Regulation of patient information leaflets in Brazil

We are delighted to hear from Carla Spinillo (pictured above) and her colleagues at Federal University of Parana that, as a result of their research-based recommendations, new regulations for Patient Information Leaflets (PILs) for homeopathic medicines have been introduced by the Secretary of Health for Parana State, Brazil. It’s hoped the regulation will serve as a reference for future national regulation.

Carla completed her PhD on the use of pictorial sequences in instructions, in the Department of Typography & Graphic Communication at Reading, in 1998. Since then she has been involved in research into communicating instructions, particularly use of visual instructions in health-related contexts.

Carla writes ‘this an unprecedented achievement for information designers in Brazil where, for the first time, experts in the field participated in the decision making process for regulatory documents in healthcare. It might also be seen as an achievement at international level, by the inclusion of guidelines for visual instructions on medicine use in PILs. These achievements are also a step forward in the regulation of drug information for patients in Brazil, as [the new regulation] considers not only aspects of readability and legibility but also of usability of PILs, grounded in empirical and theoretical research in graphic and information design.’

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