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.
Pazientearen behar kliniko konkretu baten aurrean osasun-sistema publikoko farmazia-prestazioaren barruan ez dagoen sendagairen baten beharra egon daiteke. Behar hori betetzeko hainbat aukera daude: fitxa teknikoz kanpoko erabilera (FTKE), atzerriko sendagai gisa eskuratzea, ikerketan aztergai dauden sendagaien erabilera errukiorraedo saiakuntza kliniko batean parte hartzea. Kasu horietan, eskaera berezi bat luzatu behar zaio Sendagai eta Osasun Produktuen Espainiar Agentziari (SOPEA) edo/eta ospitaleko agintariei. Aurkeztu beharreko txostenetan garbi azalduko da sendagaiaren behar ezinbestekoa eta gaixoaren baimen informatua lortzea ere derrigorrezkoa da.
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