Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
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
Drug Safety in Developing Countries
Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
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
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
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
Medical Technology Assessment Directory
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309038294
Category : Medical
Languages : en
Pages : 709
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.
Publisher: National Academies Press
ISBN: 0309038294
Category : Medical
Languages : en
Pages : 709
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.
Forging a Poison Prevention and Control System
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309091942
Category : Medical
Languages : en
Pages : 369
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.
Publisher: National Academies Press
ISBN: 0309091942
Category : Medical
Languages : en
Pages : 369
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.
Drug Epidemiology and Post-Marketing Surveillance
Author: Brian L. Strom
Publisher: Springer Science & Business Media
ISBN: 1489925872
Category : Medical
Languages : en
Pages : 171
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.
Publisher: Springer Science & Business Media
ISBN: 1489925872
Category : Medical
Languages : en
Pages : 171
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.
Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309218160
Category : Medical
Languages : en
Pages : 292
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.
Publisher: National Academies Press
ISBN: 0309218160
Category : Medical
Languages : en
Pages : 292
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.
Malaria Control During Mass Population Movements and Natural Disasters
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
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.
Publisher: National Academies Press
ISBN: 0309086159
Category : Medical
Languages : en
Pages : 181
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.
Postmarketing surveillance of prescription drugs.
Author:
Publisher: DIANE Publishing
ISBN: 1428924256
Category :
Languages : en
Pages : 67
Book Description
Publisher: DIANE Publishing
ISBN: 1428924256
Category :
Languages : en
Pages : 67
Book Description
Informing America's Policy on Illegal Drugs
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309171334
Category : Law
Languages : en
Pages : 423
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.
Publisher: National Academies Press
ISBN: 0309171334
Category : Law
Languages : en
Pages : 423
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.
Medical Devices and the Public's Health
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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.
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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.
Drug Safety
Author: United States. Congress. House. Committee on Government Operations
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 650
Book Description
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 650
Book Description