The Perception And Management Of Drug Safety Risks

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The Perception and Management of Drug Safety Risks

Author : Bruno Horisberger
Publisher : Springer Science & Business Media
ISBN 13 : 3642742726
Total Pages : 219 pages
Book Rating : 4.6/5 (427 download)

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Book Synopsis The Perception and Management of Drug Safety Risks by : Bruno Horisberger

Download or read book The Perception and Management of Drug Safety Risks written by Bruno Horisberger and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past two decades public debate about the risks, benefits, and safety associated with drugs has intensified. Public disputes over risks are brought to court when individuals seek compensation for health problems attributed to a pharmaceutical product. The issue reaches legislatures and regulatory agencies when consumer advocates seek to influence the standards of drug usage. Front-page news tends to focus on accidents or other risk events with drugs. Drug risk and drug safety have become an important political issue. Drug regulat ory agencies have been instituted, and their responsibility has increased. The approval to market a drug is dependent on a set of sophisticated studies executed according to strict protocols and scientifically defined criteria. Drug surveillance activities have gained recognition, and reporting systems to identify drug safety problems have been strengthened. The understanding and management of drug safety is, nonetheless, beset by doubts, disagreements, and disputes. Conflict occurs over the significance of risk, the adequacy of evidence, the methodologies used to evaluate and measure risk, the standards that guide regulation, and the optimal means of communicating risk information to the public.

Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Improving Drug Safety — A Joint Responsibility

Author : Rolf Dinkel
Publisher : Springer Science & Business Media
ISBN 13 : 3642612504
Total Pages : 340 pages
Book Rating : 4.6/5 (426 download)

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Book Synopsis Improving Drug Safety — A Joint Responsibility by : Rolf Dinkel

Download or read book Improving Drug Safety — A Joint Responsibility written by Rolf Dinkel and published by Springer Science & Business Media. This book was released on 2013-03-07 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).

Patient Safety and Quality

Author : Ronda Hughes
Publisher : Department of Health and Human Services
ISBN 13 :
Total Pages : 592 pages
Book Rating : 4.:/5 (318 download)

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Book Synopsis Patient Safety and Quality by : Ronda Hughes

Download or read book Patient Safety and Quality written by Ronda Hughes and published by Department of Health and Human Services. This book was released on 2008 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/

The Perception of Risk

Author : Paul Slovic
Publisher : Routledge
ISBN 13 : 1317341120
Total Pages : 512 pages
Book Rating : 4.3/5 (173 download)

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Book Synopsis The Perception of Risk by : Paul Slovic

Download or read book The Perception of Risk written by Paul Slovic and published by Routledge. This book was released on 2016-10-06 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concept of risk is an outgrowth of our society's great concern about coping with the dangers of modern life. The Perception of Risk brings together the work of Paul Slovic, one of the world's leading analysts of risk, risk perception and risk management, to examine the gap between expert views of risk and public perceptions. Ordered chronologically, it allows the reader to see the evolution of our understanding of such perceptions, from early studies identifying public misconceptions of risk to recent work that recognizes the importance and legitimacy of equity, trust, power and other value-laden issues underlying public concern.

Improving Diagnosis in Health Care

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309377722
Total Pages : 473 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Improving Diagnosis in Health Care by : National Academies of Sciences, Engineering, and Medicine

Download or read book Improving Diagnosis in Health Care written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2015-12-29 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€"has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety.

Principles of Safety Pharmacology

Author : Michael K. Pugsley
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 477 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Communicating about Risks and Safe Use of Medicines

Author : Priya Bahri
Publisher : Springer Nature
ISBN 13 : 9811530130
Total Pages : 523 pages
Book Rating : 4.8/5 (115 download)

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Book Synopsis Communicating about Risks and Safe Use of Medicines by : Priya Bahri

Download or read book Communicating about Risks and Safe Use of Medicines written by Priya Bahri and published by Springer Nature. This book was released on 2020-06-17 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: At the core of this book lies the question how to approach medicines, risks and communication as a researcher - or anybody planning and evaluating a communication intervention, or wanting to understand communication events in private and the media. With a view to tackle current shortcomings of communication systems and processes for improved implementation, patient satisfaction and health outcomes, a multilayered approach is presented. This combines multiple data types and methods to obtain a wider and deeper understanding of the major parties and their interactions, as well as the healthcare, social and political contexts of information flows, how they interfere and which impact they have. Illustrated with real life experiences of safety concerns with medicines, worldwide active experts discuss the methods and contributions their disciplines can offer. With considerations on terminologies, tabulated overviews on communication types and outcomes, a patient-centred vision and plain language for non-medical readers, the book creates a platform for multidisciplinary collaborations amongst researchers as well as practitioners from communications, healthcare, the social sciences and pharmacovigilance. Importantly, it advocates for an active role of patients and highlights the achievements and aspirations of patient organisations. Finally, the book suggests establishing an inclusive discipline of humanities and epidemiology of medicinal product risk communication to realise full research potential. The authors are driven by the curiosity for communication as the most human behaviour, and as good health is amongst the basic human needs, medicinal product risk communication is an exciting research field of high global relevance.

Stephens' Detection and Evaluation of Adverse Drug Reactions

Author : John Talbot
Publisher : John Wiley & Sons
ISBN 13 : 1119952107
Total Pages : 751 pages
Book Rating : 4.1/5 (199 download)

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Book Synopsis Stephens' Detection and Evaluation of Adverse Drug Reactions by : John Talbot

Download or read book Stephens' Detection and Evaluation of Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2011-10-28 with total page 751 pages. Available in PDF, EPUB and Kindle. Book excerpt: The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal

Keeping Patients Safe

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309187362
Total Pages : 485 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Keeping Patients Safe by : Institute of Medicine

Download or read book Keeping Patients Safe written by Institute of Medicine and published by National Academies Press. This book was released on 2004-03-27 with total page 485 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Preventing Medication Errors

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133734
Total Pages : 480 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Preventing Medication Errors by : Institute of Medicine

Download or read book Preventing Medication Errors written by Institute of Medicine and published by National Academies Press. This book was released on 2006-12-11 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

Standards for the Socioeconomic Evaluation of Health Care Services

Author : Bryan R. Luce
Publisher : Springer Science & Business Media
ISBN 13 : 3642754902
Total Pages : 272 pages
Book Rating : 4.6/5 (427 download)

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Book Synopsis Standards for the Socioeconomic Evaluation of Health Care Services by : Bryan R. Luce

Download or read book Standards for the Socioeconomic Evaluation of Health Care Services written by Bryan R. Luce and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the past decades, health care delivery - once characterized by clearly defined relationships between medical professionals, regulators, and industr- has become much more complex. Traditional roles and relationships are changing and new decision-makers are entering the scene. They bring into the discussion the need for cost containment and the changing perceptions of the public with regard to the risks and benefits of health care outcomes. As benefits of medical care are increasingly questioned and as scepticism and fear of advanced technologies are demonstrated by a growing body of people, decision making must move beyond medical concerns to encompass economic, political, and sociological considera tions. This evolution has also affected the pharmaceutical industry. Public percep tion of responsibility for product safety is no longer limited to regulators and physi cians. Manufacturers, previously unencumbered by social policies, governmental preoccupations, or public expectations, are now held accountable for product safety. As a certain amount of risk acceptance is, however, a prerequisite for the further development of health care goods, it has to be carefully balanced against society'S demand for safety. To weigh risks against benefits, to define acceptable risk, and to exclude what no longer falls within this category remain perpetual challenges. Accordingly, health care outcomes have to be assessed not only from a clinical point of view, but also from an economic and societal perspective. The assessment of drug risks and benefits has become an important political issue world-wide.

The Reality of Precaution

Author : Jonathan B. Wiener
Publisher : Routledge
ISBN 13 : 1136522565
Total Pages : 602 pages
Book Rating : 4.1/5 (365 download)

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Book Synopsis The Reality of Precaution by : Jonathan B. Wiener

Download or read book The Reality of Precaution written by Jonathan B. Wiener and published by Routledge. This book was released on 2013-05-13 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 'Precautionary Principle' has sparked the central controversy over European and U.S. risk regulation. The Reality of Precaution is the most comprehensive study to go beyond precaution as an abstract principle and test its reality in practice. This groundbreaking resource combines detailed case studies of a wide array of risks to health, safety, environment and security; a broad quantitative analysis; and cross-cutting chapters on politics, law, and perceptions. The authors rebut the rhetoric of conflicting European and American approaches to risk, and show that the reality has been the selective application of precaution to particular risks on both sides of the Atlantic, as well as a constructive exchange of policy ideas toward 'better regulation.' The book offers a new view of precaution, regulatory reform, comparative analysis, and transatlantic relations.

The Reality of Precaution

Author : Jonathan Baert Wiener
Publisher : Routledge
ISBN 13 : 1933115866
Total Pages : 602 pages
Book Rating : 4.9/5 (331 download)

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Book Synopsis The Reality of Precaution by : Jonathan Baert Wiener

Download or read book The Reality of Precaution written by Jonathan Baert Wiener and published by Routledge. This book was released on 2011 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: First Published in 2010. Routledge is an imprint of Taylor & Francis, an informa company.

Communicating about Risks to Environment and Health in Europe

Author : Philip C.R. Gray
Publisher : Springer Science & Business Media
ISBN 13 : 1475728948
Total Pages : 427 pages
Book Rating : 4.4/5 (757 download)

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Book Synopsis Communicating about Risks to Environment and Health in Europe by : Philip C.R. Gray

Download or read book Communicating about Risks to Environment and Health in Europe written by Philip C.R. Gray and published by Springer Science & Business Media. This book was released on 2013-04-18 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public experience with risk communication differs greatly from country to country in Europe and there has been little opportunity for the transfer of experience and learning between countries. This is especially true for the many new European States, including the countries in transition from centralised to market economies. This book presents case studies on risk communication. One of its unifying concepts is the role of risk communication in the risk management process. Technical and philosophical introductions to risk communication and risk management and research in risk communication are given. The case studies themselves occupy the central portion of the book, each one covering a particular hazard, risk or situation seen from a particular point of view. The issue of the special circumstances for environmental and health risk communication in central and eastern Europe is also addressed through a separate presentation and discussion of an appropriate case study. A different approach to risk communication is taken by examining how it forms part of the risk management process at the local level. Research into risk perception, a field that forms an important foundation for many aspects of risk communication, is summarised and practical guidelines for risk communication are reviewed. These include discussions on how to carry out public information programmes and methods for increasing public involvement in risk management decisions.

Managed Care Pharmacy Practice

Author : Navarro
Publisher : Jones & Bartlett Publishers
ISBN 13 : 076378883X
Total Pages : 659 pages
Book Rating : 4.7/5 (637 download)

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Book Synopsis Managed Care Pharmacy Practice by : Navarro

Download or read book Managed Care Pharmacy Practice written by Navarro and published by Jones & Bartlett Publishers. This book was released on 2008-12-11 with total page 659 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managed Care Pharmacy Practice, Second Edition offers information critical to the development and operation of a managed care pharmacy program. The text also covers the changes that have taken place within the delivery of pharmacy services, as well as the evolving role of pharmacists.

To Err Is Human

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309068371
Total Pages : 312 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis To Err Is Human by : Institute of Medicine

Download or read book To Err Is Human written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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