Using the German National Medication Plan for Clinical Studies in Practice-Based Research Networks.

Abstract

The German National Medication Plan (GNMP) can be a valuable and interoperable data source for clinical studies, due to its digital specification and mandatory provisioning for chronically ill patients. Digital transfer of a patients current GNMP from the Patient Data Management System (PDMS) into electronic case report forms would avoid error prone manual data capturing. It is also essential for studies in practice-based research networks (PBRN), where data capturing must have as little impact as possible on everyday practice. The following issues are currently preventing seamless digital integration: There is no standardized interoperable export of the GNMP from PDMS. In the current form, pharmaceutical catalogs are needed to decode the contained pharmaceutical registration numbers. As accessibility to the pharmaceutical catalogs is restricted, there is no generic access to the actual information needed for study data evaluation. In order to conduct studies, feasible workarounds for these issues had to be implemented in the standard operating procedures, tools and participating GP practices. To overcome the GNMP's current lack of digital interoperability, the proposed solution combines semi-automated data export from PDMS at the GP practice and manual database search at the study center with a semi-automated processing pipeline to balance workload between GP practices, study management and evaluation.