Premium
Off‐label prescriptions for atopic dermatitis in Europe
Author(s) -
Bieber T.,
Straeter B.
Publication year - 2015
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/all.12498
Subject(s) - medical prescription , medicine , european union , atopic dermatitis , context (archaeology) , off label use , quality of life (healthcare) , summary of product characteristics , dermatology , pharmacology , business , paleontology , nursing , biology , economic policy
Abstract Moderate‐to‐severe forms of atopic dermatitis ( AD ) have a substantial impact on the quality of life of patients and their relatives, carrying a significant socioeconomic burden. They often require a systemic therapy, and ciclosporine A (CsA) is the only medicinal product approved for this indication in a limited number of European countries. However, due to the safety profile of CsA and its approval conditions, this treatment can only be prescribed for a limited period of time. Thus, moderate‐to‐severe forms of AD represent a significant unmet medical need and are subject to off‐label prescriptions. Besides giving some insights into the approval procedures for medicinal products in the European Union, this short review is aimed to provide some relevant background information for off‐label prescription in AD . It also provides a clinical algorithm for the off‐label prescription of systemic immunosuppressants in AD , discusses the apparent dilemma between approval and guidelines, and finally suggests practical rules to be considered in the context of off‐label prescription.