'with all suitable means': Off-label-use and public statutory employers' liability insurance ['mit allen geeigneten Mitteln': Off-label-Use und Berufsgenossenschaften]

摘要

In Germany, responsibility for treatment of occupational diseases lies with the public statutory employers' liability insurances (SELI). According to their legal obligation SELI have to ascertain cure-wherever possible-"with all suitable means". Thus, dermatologists treating patients with occupational dermatoses are required to deliver the best possible therapy, which, according to the current scientific knowledge, may in some cases be off-label. For example, in occupational contact dermatitis a number of scientifically promising topical and systemic drugs are not yet licensed for this indication. Off-label prescribing is not prohibited and there are no laws limiting physician flexibility in such prescribing. SELI also allows the use of off-label drugs. The goals of optimal treatment or effective prevention of occupational disease determine the measures which can be employed. Off-label use is approved for occupational skin diseases when the medication is required for cure or prevention and its use meets generally accepted medical standards. In these cases, SELI will cover off-label drug prescriptions. However, detailed patient counseling and informed consent are mandatory.