Improving Drug Safety A Joint Responsibility
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Improving Drug Safety A Joint Responsibility
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Author : Rolf Dinkel
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-03-07
Improving Drug Safety A Joint Responsibility written by Rolf Dinkel and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-07 with Medical categories.
As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Swiss International Pharmaceutical Agency, and the RAD-AR Consortium. This book documents the papers presented and discussions held at this conference, which took the topic of risks and benefits of drug therapy one step further to responsibility. It includes a rich menu of issues for those who care about the evaluation of drug therapy, the ethics behind it, the expectations of the patient, and the role of traditional and nontraditional drug safety communica tions. The ideas expressed here come from different parts of the world but relate to common drug safety problems, observations, and scientific assessments; they provide insights into innovative approaches, cautious changes, and desired actions. The papers in this volume are broadly divided into conceptual perspectives (ethics, how the knowledge about drug risks and benefits is generated and appraised, the expectations in drug safety) and operational perspectives (communication, discussion, and action).
Enhancing Food Safety
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2010-11-04
Enhancing Food Safety written by National Research Council 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 2010-11-04 with Medical categories.
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Drug Safety
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Author : International Drug Surveillance Department
language : en
Publisher:
Release Date : 1991
Drug Safety written by International Drug Surveillance Department and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991 with Medical categories.
The monitoring of drug safety is an issue that affects most health care professionals. This text aims to explain the processes involved in drug surveillance and considers drug safety from the perspectives of the pharmaceutical industry, the medical profession and regulatory authorities.
Resident Duty Hours
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2009-04-27
Resident Duty Hours written by Institute of Medicine 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 2009-04-27 with Medical categories.
Medical residents in hospitals are often required to be on duty for long hours. In 2003 the organization overseeing graduate medical education adopted common program requirements to restrict resident workweeks, including limits to an average of 80 hours over 4 weeks and the longest consecutive period of work to 30 hours in order to protect patients and residents from unsafe conditions resulting from excessive fatigue. Resident Duty Hours provides a timely examination of how those requirements were implemented and their impact on safety, education, and the training institutions. An in-depth review of the evidence on sleep and human performance indicated a need to increase opportunities for sleep during residency training to prevent acute and chronic sleep deprivation and minimize the risk of fatigue-related errors. In addition to recommending opportunities for on-duty sleep during long duty periods and breaks for sleep of appropriate lengths between work periods, the committee also recommends enhancements of supervision, appropriate workload, and changes in the work environment to improve conditions for safety and learning. All residents, medical educators, those involved with academic training institutions, specialty societies, professional groups, and consumer/patient safety organizations will find this book useful to advocate for an improved culture of safety.
The Future Of Drug Safety
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-02-27
The Future Of Drug Safety written by Institute of Medicine 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 2007-02-27 with Medical categories.
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Impact Of Written Drug Information In Patient Package Inserts Acceptance And Benefit Risk Perception
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Author : Robert H. Vander Stichele
language : en
Publisher: Academia Press
Release Date : 2004
Impact Of Written Drug Information In Patient Package Inserts Acceptance And Benefit Risk Perception written by Robert H. Vander Stichele and has been published by Academia Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with categories.
Keeping Patients Safe
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2004-03-27
Keeping Patients Safe written by Institute of Medicine 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 2004-03-27 with Medical categories.
Building on the revolutionary Institute of Medicine reports To Err is Human and Crossing the Quality Chasm, Keeping Patients Safe lays out guidelines for improving patient safety by changing nurses' working conditions and demands. Licensed nurses and unlicensed nursing assistants are critical participants in our national effort to protect patients from health care errors. The nature of the activities nurses typically perform â€" monitoring patients, educating home caretakers, performing treatments, and rescuing patients who are in crisis â€" provides an indispensable resource in detecting and remedying error-producing defects in the U.S. health care system. During the past two decades, substantial changes have been made in the organization and delivery of health care â€" and consequently in the job description and work environment of nurses. As patients are increasingly cared for as outpatients, nurses in hospitals and nursing homes deal with greater severity of illness. Problems in management practices, employee deployment, work and workspace design, and the basic safety culture of health care organizations place patients at further risk. This newest edition in the groundbreaking Institute of Medicine Quality Chasm series discusses the key aspects of the work environment for nurses and reviews the potential improvements in working conditions that are likely to have an impact on patient safety.
To Err Is Human
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2000-03-01
To Err Is Human written by Institute of Medicine 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 2000-03-01 with Medical categories.
Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine
Stephens Detection Of New Adverse Drug Reactions
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Author : John Talbot
language : en
Publisher: John Wiley & Sons
Release Date : 2004-11-19
Stephens Detection Of New Adverse Drug Reactions written by John Talbot 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 2004-11-19 with Medical categories.
A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." —Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" —International Journal of Risk and Safety in Medicine
National Library Of Medicine Current Catalog
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Author : National Library of Medicine (U.S.)
language : en
Publisher:
Release Date : 1991
National Library Of Medicine Current Catalog written by National Library of Medicine (U.S.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991 with Medicine categories.