What can we do when the pharmaceutical-provision of the public health system doesn't include the medications for our patient clinical needs?

Abstract

There may be situations where the clinical needs of a patient can not be covered with a drug included in the pharmaceutical-provision of the public health system. There are different options for obtaining it: off-label use, acquisition of a foreign medicine, compassionate use of research drug or participation in a clinical trial. In these cases, a special request must be made to the Spanish Agency for Medicines and Health Products and/or to the hospital authorities. The reports to be submitted will clearly state the essential need for the drug and it is also mandatory to obtain informed consent from the patient.