The Perception And Management Of Drug Safety Risks

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.

Today's therapeutic drugs are capable of beneficial results but can also cause great harm, especially if administered to the wrong patient in the wrong dosage. This book is devoted to the perception, measurement and management of therapeutic risk, and outlines the results of a conference on the subject held in Brighton, Sussex in June 1987 - a joint enterprise between the Trust for Education and Research in Therapeutics, London, and the Drug Safety Research Trust, Southampton. It examines the results of dispensing drugs, the rarity or seriousness of attendant risks involved and the manner in which therapeutic drugs can be measured and controlled.

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).

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.

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.

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. Features, Focuses on the quantitative evaluation of safety of biopharmaceutical products, Covers several Bayesian approaches, including a meta-experimental design for evaluating cardiovascular risk, adaptive trials for drug safety, and network meta-analysis for safety evaluation, Explains why a DMC safety report differs from a safety report written at the end of the trial, Describes the safety surveillance and signal detection process, Discusses the observational medical outcomes partnership (OMOP), Addresses regulatory issues in the meta-analysis of safety data, Presents safety evaluation and quantitative approaches during preclinical and early phases of drug development, 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. Book jacket.

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.

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