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)

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)

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)

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)

The problem of inadequate pain management for both terminally ill patients and patients with chronic pain has recently been documented by a number of authors and studies. A 1997 report by the Institute of Medicine, for example, states that “a significant proportion of dying patients and patients with advanced disease experience serious pain, despite the availability of effective pharmacological and other options for relieving most pain.” There are particularly impressive data that pain associated with cancer is not adequately treated.The problem (...) has been attributed to inadequate education of physicians on approaches to pain management and an often misguided belief that prolonged therapy with certain pain medication will lead to addiction; legal obstacles, such as physicians’ fear of criminal prosecution and other disciplinary actions by state licensing boards for overprescribing narcotics; and inadequate insurance coverage as a result of narrow eligibility criteria for hospice care for Medicare beneficiaries, and inadequate reimbursement more generally for pain management and palliative care. (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 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 (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)

Pain is undertreated in the American health-care system at all levels: physician offices, hospitals, long-term care facilities. The result is needless suffering for patients, complications that cause further injury or death, and added costs in treatment overall. The health-care system's failure to respond to patient pain needs corrective action. Excuses for such shortcomings are simply not acceptable any longer.Physicians have long been accused of poor pain management for their patient. The term “opiophobia” has been coined to describe this remarkable clinical (...) aversion to the proper use of opioids to control pain. If the professional mandate of the health-care professional is to relieve suffering, then physicians are falling far short of their obligations by accepting myths about the use of opioids in the face of evidence to the contrary. (shrink)