Should Package Leaflets be Coloured in the Future?

Rubrik: Originale

(Treffer aus pharmind, Nr. 10, Seite 1428 (2018))

Fuchs J | Götze E | Voigt C

Should Package Leaflets be Coloured in the Future? / Readability Test Results from the PAINT3 Study · Fuchs J, Götze E, Voigt C · ¹PAINT-Consult®, Jena und Department of Drug Regulatory Affairs at the Institute of Pharmacy, Bonn und University of Bonn
package leaflet coloured patient information readability test package insert test QRD template For decades, package leaflets have been in regular use to communicate risks and the safe use of medicines in the European Union [ 1 – 4 ] – given that they must be delivered to patients in direct conjunction with medicines, in accordance with Article 58 of Directive 2001/83/EC. Regarding its content, “the package leaflet shall be drawn up in accordance with the summary of the product characteristics” with information being ordered as stated in Article 59(1) of this directive. Articles 59(3) and 63(2) instruct that the package leaflet must be ...

Landscape Versus Portrait Format in Package Leaflets

Rubrik: Originale

(Treffer aus pharmind, Nr. 08, Seite 1178 (2016))

Fuchs J | Götze E | Voigt C

Landscape Versus Portrait Format in Package Leaflets / Which Format Is More Suitable According to Readability Test Results From the PAINT3 Study? · Fuchs J, Götze E, Voigt C · ¹PAINT-Consult®, Jena, Germany und ²Department of Drug Regulatory Affairs at the Institute of Pharmacy, University of Bonn, Bonn, Germany
package leaflet package insert readability test landscape format portrait format Within the European Union, package leaflets are the most frequently used resource for patient information concerning medicines – given that they are included with every medicine package. Article  59(3) of Directive 2001/83/EC demands that package leaflets shall be “… legible, clear and easy to use .” [ 1 ]. To ensure this aim, article 65(c) of the quoted directive mandates the European Commission to “... draw up and publish detailed guidance concerning in particular… the legibility of particulars on the labelling and package leaflet ” – the so called readability guideline. ...