Sachgerechte Off-label-Verordnung in der Praxis

BACKGROUND: More than 2,000 different types of disease entities are treated in dermatology. Even for some of the more commonly occurring diseases there is no explicitly approved medication. Further limitations in the approval status can be found for skin diseases in children and adolescents, in pregnancy and with multiple comorbidities. Therefore, for medical and ethical reasons in many dermatological treatment situations prescription of medications off label is necessary. Against the background of the difficult formal and legal framework conditions for off-label prescription, knowledge of the regulations on off-label use is essential for dermatologists.

METHODEN: The presented data were taken from the essential sources of the social security statutes V (SGB V), pharmaceutical guidelines and legal texts on jurisprudence of off-label use.

RESULTS: There are no standardized regulations on off-label use for dermatological diseases in Germany. Only a few indications and pharmaceuticals have as yet been included in the processing procedure by the Federal Joint Committee. The large proportion of the necessary treatment in off-label use refers to the jurisprudence, in particular the Federal Social Court. According to this an off-label use can be justified in exceptional cases, and from the sociolegal perspective can even be demanded by patients, if the existing indications represent a serious life-threatening disease or one which permanently reduces the quality of life, a suitable therapy under approved conditions is not available and there is a well-founded prospect of successful treatment. For appropriate prescription in off-label use it is necessary to carry out an appropriate and thorough evaluation and documentation of previous treatment and of the degree of suffering on the side of the patient and to have knowledge of the international literature on studies involving the selected substance. Off-label use is involved in approximately 5-15% of necessary pharmaceutical prescriptions in dermatology and affects some 30 drugs and several hundred indications in routine treatment. Currently the CVderm is constructing a databank for dermatology called E-skin for simplification of off-label use in dermatology (http://www.arzneimittelleitfaden.de).

CONCLUSION: Prescriptions for off-label use are an integral component of qualified dermatological treatment. Despite regulatory and legal hurdles off-label use can be implemented with knowledge of the juridical and formal conditions.