Pharmaceutical Regulatory Affairs: Open Access

Beate Beime

Publications

• Research Article
  Does the Requirement of Readability Testing Improve Package Leaflets? Evaluation of the 100 Most Frequently Prescribed Drugs in Germany Marketed before 2005 and First Time in 2007 or After
  Author(s): Beate Beime and Klaus MengesBeate Beime and Klaus Menges
  
  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 t.. Read More»
  DOI: 10.4172/2167-7689.1000102

  Abstract PDF