gms | German Medical Science

10. Jahrestagung der GAA Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

16. bis 17.10.2003, Bonn

Summary of product information and off-label use

Fachinformation und Off-Label-Use

Meeting Abstract

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  • corresponding author Ulrike Müller - AWD.pharma GmbH & Co. KG, Leipziger Str. 7 - 13, 01097 Dresden, Germany, Tel.: 0351/834-1190, Fax: -1135
  • M. Hippius - AWD.pharma GmbH & Co. KG, Leipziger Str. 7 - 13, 01097 Dresden, Germany

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. Doc03gaa14

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

Published: October 16, 2003

© 2003 Müller 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.



Background and Aim

Statistical analyses show that up to 20% of drug prescriptions are not covered by the marketing authorization of the drug, i. e. these drugs are used "off-label". Our aim was to investigate if the Summary of Product Characteristics (SPC) has any potential to help the physician in handling off-label use and in this way to increase drug safety.

Material and Method

We analyzed several SPCs with regard to particular aspects of off-label use to examine if an SPC might give individual information for the doctor for safer handling of this procedure.


First, the SPC as the central document of drug marketing authorization can help the doctor to identify an off-label use since each therapy which is covered by the SPC can be considered as "non-off-label". The criteria for off-label include a non-existing indication of a drug but also the use contrary to contraindication(s), the administration by an application route or in a dosage not covered by the marketing authorization of the drug. The doctor just has to compare these criteria with the respective chapters in the SPC such as "Contraindications"; this way it is possible to check if the therapy is covered by the marketing authorization of the drug.

Second, some information can be found to increase drug safety in case of off-label use. Data on therapy with higher dosages are usually written down in the chapter "Overdose" of the SPC. Possible consequences of non-adherence to contraindications can often be found in the chapter "Special warnings and precautions for use" and "Interactions". Usually no data is available in the SPC on an application route not covered by marketing authorization.

On the other hand the limit of the SPC is that treatment procedures not covered by the SPC do not necessarily mean that the use of the drug is unintended since unintended use of a drug is not only determined by its marketing authorization including its SPC but also by current scientific knowledge and by sales promotion of the pharmaceutical company.


Beside several legal problems and the issue of refunding by Social Health Insurance (SHI) an off-label use can be associated with an increased risk of drug safety. The SPC can help to identify off-label use and might be able to minimize its drug safety risks to some extend by providing specific information. Nevertheless, the SPC cannot give advice if the refunding criteria of the SHI are fulfilled or if the individual off-label use even presents the current state of medical knowledge.