Drug Enforcement Administrations Regulation Of Medicine
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Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 483 |
Release | : 2017-09-28 |
Genre | : Medical |
ISBN | : 0309459575 |
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 | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 318 |
Release | : 2011-11-25 |
Genre | : Medical |
ISBN | : 0309212421 |
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.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 288 |
Release | : 1999-07-10 |
Genre | : Medical |
ISBN | : 0309071550 |
The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate. This book summarizes what we know about marijuana from evidence-based medicineâ€"the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions. Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels. Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers.
Author | : |
Publisher | : DIANE Publishing |
Total Pages | : 380 |
Release | : 1993 |
Genre | : Medical |
ISBN | : 9780788104688 |
Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.
Author | : |
Publisher | : |
Total Pages | : 256 |
Release | : 1992 |
Genre | : |
ISBN | : |
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 360 |
Release | : 2005-04-13 |
Genre | : Medical |
ISBN | : 0309133424 |
Integration of complementary and alternative medicine therapies (CAM) with conventional medicine is occurring in hospitals and physicians offices, health maintenance organizations (HMOs) are covering CAM therapies, insurance coverage for CAM is increasing, and integrative medicine centers and clinics are being established, many with close ties to medical schools and teaching hospitals. In determining what care to provide, the goal should be comprehensive care that uses the best scientific evidence available regarding benefits and harm, encourages a focus on healing, recognizes the importance of compassion and caring, emphasizes the centrality of relationship-based care, encourages patients to share in decision making about therapeutic options, and promotes choices in care that can include complementary therapies where appropriate. Numerous approaches to delivering integrative medicine have evolved. Complementary and Alternative Medicine in the United States identifies an urgent need for health systems research that focuses on identifying the elements of these models, the outcomes of care delivered in these models, and whether these models are cost-effective when compared to conventional practice settings. It outlines areas of research in convention and CAM therapies, ways of integrating these therapies, development of curriculum that provides further education to health professionals, and an amendment of the Dietary Supplement Health and Education Act to improve quality, accurate labeling, research into use of supplements, incentives for privately funded research into their efficacy, and consumer protection against all potential hazards.
Author | : United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime, Terrorism, and Homeland Security |
Publisher | : |
Total Pages | : 324 |
Release | : 2008 |
Genre | : Political Science |
ISBN | : |
Author | : Kimberly New |
Publisher | : Hcpro, a Division of Simplify Compliance |
Total Pages | : 0 |
Release | : 2016-11-23 |
Genre | : Medical personnel |
ISBN | : 9781556459375 |
Drug Diversion Prevention in Healthcare Kimberly New, BSN, JD Theft of controlled substances at hospitals has always been a problem of paramount importance, but even with increased security measures, it still occurs. Drug Diversion Prevention in Healthcare discusses the issue of drug diversion in detail and demonstrates the components of a solid prevention plan. Loaded with tools and checklists, this book is designed to help hospital security officials create awareness of the drug diversion problem. You will learn how to design a program to keep staff accountable for drug administrations, as well as audits that monitor drug distribution from delivery to patient administration. This resource will help you: Establish an effective drug diversion prevention plan among hospital staff Understand the fundamental issues of drug diversion Create awareness among staff using tools and checklists Learn to recognize suspected diverters and mitigate problem areas in your hospital Effectively confront and deal with diverters in your facility
Author | : Bert Spilker |
Publisher | : |
Total Pages | : 132 |
Release | : 1990 |
Genre | : Drugs |
ISBN | : |
Author | : Bert Spilker |
Publisher | : |
Total Pages | : 640 |
Release | : 1989 |
Genre | : Business & Economics |
ISBN | : |