Off-label use in dermatology in Germany: what has changed since 2004.

Off-label use is defined as the usage of pharmaceuticals beyond their submitted, tested and approved use. Not only indications but also doses, route of administration, patients' characteristics and concomitant therapies are affected by the approval. In recent years, the impact of off-label use has increased markedly primarily because of the large number of new medications with often limited approval. In dermatology, a multitude of diagnoses exist which are so uncommon that they have no chance of approval studies. Experiences of off-label use often provide important scientific data that can influence or even improve further concepts of therapy. Both professional liability and mode of payment are still controversial for medications in off-label use. There is an urgent need for more legal certainty in use of off-label medication to guarantee maximum safety for patients and medical staff. Both professional societies and funding agencies should work together to resolve this problem.