Download or read book Drug Safety in Developing Countries written by Yaser Mohammed Al-Worafi and published by Academic Press. This book was released on 2020-06-03 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
Download or read book The Use of Drugs in Food Animals written by National Research Council and published by National Academies Press. This book was released on 1999-01-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Technology Assessment Directory written by Institute of Medicine and published by National Academies Press. This book was released on 1988-02-01 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.
Download or read book Forging a Poison Prevention and Control System written by Institute of Medicine and published by National Academies Press. This book was released on 2004-09-16 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: Poisoning is a far more serious health problem in the U.S. than has generally been recognized. It is estimated that more than 4 million poisoning episodes occur annually, with approximately 300,000 cases leading to hospitalization. The field of poison prevention provides some of the most celebrated examples of successful public health interventions, yet surprisingly the current poison control "system" is little more than a loose network of poison control centers, poorly integrated into the larger spheres of public health. To increase their effectiveness, efforts to reduce poisoning need to be linked to a national agenda for public health promotion and injury prevention. Forging a Poison Prevention and Control System recommends a future poison control system with a strong public health infrastructure, a national system of regional poison control centers, federal funding to support core poison control activities, and a national poison information system to track major poisoning epidemics and possible acts of bioterrorism. This framework provides a complete "system" that could offer the best poison prevention and patient care services to meet the needs of the nation in the 21st century.
Download or read book Adverse Drug Event Reporting written by Board on Health Sciences Policy and published by National Academies Press. This book was released on 2007-04-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent concerns about the unexpected adverse effects of marketed drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific statins, raise concerns not only about reporting these events during premarket studies, but also about the responsibility for ongoing surveillance of drugs once they are on the market. Sometimes serious adverse drug reactions are fully appreciated only after a drug has been on the market for years. Therefore, when a drug is approved and released to the market, large numbers of patients will be exposed before all the potential adverse effects have been identified and thoroughly studied. Currently, there is no clearly defined process for addressing safety questions about drugs after premarketing research has occurred. In November 2005, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation convened a workshop to explore issues associated with the reporting of ADEs. The workshop addressed the following questions: How can ADEs be effectively identified, particularly when the adverse effects are rare? How can the direct, causal effects of drugs be distinguished from simple associations? How can health-care professionals and their patients' aid in the identification of drug-related adverse events? How can knowledge of ADEs be more effectively used in clinical practice? Adverse Drug Event Reporting reviews current sources of information on adverse drug events, including the FDA's MedWatch program and the AERS, institutional review boards, and the CMS. This report considers the ways that consumers and advocacy groups can be involved in reporting adverse events, and discusses drug interactions, problems with current databases for capturing and evaluating interactions, and difficulties in communicating information about adverse drug interactions. This report also describes new requirements for information contained on drug labels and how labels can be used to communicate information about risks and drug interactions to consumers and practitioners.
Download or read book Drug Surveillance written by Zbigniew Bańkowski and published by World Health Organization. This book was released on 1994 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Records the proceedings of an international conference convened to consider mechanisms for improving international cooperation in the surveillance of drug safety and the reporting of adverse reactions. Attended by close to 200 representatives of regulatory authorities and the pharmaceutical industry as well as clinical pharmacologists, the conference aimed to identify the strengths and weaknesses of existing mechanisms for international cooperation and to propose improvements for the future.
Download or read book Postmarketing Surveillance of Prescription Drugs written by and published by . This book was released on 1982 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Report of Joint Commission on Prescription Drug Use written by Joint Commission on Prescription Drug Use and published by . This book was released on 1980 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Download or read book Monitoring the Future National Results on Adolescent Drug Use written by and published by . This book was released on 2005 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Report of Joint Commission of Prescription Drug Use written by Joint Commission on Prescription Drug Use and published by . This book was released on 1980 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Epidemiology and Post Marketing Surveillance written by Brian L. Strom and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is a summary of material presented in the course given in the International School of Phannacology on "Drug Epidemiology and Post-Marketing Surveillance" between September 27 and October 8, 1990, at the "Ettore Majorana Center for Scientific Culture" in Erice, Sicily. The course, which was a NATO Advanced Study Institute, included lectures and workshops presented by experts in the new field of phannacoepidemiology. The material covered includes various approaches to spontaneous reporting of adverse drug reactions, including aggregate approaches, such as those used in France, and detailed analyses of individual reports, such as that done in The Netherlands and in Sweden. Also, included are studies using traditional epidemiology methods. In addition, modern pharmacoepidemiology makes considerable use of automated databases. As such, information is presented on their use as well. Phannacoepidemiology started in hospitals and some of the newest work in the field is returning to the hospital as a site for studies. Material on these topics was presented as well. Finally, selected new methodologic developments were outlined in specific examples presented that were of regulatory and commercial importance. This new field of phannacoepidemiology is exploding in interest internationally. Evidence of this is the increasing development of pharmacoepidemiology programs in industry, medical schools, pharmacy schools, and schools of public health. Also, there is a new International Society ofPhannacoepidemiology. Practitioners in this field tend to specialize in either analyses of spontaneous reporting or the use of formal epidemiologic techniques.
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Postmarketing surveillance of prescription drugs written by and published by DIANE Publishing. This book was released on with total page 67 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Development Regulatory Assessment and Postmarketing Surveillance written by William M. Wardell and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is the outcome of the International School of Phar macology course sponsored as a NATO Advanced Study Institute and held in Erice (Sicily) at the Ettore Majorana Centre for Scientific Culture from October 3 through 12, 1980. The course, which consisted of lectures and teaching seminars, examined issues of international importance in all phases of drug development, assessment, and regu lation. In order to recreate both the atmosphere and substance of the meeting, a variety of materials are included here: the papers pre sented by the lecturers, a selection of key items from the supple mentary materials provided by the lecturers to the participants, notes on issues raised during the discussions, and accounts of certain special sessions arranged in response to interests expressed by those attending. The course covered two broad areas represented here by parts of the book. Part I, "Drug Assessment and Regulation," is based on the nine sessions of the course that ranged in focus from recent developments in the science of clinical pharmacology and drug development to discussions of whether and how the regulation of drug development can (or should) be harmonized internationally. In Part 11, "Postmarketing Surveillance," many aspects of this important subject are presented. Arguments outlining the potential benefits of national and international postmarketing surveillance systems are qualified by consideration of the problems inherent in devising and using these systems.
Download or read book Informing America s Policy on Illegal Drugs written by National Research Council and published by National Academies Press. This book was released on 2001-09-27 with total page 423 pages. Available in PDF, EPUB and Kindle. Book excerpt: How should the war on drugs be fought? Everyone seems to agree that the United States ought to use a combination of several different approaches to combat the destructive effects of illegal drug use. Yet there is a remarkable paucity of data and research information that policy makers require if they are to create a useful, realistic policy package-details about drug use, drug market economics, and perhaps most importantly the impact of drug enforcement activities. Informing America's Policy on Illegal Drugs recommends ways to close these gaps in our understanding-by obtaining the necessary data on drug prices and consumption (quantity in addition to frequency); upgrading federal management of drug statistics; and improving our evaluation of prevention, interdiction, enforcement, and treatment efforts. The committee reviews what we do and do not know about illegal drugs and how data are assembled and used by federal agencies. The book explores the data and research information needed to support strong drug policy analysis, describes the best methods to use, explains how to avoid misleading conclusions, and outlines strategies for increasing access to data. Informing America's Policy on Illegal Drugs also discusses how researchers can incorporate randomization into studies of drug treatment and how state and local agencies can compare alternative approaches to drug enforcement. Charting a course toward a better-informed illegal drugs policy, this book will be important to federal and state policy makers, regulators, researchers, program administrators, enforcement officials, journalists, and advocates concerned about illegal drug use.
