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Benefit/risk communication tools that work: towards a tailor-made Drug Facts box?

What is the Future of Pharmacovigilance?

Day & Time:
April 19, 8:30AM - 10:00AM (Central Europe Standard Time)

Session Number:



Benefit/risk communication tools that work: towards a tailor-made Drug Facts box?

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(s):
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

Presentation(s) & Speaker(s):
Panel Discussion
Frederic Bouder, PhD
Associate Professor in Risk Management
Maastricht University, Norway

Panel Discussion
David Haerry
European AIDS Treatment Group, Belgium

Panel Discussion
Agnes Kant
Nederlands Bijwerkingen Centrum Lareb, Netherlands

Field Tested Strategies for How Best to Prepare Responses to Health Authority Questions
Carmen Bozic, MD, PhD
Senior Vice President, Global Development
Biogen, United States

Panel Discussion
Melanie Carr
Head of Stakeholders and Communication
European Medicines Agency (EMA), European Union, United Kingdom