Pain Management and the Opioid Epidemic PDF Download

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

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Book Description
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Author: Eunjoo Pacifici
Publisher: Academic Press
ISBN: 0128111569
Category : Medical
Languages : en
Pages : 292

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Book Description
Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Author: National Research Council
Publisher: National Academies Press
ISBN: 0309175771
Category : Medical
Languages : en
Pages : 276

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Book Description
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157277
Category : Medical
Languages : en
Pages : 335

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Book Description
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225

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Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442

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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309042860
Category : Medical
Languages : en
Pages : 241

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Book Description
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309065313
Category : Medical
Languages : en
Pages : 216

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Book Description
Some people suffer from chronic, debilitating disorders for which no conventional treatment brings relief. Can marijuana ease their symptoms? Would it be breaking the law to turn to marijuana as a medication? There are few sources of objective, scientifically sound advice for people in this situation. Most books about marijuana and medicine attempt to promote the views of advocates or opponents. To fill the gap between these extremes, authors Alison Mack and Janet Joy have extracted critical findings from a recent Institute of Medicine study on this important issue, interpreting them for a general audience. Marijuana As Medicine? provides patientsâ€"as well as the people who care for themâ€"with a foundation for making decisions about their own health care. This empowering volume examines several key points, including: Whether marijuana can relieve a variety of symptoms, including pain, muscle spasticity, nausea, and appetite loss. The dangers of smoking marijuana, as well as the effects of its active chemical components on the immune system and on psychological health. The potential use of marijuana-based medications on symptoms of AIDS, cancer, multiple sclerosis, and several other specific disorders, in comparison with existing treatments. Marijuana As Medicine? introduces readers to the active compounds in marijuana. These include the principal ingredient in Marinol, a legal medication. The authors also discuss the prospects for developing other drugs derived from marijuana's active ingredients. In addition to providing an up-to-date review of the science behind the medical marijuana debate, Mack and Joy also answer common questions about the legal status of marijuana, explaining the conflict between state and federal law regarding its medical use. Intended primarily as an aid to patients and caregivers, this book objectively presents critical information so that it can be used to make responsible health care decisions. Marijuana As Medicine? will also be a valuable resource for policymakers, health care providers, patient counselors, medical faculty and studentsâ€"in short, anyone who wants to learn more about this important issue.

Author: George E. MacKinnon III
Publisher: Jones & Bartlett Publishers
ISBN: 1449673945
Category : Medical
Languages : en
Pages : 241

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Book Description
Understanding Health Outcomes and Pharmacoeconomics presents an overview of the tools used to assess patient-related health status including associated health outcomes and the analyses that are used to determine cost-effectiveness in evaluating pharmacotherapeutic interventions to improve health. Including data and examples from several different countries, this comprehensive text will help students understand the basis for decisions made at the local and governmental level that impact the use of pharmaceuticals and provide a strong foundation for understanding the principles used in cost-effective decision making. With commentaries, cases studies, and highlighting international differences, this text concludes with a discussion of the need for a universal system for documenting medication use. Understanding Health Outcomes and Pharmacoeconomics provides definitions of comparative effectiveness research (CER) and comparisons of pharmacoeconomic models (including cost-effectivess, cost-benefit, and cost utility analyses). This inclusive text provides describes how CER is linked to various pharmacoeconomic models by providing examples from clinical trials with comparative pharmacotherapy and cost parameters. From the Introduction: "The need for interprofessional education was made apparent in the 2003 Health Professions Education: A Bridge to Quality report. All healthcare professionals must be educated to deliver patient-centered care as members of an interprofessional team, emphasizing evidence-based practice, quality improvement approaches, and informatics. An enhanced understanding of pharmacoeconomic principles is a step in the right direction for healthcare practitioners as we do our best to ensure optimal medication therapy outcomes for patients and society at-large." -- George E. MacKinnon III, PhD, RPh, FASHP

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318

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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.