86306 20230914083237.0 doi 10.1007/s40267-018-0590-3 sideral 109915 ART-2019-109915 eng Frutos Pérez-Surio, Alberto Universidad de Zaragoza (orcid)0000-0001-9962-3387 The use of medicines in exceptional circumstances in Spain: adding perspective to early access 2019 Access copy available to the general public Unrestricted The use of medicines in exceptional circumstances refers to the use of non-authorized medicines or those used outside the authorized conditions, and comprises three different situations: (1) the use of medication in research or for compassionate use; (2) the use of foreign medicines (medicines unauthorized in one country but authorized in others); and (3) off-label use (prescription of drugs for conditions other than that for which they have been officially approved). In Spain, we intend to regulate the period between authorization and pricing through the use of therapeutic positioning reports containing standard criteria. In our opinion, the key to managing this period could be restrictive access based on the therapeutic positioning reports, prespecified agreements on acquisition cost, and restrictive time framework (for use or for decision making, e.g. orphan medicines). info:eu-repo/semantics/openAccess All rights reserved http://www.europeana.eu/rights/rr-f/ 0.115 2019 Pharmacology (medical) 2019 Q4 info:eu-repo/semantics/article info:eu-repo/semantics/acceptedVersion Lozano Ortiz, Roberto 1008 615 Universidad de Zaragoza Dpto. Microb.Med.Pr.,Sal.Públ. Área Medic.Prevent.Salud Públ. 35, 2 (2019), 86-92 Drugs ther. perspect. Drugs & therapy perspectives 1172-0360 154050 http://zaguan.unizar.es/record/86306/files/texto_completo.pdf Postprint 122265 http://zaguan.unizar.es/record/86306/files/texto_completo.jpg?subformat=icon icon Postprint oai:zaguan.unizar.es:86306 articulos driver 2023-09-13-10:46:12 ARTICLE