Adverse Drug Event Reporting
DOWNLOAD
Download Adverse Drug Event Reporting PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Adverse Drug Event Reporting book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Adverse Drug Event Reporting
DOWNLOAD
Author : Board on Health Sciences Policy
language : en
Publisher: National Academies Press
Release Date : 2007-04-12
Adverse Drug Event Reporting written by Board on Health Sciences Policy and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-04-12 with Medical categories.
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.
Advances In Patient Safety
DOWNLOAD
Author : Kerm Henriksen
language : en
Publisher:
Release Date : 2005
Advances In Patient Safety written by Kerm Henriksen and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Medical categories.
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Adverse Drug Events
DOWNLOAD
Author : United States. General Accounting Office
language : en
Publisher:
Release Date : 2000
Adverse Drug Events written by United States. General Accounting Office and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Drugs categories.
Registries For Evaluating Patient Outcomes
DOWNLOAD
Author : Agency for Healthcare Research and Quality/AHRQ
language : en
Publisher: Government Printing Office
Release Date : 2014-04-01
Registries For Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and has been published by Government Printing Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-01 with Medical categories.
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.
Adverse Drug Event Reporting
DOWNLOAD
Author : Steven Kolega
language : en
Publisher:
Release Date : 1996
Adverse Drug Event Reporting written by Steven Kolega and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996 with categories.
Adverse Drug Events The Magnitude Of Health Risk Is Uncertain Because Of Limited Incidence Data Report To Congressional Requesters
DOWNLOAD
Author :
language : en
Publisher: DIANE Publishing
Release Date :
Adverse Drug Events The Magnitude Of Health Risk Is Uncertain Because Of Limited Incidence Data Report To Congressional Requesters written by and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Monitoring For Adverse Drug Reactions
DOWNLOAD
Author : S.R. Walker
language : en
Publisher: Springer
Release Date : 1985-01-31
Monitoring For Adverse Drug Reactions written by S.R. Walker and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 1985-01-31 with Medical categories.
Assessment Of The Food And Drug Administration S Handling Of Reports
DOWNLOAD
Author : United States. General Accounting Office
language : en
Publisher:
Release Date : 1974
Assessment Of The Food And Drug Administration S Handling Of Reports written by United States. General Accounting Office and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1974 with Drugs categories.
Cobert S Manual Of Drug Safety And Pharmacovigilance Third Edition
DOWNLOAD
Author : Cobert Barton
language : en
Publisher: World Scientific
Release Date : 2019-04-10
Cobert S Manual Of Drug Safety And Pharmacovigilance Third Edition written by Cobert Barton and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-10 with Medical categories.
Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.
Mann S Pharmacovigilance
DOWNLOAD
Author : Elizabeth B. Andrews
language : en
Publisher: John Wiley & Sons
Release Date : 2014-06-23
Mann S Pharmacovigilance written by Elizabeth B. Andrews and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-06-23 with Medical categories.
Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.