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.

Research conducted over the past two decades has shown that poor patient understanding of medication instructions is an important contributor to the more than 1 million medication errors and adverse drug events that lead to office and emergency room visits, hospitalizations, and even death. Patients who have limited literacy skills, who have multiple comorbidities, and who are elderly face the greatest risk, and limited literacy skills are significantly associated with inadequate understanding and use of prescription instructions and precautions. The Agency for Healthcare Research and Quality notes that only 12 percent of U.S. adults have proficient health literacy that allows them to interpret a prescription label correctly. Given the importance of health literacy to the proper use of medications, and the apparent lack of progress in improving medication adherence, the Roundtable on Health Literacy formed an ad hoc committee to plan and conduct a 1-day public workshop that featured invited presentations and discussion of the role and challenges regarding clarity of communication on medication. Participants focused on using health literacy principles to address clarity of materials, decision aids, and other supportive tools and technologies regarding risks, benefits, alternatives, and health plan coverage. This publication summarizes the presentations and discussions from the workshop.

Effective risk communication is essential to the well-being of any organization and those people who depend on it. Ineffective communication can cost lives, money and reputations. Communicating Risks and Benefits: An Evidence-Based User’s Guide provides the scientific foundations for effective communications. The book authoritatively summarizes the relevant research, draws out its implications for communication design, and provides practical ways to evaluate and improve communications for any decision involving risks and benefits. Topics include the communication of quantitative information and warnings, the roles of emotion and the news media, the effects of age and literacy, and tests of how well communications meet the organization’s goals. The guide will help users in any organization, with any budget, to make the science of their communications as sound as the science that they are communicating.

Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle.

THE ESSENTIAL HANDBOOK FOR EFFECTIVELY COMMUNICATING ENVIRONMENTAL, SAFETY, AND HEALTH RISKS, FULLY REVISED AND UPDATED Now in its sixth edition, Risk Communication has proven to be a valuable resource for people who are tasked with the responsibility of understanding how to apply the most current approaches to care, consensus, and crisis communication. The sixth edition updates the text with fresh and illustrative examples, lessons learned, and recent research as well as provides advice and guidelines for communicating risk information in the United States and other countries. The authors help readers understand the basic theories and practices of risk communication and explain how to plan an effective strategy and put it into action. The book also contains information on evaluating risk communication efforts and explores how to communicate risk during and after an emergency. Risk Communication brings together in one resource proven scientific research with practical, hands-on guidance from practitioners with over 30 years of experience in the field. This important guide: Provides new examples of communication plans in government and industry, use of social media, dealing with "fake news," and new digital tools for stakeholder involvement and crisis communications Contains a new chapter on partnerships which covers topics such as assigning roles and expectations, ending partnerships, and more Presents real-world case studies with key lessons all risk communicators can apply. Written for engineers, scientists, professors and students, land use planners, public health practitioners, communication specialists, consultants, and regulators, the revised sixth edition of Risk Communication is the must-have guide for those who communicate risks.

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.