PURPOSE: Off-label drugs are being used in laryngology. Prescribing of a medicinal product is a decision taken within the relationship between a patient and his/her treating health care provider (HCP). The purpose of this article is to discuss the medicolegal aspects of off-label drug use, to provide recommendations for obtaining informed patient consent for off-label treatment and to propose the place and role of scientific societies and specialist boards in shaping good practices in this area. The final aim is to present recommendations concerning off-label usage and propose special clauses in informed patients consent. METHODS: The literature was reviewed regarding off-label applications in laryngology. Practical information on off-label use in various EU countries was collected. RESULTS: Registration data and pharmacokinetics of cidofovir, bevacizumab, Gardasil®, hyaluronic acid and mitomycin are provided. Off-label prescribing is not prohibited by EU law. Informed consent to treatment with an off-label drug exists in all EU countries. The risk that a court will accept liability of a HCP in case of off-label prescribing is higher than in case of on-label prescribing. If a HCP is held liable for the outcome of a medical treatment, the approval by the competent authorities and professional guideline is a strong defense. CONCLUSION: A patient's precise, explicit consent for the procedures including off-label drugs administration is mandatory. The second prerequisite is defining a need for creating based on recommendations by national or international scientific societies.

Department of Medical Surgical and Radiological Sciences and Public Health University of Brescia Brescia Italy

Department of Otolaryngology and Phoniatrics Head and Neck Surgery Helsinki University Hospital University of Helsinki Helsinki Finland

Department of Otorhinolaryngology and Head and Neck Surgery 1st Faculty of Medicine University Hospital Motol Charles University Prague Czech Republic

Department of Otorhinolaryngology Head and Neck Surgery Amsterdam UMC Location AMC University of Amsterdam Amsterdam The Netherlands

Department of Otorhinolaryngology Head and Neck Surgery Medical Faculty University of Cologne Cologne Germany

ENT Head and Neck Surgery Antwerp University Hospital Edegem Belgium

Faculty of Management Wroclaw University of Science and Technology Wroclaw Poland

Faculty of Medicine Wroclaw University of Science and Technology Wroclaw Poland

Research and Development Centre Regional Specialist Hospital Wroclaw Wroclaw Poland

Unit of Otorhinolaryngology Head and Neck Surgery ASST Spedali Civili of Brescia Brescia Italy

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