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Eur J Med Res. 2011 Jan 27;16(1):7-12.

Off-label use in Germany - a current appraisal of gynaecologic university departments.

Author information

1
Department of Obstetrics and Gynaecology - Großhadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377 Munich, Germany. nina.ditsch@med.uni-muenchen.de

Abstract

OBJECTIVE:

The off-label use, referring to the applicability of pharmaceutical drugs beyond the submitted and from the Federal Institute for Drugs and Medical Devices (BfArM, Bundesamt für Arzneimittel und Medizinprodukte) certified and approved administration, is the subject of controversial discussions. The application can be considered in case of severe illness - if no therapeutic alternatives are available - or it exists as a founded perspective for achieving therapeutic success.

METHODS:

A latitudinal study for evaluating the application of off-label use supplements was performed at 43 German university and academic teaching hospitals. Five doctors at each hospital applied off-label pharmaceutical drugs and were called upon to share their personal experience to the application of those medications.

RESULTS:

75 (35%) questionnaires were returned out of 22 (51%) medical centres with 215 contacted physicians. Off-label use was common for 65 (91%) of the physicians. Only 9% of them obviate the application of off-label drugs. About a half of the medication is related to application in obstetrics (54%) and in most cases on an every day basis. Uterotonics were the most commonly used off-label medications (34%). The main part of information about off-label use is obtained from personal information of colleagues (66%) and personal experience (58%). 34% of physicians think that off label use is risky. Interestingly, the view about off label use of medication varies considerably among physicians from various hospitals.

CONCLUSIONS:

The application of off-label pharmaceutical drugs in Germany seems to be a well established practice. More than 90% of participators of our trial use at least one medication outside the administration. This includes particularly prostaglandins, anti-hypertonic therapeutics and chemotherapeutics.

PMID:
21345764
PMCID:
PMC3351949
[Indexed for MEDLINE]
Free PMC Article
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