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.

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).

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.

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.

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.

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.