain. However, the policies and guidelines of Oregon, California, and the Federation of State Medical Boards (FSMB) do not distinguish between these two types of patients insofar as the physician’s duty to provide competent pain management is concerned. The CMB also recently revised and expanded its pain policy in 2003 to more emphatically make the point that appropriate pain management is essential to sound patient care, and physicians who fail to provide it may be at risk for disciplinary action (Medical Board of California, 2003).
Educating and Adjusting Attitudes of State Medical Board Members
These cases are some indication of a gradual change in the prevailing knowledge and attitudes of state medical licensing board members about the responsibility of physicians to treat pain in their patients, and the role of opioids in the treatment of some forms of moderate to severe chronic pain (Joranson, 2002). David Joranson and his colleagues at the University of Wisconsin Pain and Policy Studies Group have conducted multiple surveys of the knowledge and attitudes of medical board members. At the 2005 APS Annual Scientific Meeting, he presented a graphic illustration of the gradual changes that have taken place from 1991 to 2004 (Joranson, 2005). In 1991, only 12% of medical board members surveyed believed that prescribing opioid analgesics for more than a few months to treat patients with chronic noncancer pain was “lawful and generally acceptable medical practice” (Joranson, 1992). By 1997, the number had increased to 33% (Joranson, Gilson, Dahl, & Haddox, 2002). According to a 2004 survey, the number had reached 67% (Joranson, 2005).
At least in part, this transformation in knowledge and attitudes of state medical licensing board members is a product of a concerted effort by advocates of improved pain management to reach out to medical boards and provide continuing medical education. These efforts also contributed to the decision of the FSMB in 1998 to promulgate model pain guidelines and encourage individual state boards to adopt and apply them. It was the spirit, rather than the letter, of the FSMB Model Guidelines for the Use of Controlled Substances for the Treatment of Pain that was of ultimate significance. That spirit was cogently conveyed in the following introductory language:
Twenty-two states have adopted all or significant portions of the FSMB Model Guidelines. In 2004, the FSMB updated the document and changed “guidelines” to “policy” in the title. The lingering question is the extent to which the demonstrable failure of a physician to possess and consistently apply the knowledge and skills necessary to effectively assess and manage pain will be deemed to constitute a basis for medical board disciplinary action (Hoffman, 2003). It is a particularly pressing question in the states that have formally adopted the FSMB Model Guidelines. If those boards have actually been confronted with cases in which such knowledge and skills were manifestly absent, yet no disciplinary action was taken, the implication is that such guidelines are mere rhetoric rather than genuine reform.Principles of quality medical practice dictate that patients have access to appropriate and effective pain relief...all physicians should become knowledgeable about effective methods of pain treatment and are referred to the Agency for Health Care Policy and Research Clinical Practice Guidelines for a sound approach to the management of acute and cancer related pain. (FSMB, 1998, p.1)
Medical boards with pain policies along the lines of the FSMB that have no record of disciplinary action against physicians may not necessarily be disingenuous in their approach to undertreated pain. Complaints by pain patients or their families to licensing boards are still relatively rare compared to the number of complaints alleging so-called “over-prescribing.” Medical board disciplinary actions, for a number of reasons, are complaint-driven. If the board does not receive complaints of inadequate pain and symptom management, it cannot be expected to generate them on its own. The more concerning question arises with regard to the medical boards that have not seen fit to promulgate any policy statements or guidelines specifically addressing pain and symptom management. One can only speculate whether they have consciously and deliberately declined to do so on the grounds that it is unnecessary or inappropriate. However, given the amount of attention and concern that have been generated in the last decade about evolving standards of care for pain management, and the proper role of opioids in the management of chronic nonmalignant pain, clinicians are legitimately entitled to a clear and current articulation of policy on the part of the board that is responsible for reviewing complaints about their practice and that ultimately has the authority to impose sanctions upon them, including temporary or permanent loss of licensure.
References
Bergman v. Chin, No. H205732-1 (Cal. App. Dep’t. Super. Ct. Feb. 16, 1999). Drug Enforcement Administration. (1990). Physician’s Manual. Alexandria, VA: Author.
Federation of State Medical Boards of the United States, Inc. (1998). Model guidelines for the use of controlled substances for the treatment of pain. Dallas, TX: Author.
Federation of State Medical Boards of the United States, Inc. (2004). Model policy for the use of controlled substances for the treatment of pain. Dallas, TX: Author.
Hoffman, D. E., & Tarzian, A. J. (2003). Achieving the right balance in oversight of physician opioid prescribing for pain: The role of state medical boards. Journal of Law, Medicine, & Ethics, 31, 21-40.
Hoover v. Agency for Health Care Administration, 676 So. 2d 1380 (Dist. Ct. App. 1996). In re DiLeo, MD, 661 So. 2d 162 (La. App. Ct. 1995).
In the Matter of Paul A. Bilder, MD. (1999). Complaint and Notice of Disciplinary Action. Oregon Board of Medical Examiners.
In the Matter of Eugene B. Whitney, MD (2003). Accusation and Stipulated Decision. Medical Board of California.
Joranson, D. E. (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, 12-49.
Joranson, D. E. (1995). State medical board guidelines for the treatment of intractable pain. APS Bulletin, 5, 1-5.
Joranson, D. E., & Gilson, A. M. (1997). State intractable pain policy: Current status. APS Bulletin, 7, 7-9.
Joranson, D. E., Gilson, A. M., Dahl, J. L., & Haddox, J. D. (2002). Pain management, controlled substances, and state medical board policy: A decade of change. Journal of Pain & Symptom Management, 23, 138-147.
Joranson, D. E. (March/April, 2005). 3rd Annual Decade of Pain Control and Research Special Lecture—Pain Management and Public Awareness, APS 24th Annual Scientific Meeting, Boston, MA.
Medical Board of California.(2003). Guidelines for prescribing controlled substances for pain. Sacramento, CA: Author.