The Perception And Management Of Drug Safety Risks

Author : Bruno Horisberger,Rolf Dinkel
Publisher : Springer Science & Business Media
Page : 219 pages
File Size : 43,9 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9783642742729

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The Perception and Management of Drug Safety Risks by Bruno Horisberger,Rolf Dinkel Pdf

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.

Author : Rolf Dinkel,Bruno Horisberger,Kenneth W. Tolo
Publisher : Springer Science & Business Media
Page : 338 pages
File Size : 50,5 Mb
Release : 2013-03-07
Category : Medical
ISBN : 9783642612503

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Improving Drug Safety — A Joint Responsibility by Rolf Dinkel,Bruno Horisberger,Kenneth W. Tolo Pdf

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).

Author : Paul Slovic
Publisher : Routledge
Page : 512 pages
File Size : 47,8 Mb
Release : 2016-10-06
Category : Business & Economics
ISBN : 9781317341123

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The Perception of Risk by Paul Slovic Pdf

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.

Author : Jonathan B. Wiener,Michael D. Rogers,James K. Hammitt,Peter H. Sand
Publisher : Routledge
Page : 602 pages
File Size : 47,6 Mb
Release : 2013-05-13
Category : Law
ISBN : 9781136522567

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The Reality of Precaution by Jonathan B. Wiener,Michael D. Rogers,James K. Hammitt,Peter H. Sand Pdf

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.

Author : Jonathan Baert Wiener
Publisher : Routledge
Page : 602 pages
File Size : 54,6 Mb
Release : 2011
Category : Business & Economics
ISBN : 9781933115863

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The Reality of Precaution by Jonathan Baert Wiener Pdf

First Published in 2010. Routledge is an imprint of Taylor & Francis, an informa company.

Author : Bryan R. Luce,Anne Elixhauser
Publisher : Springer Science & Business Media
Page : 184 pages
File Size : 50,7 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9783642754906

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Standards for the Socioeconomic Evaluation of Health Care Services by Bryan R. Luce,Anne Elixhauser Pdf

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.

Author : Philip C.R. Gray,Richard M. Stern,Marco Biocca
Publisher : Springer Science & Business Media
Page : 427 pages
File Size : 42,5 Mb
Release : 2013-04-18
Category : Technology & Engineering
ISBN : 9781475728941

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Communicating about Risks to Environment and Health in Europe by Philip C.R. Gray,Richard M. Stern,Marco Biocca Pdf

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.

Author : William Leiss,Christina Chociolko
Publisher : McGill-Queen's Press - MQUP
Page : 423 pages
File Size : 51,6 Mb
Release : 1994
Category : Champs électromagnétiques
ISBN : 9780773511774

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Risk and Responsibility by William Leiss,Christina Chociolko Pdf

Controversies over how to manage health and environmental risks are among the most bitter disagreements in contemporary society. Trying to determine what is in the public interest is at the heart of these disagreements, but the core concerns of major sectors industry, governments, and voluntary associations are also at stake. In Canada and elsewhere, defusing the controversies and finding solutions acceptable to all parties have met with little success. Risk and Responsibility attempts to explain why this is so and what might be done about it.

Author : Robert H. Vander Stichele
Publisher : Academia Press
Page : 250 pages
File Size : 42,7 Mb
Release : 2004
Category : Electronic
ISBN : 9038206186

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Impact of written drug information in patient package inserts. Acceptance and benefit/risk perception by Robert H. Vander Stichele Pdf

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 54,6 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570

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Pain Management and the Opioid Epidemic by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse Pdf

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.

Author : Priya Bahri
Publisher : Springer Nature
Page : 523 pages
File Size : 48,9 Mb
Release : 2020-06-17
Category : Medical
ISBN : 9789811530135

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Communicating about Risks and Safe Use of Medicines by Priya Bahri Pdf

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.

Author : Qi Jiang,H. Amy Xia
Publisher : CRC Press
Page : 386 pages
File Size : 53,8 Mb
Release : 2014-12-08
Category : Mathematics
ISBN : 9781466555457

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Quantitative Evaluation of Safety in Drug Development by Qi Jiang,H. Amy Xia Pdf

State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Author : National Library of Medicine (U.S.)
Publisher : Unknown
Page : 1178 pages
File Size : 43,9 Mb
Release : 1989
Category : Medicine
ISBN : MINN:31951D00419854T

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National Library of Medicine Current Catalog by National Library of Medicine (U.S.) Pdf

Author : Jean-Michel Metry,Urs B. Meyer
Publisher : CRC Press
Page : 216 pages
File Size : 47,6 Mb
Release : 1998-01-30
Category : Medical
ISBN : 0471971227

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Drug Regimen Compliance by Jean-Michel Metry,Urs B. Meyer Pdf

This invaluable work comprehensively covers all issues of drug regimen compliance. In three sections--Clinical Trials, Patient Management, and Future Aspects--it deals with a topic of debate and interest.

Author : Geraint G. Howells
Publisher : Manchester University Press
Page : 240 pages
File Size : 45,7 Mb
Release : 1991
Category : Insurance, Products liability
ISBN : 0719033748

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Product Liability, Insurance, and the Pharmaceutical Industry by Geraint G. Howells Pdf

A collection of papers from the ninth Fulbright Colloquium held in September 1989. The papers compare legal practices and procedures in North America and Europe and the barriers to drug development caused by increased litigation in cases involving pharmaceutical products.