Pharmaceutical Regulatory Affairs: Open Access

Objectives: Based on the “Action Plan 2008/2009 for Improving Drug Therapy Safety” issued by the German Federal Ministry of Health, the Federal Institute for Drugs and Medical Devices (BfArM) has launched a study on the effect of readability user tests on the quality of Package Leaflets (PLs).

Methods: Based on recommendations from the EU Readability Guideline, a criteria catalogue for the analysis of PLs has been set up, serving as surrogate parameters for readability of statements within the PL. 100 of the most frequently prescribed medicinal products in Germany were selected and their readability analyzed. The study was blinded.

Results: This study shows that merely 44% of the 100 most frequently prescribed medicinal products in Germany have PLs with a “normal” or better readability. PLs on the market since 2007 show a trend towards improvement when compared with products marketed before 2005. This effect was even more pronounced with the 23 PLs tested as required.

Conclusions: The new European legislation in force by the end of 2005 induced a trend towards better usable PLs. On the average, however, this effect is barely recognisable. Only new products on the market need to be tested in regard to readability. Simultaneously, the text extent increased – a considerable effect against the intended improvement.

Practice implications: Apart from text required to be short as possible, of short sentences, simple and clearly written, other legal requirements influence the length of PLs: These conflicts cannot be resolved as long as the entire SmPC needs to be mentioned in the PL due to Medicinal Product Act and liability provisions Nowadays, other (technical) solutions should be legally confirmed to present the content of a PL with a good design in different ways according to the need of each of different user groups.