Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Readability and comprehensibility of package leaflets - recent efforts for improvement within the EU and a historical review ***

Theresa Sorgenfrei (Abschlußjahr: 2019)

Summary
Language: English
Each medicinal product in the European Union contains a package leaflet. The purpose of the package leaflet is to inform the patient how to use the medicine appropriately and safely. The information about the therapeutic indication and possible side effects should enable the patient to make a well-informed decision. However, the legibility and comprehensibility of the package leaflet is repeatedly criticized. Often the font size appears too small, the length too extensive and the listing of the many side effects too unsettling for the patient.
This thesis intended to examine and summarise the efforts that have been made within the European Union to ensure the readability and comprehensibility of the package leaflet. In this context, the changes that have been made to laws, guidelines and templates so far were examined. Furthermore, the recent efforts of the European Commission, the European Medicines Agency and selected national competent authorities were described.
It has been found that enormous efforts have been made so far to increase the comprehensibility of package leaflets. These efforts have been made by all stakeholders, including politicians, regulatory authorities, pharmaceutical industry associations, pharmaceutical companies, user testing companies and patient organisations. Particularly with regard to the comprehensive guidelines established at national and EU level, great efforts have been made to make the package inserts more readable and understandable. However, there are still ways to make them more comprehensible. The discussion therefore focused on opportunities for individual stakeholders to contribute and on how the existing guidelines could be improved.
It is concluded that Directive 2001/83/EC provides a comprehensive legal framework for the readability and comprehensibility of package leaflets. However, the Directive should allow for the inclusion of a key information section in the package leaflet, containing important safety information that is reconciled with information on the benefits of the medicinal product. The Readability Guideline should extend its requirement for user consultation with target patient groups to all existing marketing authorisations and can be improved with regard to its design and layout recommendations. The QRD templates should be thoroughly reviewed, shortened and unimportant passages removed. The standard headings and standard statements contained in the QRD templates should be simplified and rephrased in colloquial language. In addition, communication of side effects should be revised and the needs of people with poor reading and health literacy should be better adressed.
Pages: 62, Annexes: pages: 12