Ein Vergleich von Fachinformationen immunsuppressiver Medikamente in Italien, Deutschland und England hinsichtlich ihrer freien Verfügbarkeit im Internet, ihrer Entwicklung und inhaltlicher Unterschiede zwischen 2004 und 2010

Tina Simone Schnitzbauer
2013
Summaries of Product Characteristics (SPCs) are an important source to look up drug interactions, dosing recommendations and side effects in the particular area of indication. Moreover, nowadays patients do have a distinguished desire to receive more information about drugs they have to take. SPCs may also serve as source documents in the assessment of adverse events in clinical trials. The world-wide-web - majorly pharmaceutical company websites and national databases - is one of the major
more » ... ne of the major indispensable reference sources for freely available SPCs. Additionally, the European Medicine Agency (EMA) established a large database defined by an EU-guideline until 2008 to harmonize information within the country-specific SPCs. In this thesis we compared SPCs of the immunosuppressive drugs Sandimmun®, Prograf®, Rapamune® und Cell Cept® from Germany, England and Italy from the years 2004 to 2010 concerning free availability in the internet, development of differences over time and contents on the basis of the last available version in the world-wide-web. Our hypotheses were (I) that free availability of SPCs from homepages of pharmaceutical companies - besides the database of the EMA - was hardly given for physicians as well as for patients. (II) Prior to establishment of the EMA database, country specific SPCs revealed fundamental differences amongst each other. The implementation of the EU-directive 2001/83/EC, represented by the establishment of an international database launched by the EMA led to an access to harmonized country specific SPCs. However, Sandimmun® can not be found in the database and is still an exemption from this harmonization. Although the amount and quality of information in country specific SPCs was increased over the last century, there are still differences present between information freely available in the internet and the EMA database. Freely available SPCs are thus an insecure source of information and recommendation for users (physicians, nurses and patients). To optimize a stepwise developm [...]
doi:10.5283/epub.28070 fatcat:ym54omimnfhmniwkegtldarx3i