Optimierung der Arzneimittelinformation zur Verbesserung der Arzneimittelsicherheit und der Qualität : Zur Notwendigkeit der Implementierung und Nutzung von Fachinformationen in der täglichen ambulanten Verordnungspraxis

Abstract

The Summary of Product Characteristics (SPC) in Germany 'Fachinformation' provides the basic information for health professionals on how to use a drug product safely and effectively. The purpose of this study was to assess the quality of the SPC and to investigate the role of the SPC for general practitioners (GPs) in Germany. An analysis of selected SPCs was made which included all SPCs of proprietary drug products launched in Germany from 2000 to 2003. The analysis showed that the prerequisites given in the SPC Guideline as well as the own criteria were fulfilled only partially. The survey among GPs revealed that the SPC plays an important role for drug information. 23 % of the physicians stated a frequent and 50 % an occasional use of the SPC. The preferred source of the SPC is the medical representative. The trustworthiness and the quality of information were assessed as 'very good' or 'good' by more than half of the physicians. In order to accomplish the intended purpose of the SPC as the most important drug information medium a number of improvements have to be realized e.g. regarding clinical relevance as well as clarity and structure of the information.