#The Perception And Management Of Drug Safety Risks 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.

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).

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.

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.

William Leiss and Christina Chociolko explain that controversies arise in part because many participants try to avoid assuming full responsibility for the consequences of the risk-taking they advocate. For example, one can indulge in the pleasure of nicotine addiction despite an awareness of the health risks and count on a publicly funded health care system to assume the responsibility for dealing with the resulting illnesses. They provide detailed case studies of the controversies over the effects of exposure to power frequency electric and magnetic fields and to the chemical pesticides alar and antisapstains. Shorter studies of exposure to tobacco, formaldehyde, and the pesticide alachlor are also presented. The authors address the difficulties of arriving at reliable scientific estimates of risk in such controversial areas, and the impact of this uncertainty on disagreements among different interest groups over how to manage those risks responsibly. In conclusion they attempt to delineate conditions under which consensus on the assessment and management of environmental health risks might be achieved among a wide range of interest groups. Risk and Responsibility will be of specific interest to policymakers and analysts, activists, and environmentalists, and of general interest to those working in relevant industries and members of the legal profession.

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.

Books about National Library of Medicine Current Catalog

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.

A technical discussion that includes theory, research, and application, this book describes warning design standards and guidelines; aspects of law relevant to warnings such as government regulations, case/trial litigation, and the role of expert testimony in these cases; and international, health/medical, and marketing issues. Broken into thirteen major sections, the chapters cover theory, research, applications, and law, and many different perspectives on topics associated with warnings. The Selected Applications and Case Studies section highlights topics of interest and gives real world examples of problems and their solutions. No other book gives a more comprehensive treatment. This text will appeal to those whose study, work, or research concerns the design of hazard communications by linguistic, symbolic, and auditory means. The blending of research, theory, and applications also make the book attractive to safety engineers, health and medical professionals, occupational safety specialists, consumer product and industrial equipment designers, government regulators of consumer products and industrial safety, documentation writers, and plaintiff and defense attorneys involved in product- and premises-liability claims.

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.

Books about Impact of written drug information in patient package inserts. Acceptance and benefit/risk perception

First multi-year cumulation covers six years: 1965-70.