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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

DIA EUROPE 2018

Benefit/Risk Communication Tools that Work: Towards a Tailor-Made Drug Facts Box?

Session Chair(s)

Ragnar  Lofstedt, PhD, MA

Ragnar Lofstedt, PhD, MA

Professor of Risk Management

Kings College London, United Kingdom

In an environment that is characterised by a strong emphasis on notions such as ‘’individualised medicines’’ and ‘’ empowerment’’, patients are increasingly concerned about receiving relevant benefit/risk information in a format that is accessible as well as understandable. On both sides of the Atlantic sustained efforts have been made to meet this need by developing targeted instruments such as ’facts box ’or similar tools that present complex information about specific medicines in a clear and comprehensible way. These tools are increasingly encouraged or even initiated by drug regulators. They are developed at the interface of decision and health sciences and are likely to become an essential part of tomorrow’s benefit/risk communications between patients and healthcare professionals. The adequacy and quality of these novel instruments will need to be put to the test, and as such facts box and other tools are likely to become an increasingly important aspect of the dialogue between regulators, manufacturers and health care professionals. One of the key criteria of success will be to support people’s ability to make good decisions, based on the ability to comprehend and remember, to structure decision dimensions and alternatives or to understand the personal significance of the information. Such needs will be difficult to meet in under an undifferentiated on-size-fits all model. For example different national/cultural contexts may require to adapt the language used to address specific concerns or to deal with sensitivities. Different age groups may require different tools. Overall, recent literature on ageing and decision making has found, for several reasons and in many ways, discrepancies between the decision-making competence of younger and older individuals. Older individuals, for instance, tend to find it more difficult to deal with numeric processing; they also tend to rely more on personal experience and general knowledge than written advice. This panel will bring together key actors from the science, patient, regulation, and manufacturing sides to explore the implications of designing sensitive benefit/communication tools.

Learning Objective : Understand the pros and cons of Drug Facts Boxes for benefit/risk decisions Undestand the pros and cons of Drug Facts Boxes for benefit/risk communcation Explain how intercultural factors shapre benefit/risk communication outcomes Explain how age factors shape benefit/risk communication outcomes

Speaker(s)

Frederic  Bouder, PhD

Panel Discussion

Frederic Bouder, PhD

University of Stavanger, Norway

Professor in Risk Management

David  Haerry

Panel Discussion

David Haerry

EUPATI Foundation,European AIDS Treatment Group, Belgium

Co-Chair Advisory Committee

Agnes  Kant, MSc

Panel Discussion

Agnes Kant, MSc

Netherlands Pharmacovigilance Centre, Netherlands

Director

Priya   Singhal, MD, MPH

Panel Discussion

Priya Singhal, MD, MPH

Biogen, United States

Senior Vice President and Global Head of Safety and Benefit Risk Management

Melanie  Carr

Panel Discussion

Melanie Carr

European Medicines Agency, Netherlands

Head of Stakeholders and Communication Division

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