Off-Label Use of Medication

  • Rita-Marié Jansen


The term “off-label” means that a medicine is used for an indication, age group, in a dose, or route other than those specified in the conditions of registration/marketing authorization of the medicine and as reflected in its official labeling. The off-label use of medicine is an important part of mainstream, legitimate medical practice worldwide and accounts for an estimated 21 % of drug use overall. Medicine is generally used off-label because effective, approved drugs are scarce or are not available. It can vary between state-of-the-art treatment, standard practice, innovative use, and a “last resort.” Off-label prescription raises important questions about efficacy and safety; therefore, the benefits should be carefully balanced against the risks. This chapter gives an overview of the current regulatory framework regarding medicines and its impact on the off-label use of medication; considers the therapeutic areas where off-label use frequently occurs; outlines the legal position of prescribers; reviews the different perspectives regarding the dissemination of information on off-label use; and provides general guidance to prescribers considering off-label use.


European Union European Medicine Evaluation Agency Current Regulatory Framework Official Label Medical Journal Article 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Department of Private LawUniversity of the Free StateBloemfonteinSouth Africa

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