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Study on off-label use of medicinal products in the European Union.

Weda, M., Hoebert, J., Vervloet, M., Moltó Puigmarti, C., Damen, N., Marchange, S., Langedijk, J., Lisman, J., Dijk, L. van. Study on off-label use of medicinal products in the European Union. Utrecht/Bilthoven: NIVEL, epha, RIVM, 2017.
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European Union (EU) legislation on marketing authorisation of medicinal products aims to safeguard public health and to protect the free movement of these products. As part of this authorisation, the terms under which a product can be used safely and effectively are described in the product information. However, medicinal products might be prescribed and used outside these terms; this is what is called ‘off-label use’. This report describes a study on the complex field of off-label use. It covers the public health aspects related to the off-label use of medicinal products. In particular, it investigates the balance between the benefits and risks that off-label use has for patients, and the regulatory framework for the off-label use of medicines.
Applying a wide range of methods, including a systematic review of scientific literature and grey literature, a legal analysis, interviews with stakeholders and an expert meeting, this study provides information on a variety of aspects of off-label use. These include the prevalence and incidence of off-label use and its drivers as well as a description of the national frameworks, regulatory and other, governing off-label use of medicinal products in the various EU Member States. A factual analysis is provided of how authorities have addressed the issue of off-label use and the different ways patients, healthcare professionals and industry react to this. The report does not provide any recommendations. (aut. ref.)