State medical boards are beginning to take a more balanced approach to monitoring and disciplining for prescribing of pain medications, according to this survey of state medical boards across the country. Overall, respondents indicated that they are becoming more educated and more sophisticated in their approach to complaints of opioid overprescribing. In addition, their responses reflect a heightened awareness of the appropriateness of treating chronic pain with controlled substances.

Yet, despite these inroads, boards generally demonstrate a continued tolerance of pain undertreatment, the survey found. There is a discrepancy in the weight given to violation of standard of care, patient harm, and gross negligence for opioid overprescribing versus undertreatment of pain. Boards appear to have a higher threshold for patient harm in cases involving pain undertreatment — particularly for chronic nonmalignant pain.

Diversion of controlled substances from medical to nonmedical purposes is a significant public health problem. However, there is great fear that regulatory efforts to curb this activity could have a chilling effect on appropriate and necessary pain management.

To track the extent to which there is inappropriate prescribing and dispensing of controlled substances, seventeen states have adopted prescription monitoring programs. Although earlier programs relied on ink-on-paper multiple copy or serialized prescriptions, the recent trend has been the development of electronic-based programs that can link to computerized pharmacy systems. Although these programs have not been thoroughly analyzed for their safety or efficacy, there is growing enthusiasm for them. The Drug Enforcement Administration (DEA) backs the development of state-based electronic prescription monitoring programs and a bill is pending in Congress that would create a national program.

Both the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) play a role in regulating pain management technologies, including pharmaceutical products and medical devices indicated for analgesic use. Yet, as things stand, these two key federal entities, with their distinctly different missions and cultures, contribute to the persistent undertreatment of pain through both overregulation and duplicative regulation. The solution lies in refining pain regulation so that a better balance is created between the need to ensure patient access to pain relief and the need to prevent and reduce drug diversion.

Various federal regulatory mechanisms — such as limits on supplies and distribution channels — have created barriers that ultimately affect access to pain management technologies for legitimate users. As the FDA and DEA focus their attention on the misuse of legitimate pain technologies, patients ultimately may be deprived of valuable analgesic agents.

A recurring theme in the debate over adequate pain management is the extent to which physicians’ fear of criminal investigation and prosecution has set up barriers to appropriate dispensing of pain relief to patients. While there have been several studies looking at the regulatory environment and its effect on physicians’ prescribing practices and the treatment of pain, there has been scant research on the probability of investigation or prosecution of physicians who aggressively prescribe opioids for pain management.

To understand whether physicians’ fear of investigation or prosecution is based on a realistic assessment of risk, the authors surveyed chief prosecutors in four states (Maryland, Connecticut, Oregon, and Washington), all of which have varying degrees of focus, prosecutorial culture, and regulatory attitudes toward this issue.

Nurses are on the front lines of pain management, yet in Alabama and eleven other states they are not legally authorized to prescribe any controlled pain medications. In this survey of certified registered nurse practitioners in Alabama, 83 percent of the nurses responding to a question about the connection between prescriptive authority and pain management said that the lack of prescriptive authority for controlled substances delays pain management treatment, and 88 percent of those proffering an opinion about the importance of prescriptive authority said that expanding their prescriptive authority to include those medications would improve patient outcomes.

At the same time, however, many nurses indicated that they are not adequately prepared to prescribe and manage pain medications. Fifty-five percent of the nurses responding to a question about whether they were prepared to make decisions when working under protocols related to controlled substances answered no. And 44 percent of the respondents to a question about the nurse practitioner educational curricula said that they did not feel their education had adequately prepared them for prescribing controlled pain medications.

Scholarship has intrinsic value, of course; but when good scholarship can stimulate change for the better in an area as fundamental to human dignity as health care and the relief of suffering, there is a special satisfaction. This has been our experience since 1996, when the first of now four special issues of this journal focused on legal, regulatory, ethical, professional, and financial issues in medical treatment for pain.

With the generous and steadfast support of the Mayday Fund, the American Society of Law, Medicine & Ethics (ASLME) has generated a significant body of scholarship published in the Journal of Law, Medicine & Ethics (JLME). This research has proven absolutely essential in changing public policy to support better care for those who suffer pain.

Over these years, the Mayday Project at ASLME has tackled many of the real and perceived barriers to effective pain relief. In pain management, both real and perceived obstacles can have a powerful negative effect.

Uncertainty regarding potential disciplinary action may give physicians pause when considering whether to accept a chronic pain patient or how to treat a patient who may require long-term or high doses of opioids. Surveys have shown that physicians fear potential disciplinary acrion for prescribing controlled substances and that physicians will, in some cases, inadequately prescribe opioids due to fear of regulatory scrutiny. Prescribing opioids for long-term pain management, particularly noncancer pain management, has been controversial; and boards have investigated and, in some cases, disciplined physicians for such prescribing. While in virtually all of these cases the disciplinary actions were successfully appealed, news of the success was not often as well-publicized as news of the disciplinary actions, leaving some physicians confused about their potential liability when prescribing opioids for pain. The confusion has perhaps increased as a result of two relatively recent cases, one where a physician was successfully disciplined by a state medical board for undertreatment of his patients’ pain, and another where the physician was successfully sued for inadequate pain treatment.

There is general agreement that the “principle of balance” should guide controlled substance policy and regulation in the United States. Although the diversion of controlled substances from medical to nonmedical purposes is a significant public health problem, overly aggressive controlled substance regulation has been shown to have an unintended deterrent effect on appropriate controlled substance use, including pain management with opioid analgesics. The promotion of effective pain management and the reduction of substance abuse are equally important regulatory objectives. Neither regulatory objective need be sacrificed to achieve the other. Rather, the two objectives must be balanced with each other to assure that necessary pain management is encouraged while drug abuse is curtailed.

Approximately 75 million people in the United States suffer from severe pain. Fifty million of these suffer chronic pain, and 25 million suffer acute pain from trauma or surgery. Pain is not merely an uncomfortable symptom.

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). If a “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.

The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic.

The experience of having to suffer debilitating pain is far too common in the United States, and many patients continue to be inadequately treated by their doctors. Although many physicians freely admit that their pain management practices may have been somewhat lacking, many more express concern that the prescribing of heightened levels of opioid analgesics may result in closer regulatory scrutiny, criminal investigation, or even criminal prosecution.

Although several researchers have examined the regulatory environment and the threat of sanction or harm it poses to physicians and patients, few have examined the likelihood of investigation or prosecution stemming from the aggressive use of opioids in physician-directed pain management. Accordingly, in an effort to assess whether the fear of prosecution is realistic and, if so, what factors contribute to its likelihood, we surveyed chief prosecutors in four states about their knowledge, opinions, and attitudes concerning opioids and the prosecution of physicians stemming from the treatment of patients who were either terminally ill or suffering from chronic noncancer pain.

The Mayday Scholars Program for 2001-2002 provided an opportunity to boards of nursing to present their experiences in monitoring the prescribing practices of advanced practice nurses and to research ways for improving their own investigation processes as professional disciplinary agencies for prescribing practices related to pain management. The Alabama Board of Nursing was interested in participating in the program based on its commitment to accountability for public protection. A gradual increase in disciplinary cases involving violations of prescribing practices by certified registered nurse practitioners (CRNPs) prompted our inquiry as to whether a proactive monitoring system was needed to determine compliance with regulations for advanced practice nurses in collaborative practice.

In this article, we discuss selected elements related to pain management and regulatory factors, including nursing, that affect the treatment of pain. We present a brief overview of the evolution of advanced practice nursing, with an emphasis on the nurse practitioners movement, and prescription practices and pain management by nurse practitioners.

Despite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems account for the gap between what is known about pain management and what is practiced. Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing.

State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny.

Since the Supreme Court of New Jersey decided the Quinlan case a quarter of a century ago, three American Supreme Court decisions and a host of state appellate decisions have addressed end-of-life issues. These decisions, as well as legislation addressing the same issues, have prompted a torrent of law journal articles analyzing every aspect of end-of-life law. In recent years, moreover, a number of law review articles, many published in this journal, have also specifically addressed legal issues raised by palliative care. Much less is known in the United States, however, as to how other countries address these issues. Reflection on the experience and analysis of other nations may give Americans a better understanding of their own experience, as well as suggest improvements to their present way of dealing with the difficult problems in this area.

This article offers a conceptual and comparative analysis of major legal issues relating to end-of-life treatment and to the treatment of pain in a number of countries. In particular, it focuses on the law of Australia, Canada, the United Kingdom, Poland, France, the Netherlands, Germany, and Japan.

The word “epidemic” seems inadequate to describe the spread of the HIV virus in sub-Saharan Africa. The latest estimates suggest that 28.5 million people in this region are infected, including 5 million in South Africa alone. The HIV and AIDS pandemic, with infection rates of over 20 percent in seven African countries, rivals the worst of history's disease outbreaks, including the bubonic plague of medieval times. The devastating effects of the disease on the continent are compounded by extreme poverty in the region and the lack of medical infrastructure essential for delivering the full range of available treatments for HIV infection, AIDS, and the opportunistic infections associated with the disease. Of the 40 million people infected with HIV worldwide, only 730,000 receive combination antiretroviral therapies. In the entire African continent, only 30,000 infected people currently receive such forms of treatment.

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

Dr. James Graves was convicted of manslaughter, racketeering, and drug charges in association with overdose deaths of four of his patients from the painkiller OxyContin. A Florida court then sentenced the physician to 62.9 years in prison. This is the first criminal conviction of a doctor in the United States related to OxyContin deaths.

Dr. Graves, who ran a pain management office, was charged with recklessly writing prescriptions to those that could afford an office visit and failed to ask appropriate questions beforehand. Prosecutors in the case said that the physician prescribed drugs like OxyContin to as many as ninety patients a day, after only a short office visit. The prosecution claimed that Graves was “‘selling prescriptions for cash without any real examination, diagnostic testing, or follow-up, no consultation, no real assessment of their medical needs.’”

Effective November 1, 2002, the federal Department of Health and Human Services (DHHS) reclassified developing fetuses as “unborn children,” thereby providing health insurance benefits for prenatal care under the State Children's Health Insurance Program (SCHIP). By broadening the current definition of “child” —and thus expanding SCHIP insurance coverage — DHHS hopes to increase the number of low-income pregnant women who receive prenatal services. As noted by one commentator, the new rule represents the first time “any federal policy has defined childhood as beginning at conception.”

In an attempt to improve access to publicly funded health insurance for poor children not covered by Medicaid, Congress established SCHIP a 10-year, $40 billion program jointly funded by federal and state governments. Through a series of block grants, SCHIP allows states to either expand income-eligibility for their existing Medicaid program or to create a separate child health program to decrease the number of uninsured poor and near-poor children.

On September 25, 2002, California Governor Gray Davis approved the Health Care Providers’ Bill of Rights (A.B. 2907). The legislation, which went into effect January 1, 2003, outlaws several practices by insurers that physicians complained represented an imbalance of power. Insurers are now unable to compel doctors to take more patients than they feel they can handle, and managed care companies cannot unilaterally change the terms of their contracts with doctors without notice. Governor Davis praised the legislation, stating, “in order to provide patients with world-class care, we must ensure that our doctors have world-class rights.”

California has one of the highest levels of health maintenance organization (HMO) penetration in the nation, at 52 percent. Seventy-eight percent of HMO patients are enrolled in five HMOs. As a result of these practice conditions, doctors reportedly often felt pressured to comply when HMOs “ordered [them] to take on additional patients,” “changed contracts without warning,” and were “lax in payments.”