Masterarbeit
Improvement of the workflow, quality and effective management of product information texts using a new database
Dr. Bettina Walter-Lorenzen (2011)
From the past until now the legal requirements in the EU and nationally in Germany have been changed a lot and the mandatory information presented in the SmPC and PIL have grown. In the first part of the thesis the legal basis and factors influencing the product information texts have been described in detail. When introducing the PILs as a mandatory document in 1989 in the EU the content of obligatory information presented in the PIL has been grown. Not all of the adjustments of the PIL are following the patients needs on readable and understandable information on the medicinal product, which will led him to trust and comply in the pharmacotherapy. Although a lot of improvements have been introduced such as readability tests and the Readability Guideline, the PILs do not meet the patients needs yet. Indeed patients wants to have shorter and easy to read PILs. The newest established changes in the QRD-templates have introduced a lot of improvements in the wording but the length of the PIL has even grown. In future the MAHs and the CAs should increase their efforts on the one hand to reduce the length of the PILs by deleting unnecessary information for the patient and on the other hand introducing more details on the benefit of the pharmacotherapy and corresponding medicinal products.
The second part of the thesis provides ideas for a better management of product information text. The role of core information texts of world-wide product information like CCDS and CCSI for the management of information presented in the used SmPCs and PILs has been described. Three different possibilities of working with SmPC and PILs like Word, PIM or TexManager have been introduced and their advantages and disadvantages have been weighed. PIM and TexManager offer advantages when compared to Word-based systems. Both systems propose the re-use of information of the text-blocks throughout product-lines and different product strength´s. Unfortunately the PIM-project has been stopped by the EMA in March 2011 although PIM has offered the major advantages of the compared systems for all MAH and CA. At the end a short description of a newly introduced data-base TexManger has been described from the company point of view. The company decided in favour of the TexManager due to it´s effectively and easy handling.