gms | German Medical Science

10. Jahrestagung der GAA Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

16. bis 17.10.2003, Bonn

Examples of off-label-use in general practices analysed with the patient database Disease Analyzer-mediplus

Analyse von Off-Label-Use in niedergelassenen Praxen mit der Patientendatenbank Disease Analyzer-mediplus

Meeting Abstract

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  • corresponding author Detlef Schröder-Bernhardi - IMS HEALTH, Hahnstraße 30-32, 60528 Frankfurt/Main, Tel.: 069/6604-380, Fax: 069/6604-240
  • G. Dietlein - IMS HEALTH, Hahnstraße 30-32, 60528 Frankfurt/Main

Gesellschaft für Arzneimittelanwendungsforschung u. Arzneimittelepidemiologie (GAA) e.V.. 10. Jahrestagung der Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie (GAA) e.V.. Bonn, 16.-17.10.2003. Düsseldorf, Köln: German Medical Science; 2003. Doc03gaa12

The electronic version of this article is the complete one and can be found online at:

Published: October 16, 2003

© 2003 Schröder-Bernhardi et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Aim of the study

Prescription recommendations and behaviour in practice can be very different [1]. A partnership between physicians in practices and IMS Health exists to develop a patient database for the analyses of a pattern of questions in health care research such as: is a medication in off-label-use?


The analyses were carried out with the patient database Disease Analyzer -mediplus Germany [2]. This database provides anonymous access to a representative panel of physicians and patients. More than 1900 medical practices including nearly 9 million patients and over 119 million prescriptions can be analysed in a cross and/or longitudinal section. In comparison to other patient databases mediplus is unique in the sense that it is the only available database with direct linking of individual diagnosis and corresponding therapy.


Proton pump inhibitors (PPI) are approved for the indications ulcus and reflux but they are also off-label used for gastritis. The off-label rate varies between 30% and 40%. This global behaviour is influenced by the approval of Omeprazol for this indication. A second example shows the effect of Carvediol, which has admission for use in heart failure (24% of total number of patients), on the off-label-use of other beta-blockers in this indication (more than 10%).


The received results show high rates of off-label-use especially in the indications gastritis and heart failure. The used database mediplus is an ideal instrument for the enforcement of quantitative and qualitative analyses of issues in health care research as it combines all decision relevant information on physicians, patients, diagnoses and course of therapies. Behaviour patterns of prescribers such as off-label-use can be investigated and trends are pointed out very early.


Schröder-Bernhardi D, Dietlein G. Compliance with prescription recommendations by physicians in practices. Int J Clin Pharmacol Ther 2001;39:477-9.
Dietlein G, Schröder-Bernhardi D. Use of the mediplus patient database in healthcare research. Int J Clin Pharmacol Ther 2002;40:130-3.