[New contact allergens for patch testing. A phase-out-model?].
To insure the quality in diagnosis of allergic contact dermatitis, patch test series need to be continuously actualized. This work is done by the German Contact Dermatitis Research Group. The regulations for epidemiologic studies in patch testing have been sharpened by the recent revision of the German Drug Registration and Administration Act which defines patch test allergens to be equivalent to medications. As a result of this, the transfer of scientific data on new contact sensitizers into practice and their registration as medicines for use in patch testing are blocked. Examples for potentially relevant new sensitizers, which should be made available for routine patch testing and strategies to handle the requirements of the Drug Registration and Administration Act are discussed. In addition, the consequences of the present regulation of payment for patch testing by the German Uniform Value Scale are presented. The disconnection of the total fee for the diagnosis of allergic contact dermatitis from the number of patch tests leads to a reduced depth of diagnostic approach. In future, this may become a serious threat for the quality of patch testing in dermatology.
Becker
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Hautklinik der Johannes-Gutenberg-Universität Mainz, Langenbeckstrasse 1, 55101, Mainz. becker@hautklinik.klinik.uni-mainz.de
D000485:Allergens; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis*; D003880:Dermatology / Q000331:legislation & jurisprudence* / Q000592:standards*; D005858:Germany; D006801:Humans; D007880:Legislation, Drug; D010328:Patch Tests / Q000592:standards*; D017410:Practice Guidelines as Topic
D000485:Allergens