Masterstudiengang "Drug Regulatory Affairs"
The impact of the revised EU-legislation concerning particular needs of blind and partially-sighted patients and user testing a challenge for pharmaceutical companies with focus on Germany ***
Dr. Ursula Schickel (Abschlußjahr: 2007)
Within the framework of the revision of the European Drug Law as part of the European Directive 2004/27/EC major changes have been implemented in terms of the rules on packaging in order to ensure the proper use of medicinal products. These innovations include Braille requirements for labelling and the package leaflet to address the particular needs of blind and partially-sighted patients. Further on the compulsory consultation with target patient groups for package leaflets has been newly introduced.
Although there is no doubt about the justified request of blind and partially-sighted patients for self-determined information on medicinal products and the respective package leaflets, it should not be forgotten that meeting these requirements is associated with enormous efforts by the pharmaceutical industry. For demonstration purposes the implications for establishing Braille labelling on secondary packaging materials as well as for creating package leaflets suitable for blind and partially-sighted patients are detailed. Particular difficulties with regard to nationally different special characters in Braille for the European languages and the challenges concerning Braille labelling for multilingual packaging are pointed out. Emphasis is placed on the demanding technical aspects for Braille on folding cartons and the respective implications for the workflow within pharmaceutical companies. In addition, different approaches of some European member states with regard to package leaflets being suitable for blind and partially-sighted patients are described.
The second part of the present thesis deals with the recently implemented obligatory consultation with target patient groups for package leaflets. Patient information leaflets have always given reason for discomfort as they are judged as being too difficult and incomprehensible or even misleading and unsettling. Checking the legibility and comprehensibility of package leaflets by user testing has been established as a means to ensure the appropriateness of the contents and appearance of the leaflets. The different approaches for performing such a user testing are detailed including an illustration of weak points and disadvantages of the various test methods. Fields for further improvement of package leaflets and the respective user test procedures are figured out and discussed including proposals for sound justifications for waivers and bridging reports in certain situations as opposed to entire user testing.
Both, Braille labelling and user testing, are undoubtedly meaningful and beneficial measures for improving the safe use of medicinal products. The current regulatory requirements, however, do provide room for further improvement and clarification especially in terms of harmonisation of requirements on a European level to serve the well-being of the patients and the feasibility of the pharmaceutical companies.
Annexes: pages: 7