Administración de medicamentos en dosis o pautas de administración diferentes a las estipuladas en su ficha técnica

The prescription, manipulation or administration of medicinal products in doses or administration forms different than the ones stipulated in the SMPC is a practice which is increasing nowadays in several Spanish hospitals. However, said practice, to be legal, has to meet the following requirements: (i) it has to be exceptional, (ii) it requires a specific and justified doctor prescription, (iii) that there are no therapeutic alternatives, (iv) the manipulation of drugs by services which duly accredited and (v) having informed the patient and obtained previously their consent.

In the event said requirements are not met, several responsibilities may arise. However, even if said requirements are verified, the healthcare professionals who prescribe medicines off label may incur in responsibilities if their action does not adjust to the lex artis ad hocin relation to the diagnosis, treatment and/or information to the patient causing them a harm or damage.