Journal of pain & palliative care pharmacotherapy
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J Pain Palliat Care Pharmacother · Dec 2010
ReviewLegal liability perspectives on abuse-deterrent opioids in the treatment of chronic pain.
Abuse-deterrent opioid analgesic formulations can help reduce the risk of opioid diversion and abuse. Not all opioid analgesics are available as both extended- and immediate-release dosage forms in abuse-deterrent formulations. ⋯ There is the possibility that a health care professional may be held legally liable when a product without abuse-deterrent qualities is used and a person suffers harm that would not have occurred had an abuse-deterrent formulation been provided. This article reviews legal precedents that inform an understanding of the need to reduce malpractice exposure by identifying patients who are at high risk of opioid diversion and/or abuse and considering the use of an abuse-deterrent formulation for these patients.
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J Pain Palliat Care Pharmacother · Sep 2010
ReviewResearch in end-of-life settings: an ethical inquiry.
A fundamental tension surrounds the ethics of conducting research in vulnerable populations, and specifically, research involving patients at or near the end-of-life. In Palliative Medicine, these patients' care has historically been based on compassion, clinical judgment and experience, and anecdote rather than on data generated through high-quality clinical trials. A robust evidence base to support clinical practice in the end-of-life setting is lacking. ⋯ Arguments can be categorized into claims that the goals of research conflict with the goals of care; research unduly burdens vulnerable patients and families/caregivers; genuine equipoise does not exist; and research in the palliative care setting is too difficult. The authors explore and respond to these objections, noting the vital importance of research at this stage of the illness trajectory. The authors conclude that barriers to palliative care research are surmountable, and, indeed, that the "research imperative" and principles laid out in the Belmont Report of 1979 require us to rigorously study clinical interventions used for palliative care patients-so as to provide optimal safety and outcomes for present and future patients.
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The literature on the impact of opioid pharmacotherapy on driving ability and safety is reviewed. Recommendations for safe driving while taking opioids and limitations of the data are discussed.
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J Pain Palliat Care Pharmacother · Jan 2009
ReviewMedical marijuana: the conflict between scientific evidence and political ideology. Part two of two.
In Part I of this article, I examined the role of the Food and Drug Administration (FDA) in drug approval and then detailed the known risks of medical marijuana (any form of Cannabis sativa used--usually by smoking--to treat a wide variety of pathologic states and diseases). Part II of the article will begin by reviewing the benefits of Cannabis sativa as documented by well designed scientific studies that have been published in the peer-reviewed literature. ⋯ I will conclude that political advocacy is a poor substitute for dispassionate analysis and that neither popular votes nor congressional "findings" should be permitted to trump scientific evidence in deciding whether or not marijuana is an appropriate pharmaceutical agent to use in modern medical practice. Whether or not marijuana is accepted as a legitimate medical therapy should remain in the hands of the usual drug-approval process and that the statutory role of the Food and Drug Administration should be dispositive.
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J Pain Palliat Care Pharmacother · Jan 2009
ReviewMedical marijuana: the conflict between scientific evidence and political ideology. Part one of two.
Whether "medical marijuana" (Cannabis sativa used to treat a wide variety of pathologic states) should be accorded the status of a legitimate pharmaceutical agent has long been a contentious issue. Is it a truly effective drug that is arbitrarily stigmatized by many and criminalized by the federal government? Or is it without any medical utility, its advocates hiding behind a screen of misplaced (or deliberately misleading) compassion for the ill? Should Congress repeal its declaration that smoked marijuana is without "current medical benefit"? Should cannabis be approved for medical use by a vote of the people as already has been done in 13 states? Or should medical marijuana be scientifically evaluated for safety and efficacy as any other new investigational drug? How do the competing--and sometimes antagonistic--roles of science, politics and prejudice affect society's attempts to answer this question? This article examines the legal, political, policy, and ethical problems raised by the recognition of medical marijuana by over one-fourth of our states although its use remains illegal under federal law. ⋯ Instead, the specific focus of this article will be on the conflict between the development of policies based on evidence obtained through the use of scientific methods and those grounded on ideological and political considerations that have repeatedly entered the longstanding debate regarding the legal status of medical marijuana. I will address a basic question: Should the approval of medical marijuana be governed by the same statute that applies to all other drugs or pharmaceutical agents, the Food, Drug, and Cosmetic Act (FD&C Act), after the appropriate regulatory agency, the Food and Drug Administration (FDA), has evaluated its safety and efficacy? If not, should medical marijuana be exempted from scientific review and, instead, be evaluated by the Congress, state legislatures, or popular vote? I will argue that advocacy is a poor substitute for dispassionate analysis, and that popular votes should not be allowed to trump scientific evidence in deciding whether or not marijuana is an appropriate pharmaceutical agent to use in modern medical practice.