title: Graphical content of medicinal package inserts: an exploratory study to evaluate potential legibility issues.
abstract: BACKGROUND
  The graphical content of the Medicines Package Inserts (MPIs), such as illustrations and typographic features should be legible and appropriate, as required by international pharmaceutical regulations.
  
  
  OBJECTIVE
  To study: (1) the frequency and type of MPIs' key graphic elements, (2) their compliance with regulations and (3) how educated people understand them.
  
  
  METHODS
  Descriptive study: characterisation of the graphical content of 651 MPIs. Usability study: illustrations and tables (purposively selected) were evaluated with questionnaires in three groups of humanities undergraduates (illustrations only, illustrations plus text and text only).
  
  
  RESULTS
  Descriptive study: illustrations and tables were respectively identified in 6.3% and 11.8% of the MPIs. The illustrations were mainly related to how to take/use the medicine. Non-recommended graphical representations were found (e.g. italic or underline). Usability test: legibility issues were identified, especially for the group of isolated illustrations.
  
  
  CONCLUSIONS
  The scarce use of illustrations and tables possibly affected the legibility of the MPIs. Compulsory legibility tests are needed to guarantee the MPIs' proper use, thus contributing to a safe use of medicines. Overall, this study highlighted the need to carefully revise/assess the MPIs' design and probably increase health information experts' awareness on this issue.
authors.affiliation: Research Institute for Medicines and Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal.
authors.forename: Carla
authors.initials: C
authors.lastname: Pires
authors.affiliation: Centre of Linguistics of the University of Lisbon, School of Arts and Humanities, University of Lisbon, Lisbon, Portugal.
authors.forename: Marina
authors.initials: M
authors.lastname: Vigário
authors.affiliation: Research Institute for Medicines and Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal.
authors.forename: Afonso
authors.initials: A
authors.lastname: Cavaco
mesh_terms: D000328:Adult; D032882:Comprehension; D054626:Consumer Health Information; D003430:Cross-Sectional Studies; D004348:Drug Labeling / Q000592:standards*; D004349:Drug Packaging / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male; D011174:Portugal; D013223:Statistics as Topic; D011795:Surveys and Questionnaires
keywords: communication; consumer health information; health information needs; patient information