Beatriz Alonso Gómez, Servicio de Farmacología Clínica, Hospital Universitario Marqués de Valdecilla, Santander, España
María de los Ángeles Pena Pardo, Servicio de Farmacología Clínica, Hospital Universitario Marqués de Valdecilla, Santander, España
María del Mar García Saiz, Servicio de Farmacología Clínica, Hospital Universitario Marqués de Valdecilla, Santander, España

The use of medicines for unauthorised conditions, usually called off-label use, is a widespread practice in all countries and in many specialties. In Spain, the use of medicines in special situations is regulated by Royal Decree 1015/2009, which contemplates the use of medicines under conditions different from those authorised, the compassionate use of medicines under investigation, and the use of foreign medicines authorised in another country. These uses are considered exceptional, and are indicated for patients suffering from chronic or serious diseases for which there are no authorised medicines that offer an effective therapeutic option. The administrative authorisation of this practice is different according to the type of special use, and may vary according to the health centre or the Autonomous Community. It is essential to obtain the patient’s written informed consent before the drug is administered, as well as adequate follow-up to ensure the efficacy of the treatment, which is sometimes unknown, and to verify its safety. The notification of any suspected adverse reaction detected during the use of these medicines should be reported following Pharmacovigilance practices.

Keywords: Unauthorised use. Off-label use. Compassionate use. Foreign medicines. Informed consent. Pharmacovigilance.