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Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
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Book Description
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
Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
Get Book Here
Book Description
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
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309038294
Category : Medical
Languages : en
Pages : 709
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309091942
Category : Medical
Languages : en
Pages : 369
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309218160
Category : Medical
Languages : en
Pages : 292
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Book Description
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
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.
Author: Program on Forced Migration and Health at the Mailman School of Public Health of Columbia University
Publisher: National Academies Press
ISBN: 0309086159
Category : Medical
Languages : en
Pages : 181
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Book Description
Admittedly, the world and the nature of forced migration have changed a great deal over the last two decades. The relevance of data accumulated during that time period can now be called into question. The roundtable and the Program on Forced Migration at the Mailman School of Public Health of Columbia University have commissioned a series of epidemiological reviews on priority public health problems for forced migrants that will update the state of knowledge. Malaria Control During Mass Population Movements and Natural Disasters- the first in the series, provides a basic overview of the state of knowledge of epidemiology of malaria and public health interventions and practices for controlling the disease in situations involving forced migration and conflict.
Author: Brian L. Strom
Publisher: Springer Science & Business Media
ISBN: 1489925872
Category : Medical
Languages : en
Pages : 171
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Book Description
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.
Author:
Publisher: DIANE Publishing
ISBN: 1428924256
Category :
Languages : en
Pages : 67
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Book Description
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309171334
Category : Law
Languages : en
Pages : 423
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Book Description
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.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
