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. (shrink)

Two significant, apparently unrelated, trends have emerged in American society and medicine. First, American medicine is reexamining its approach to dying. The Institute of Medicine, the American Medical Association and private funding organizations have recognized that too many dying people suffer from pain and other distress that clinicians can prevent or relieve. Second, this past decade has marked a sharp increase in the number of physicians prosecuted for criminal negligence based on arguably negligent patient care. The case often cited as (...) a watershed is People u. Einaugfer, which involved a New York nursing home patient whose physician was convicted in 1993 of two criminal misdemeanors after he ordered an elderly dialysis patient to be tube fed through a peritoneal dialysis Catheter.How is the growing awareness of dying patients’ pain and the increasing willingness of prosecutors to charge physicians with crimes connected? Pain at the end of life is frequently treated with narcotics, prescription drugs that are closely regulated by state and federal law. That complex web of laws—and a growing fear of legal sanctions—has deterred physicians from prescribing controlled substances. As those legal sanctions move from disciplinary actions to criminal charges, physicians’ fears may expand. (shrink)

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. (shrink)

Two significant, apparently unrelated, trends have emerged in American society and medicine. First, American medicine is reexamining its approach to dying. The Institute of Medicine, the American Medical Association and private funding organizations have recognized that too many dying people suffer from pain and other distress that clinicians can prevent or relieve. Second, this past decade has marked a sharp increase in the number of physicians prosecuted for criminal negligence based on arguably negligent patient care. The case often cited as (...) a watershed is People u. Einaugfer, which involved a New York nursing home patient whose physician was convicted in 1993 of two criminal misdemeanors after he ordered an elderly dialysis patient to be tube fed through a peritoneal dialysis Catheter.How is the growing awareness of dying patients’ pain and the increasing willingness of prosecutors to charge physicians with crimes connected? Pain at the end of life is frequently treated with narcotics, prescription drugs that are closely regulated by state and federal law. That complex web of laws—and a growing fear of legal sanctions—has deterred physicians from prescribing controlled substances. As those legal sanctions move from disciplinary actions to criminal charges, physicians’ fears may expand. (shrink)

As medical technology becomes more sophisticate the ability to manipulate nature and manage disease forces the dilemma of when can becomes ought. Indeed, most bioethical discourse is framed in terms of balancing the values and interests and the benefits and burdens that inform principled decisions about how, when, and whether interventions should occur. Yet, despite advances in science and technology, one caregiver mandate remains as constant and compelling as it was for the earliest shaman—the relief of pain. Even when cure (...) is impossible, the physician's duty of care includes palliation. Moreover, the centrality of this obligation is both unquestioned and universal, transcending time and cultural boundaries.Although universally acknowledged, pain is a complex phenomenon for both the patient and the caregiver, influenced as much by personal values and cultural traditions as by physiological injury and disease. (shrink)

During the past decade, debate has intensified about the role of long-term opioid therapy in the management of chronic nonmalignant pain. Specialists in pain management have discussed the issues extensively and now generally agree that a selected population of patients with chronic pain can attain sustained analgesia without significant adverse consequences. This perspective, however, is not uniformly accepted by pain specialists and has not been widely disseminated to other disciplines or the public. Rather, the more traditional perspective, which ascribes both (...) transitory benefit and substantial cumulative risk to long-term opioid therapy, continues to predominate. According to this perspective, the inevitability of tolerance limits the possibility of sustained efficacy, and other pharmacological properties increase the likelihood of adverse outcomes, including persistent side-effects, impairment in physical and psychosocial functioning, and addiction. If accurate, these outcomes would indeed justify the withholding of opioid therapy for all but the most extreme cases of chronic nonmalignant pain. (shrink)

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. (shrink)

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. (shrink)

During the past decade, debate has intensified about the role of long-term opioid therapy in the management of chronic nonmalignant pain. Specialists in pain management have discussed the issues extensively and now generally agree that a selected population of patients with chronic pain can attain sustained analgesia without significant adverse consequences. This perspective, however, is not uniformly accepted by pain specialists and has not been widely disseminated to other disciplines or the public. Rather, the more traditional perspective, which ascribes both (...) transitory benefit and substantial cumulative risk to long-term opioid therapy, continues to predominate. According to this perspective, the inevitability of tolerance limits the possibility of sustained efficacy, and other pharmacological properties increase the likelihood of adverse outcomes, including persistent side-effects, impairment in physical and psychosocial functioning, and addiction. If accurate, these outcomes would indeed justify the withholding of opioid therapy for all but the most extreme cases of chronic nonmalignant pain. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and to (...) pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and to (...) pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

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. (shrink)

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 and, second, the scheduling decisions made by the Drug Enforcement Administration. 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 and began marketing it as an analgesic. (shrink)

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 and, second, the scheduling decisions made by the Drug Enforcement Administration. 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 and began marketing it as an analgesic. (shrink)

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 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. (shrink)

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 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. (shrink)

The problem is pain. Patients and their families tell the story:He is your son. You love him. You want to help him in every way you can, but when he is in that kind of pain, you are helpless in a sense. Im his daddy. It was-what was I supposed to do for him? I felt, you know, helpless.It terrifies you. You want to run away from it. Pain is something you wish would kill you but does not. Agony results (...) from the pain that does not have the decency to knock you out.[W]e had a good family, but how much can you watch? How much suffering can you watch from your child, your 7-year-old child, and still keep your mind?I am a forty-six-year-old registered nurse who specializes in oncology care and education. I am also a patient who suffers from chronic nonmalignant pain, and this malady has been the most frightening, the most humiliating, and the most difficult ordeal of my life. (shrink)

The problem is pain. Patients and their families tell the story:He is your son. You love him. You want to help him in every way you can, but when he is in that kind of pain, you are helpless in a sense. Im his daddy. It was-what was I supposed to do for him? I felt, you know, helpless.It terrifies you. You want to run away from it. Pain is something you wish would kill you but does not. Agony results (...) from the pain that does not have the decency to knock you out.[W]e had a good family, but how much can you watch? How much suffering can you watch from your child, your 7-year-old child, and still keep your mind?I am a forty-six-year-old registered nurse who specializes in oncology care and education. I am also a patient who suffers from chronic nonmalignant pain, and this malady has been the most frightening, the most humiliating, and the most difficult ordeal of my life. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)