Off-label prescription, informed consent and electronical records in Portuguese law

• Autor(a) principal: Barbosa, Carla
• Data de Publicação: 2016
• Outros Autores: Matos, Mafalda Francisco
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
• Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/329
• topic: prescrição de medicamentos; prescrição off-label; consentimento informado; processo clínico; Medicine’s Prescription. Off-Label. Informed Consent. Electronical Records. Clinical Records.; Prescripción de Medicamentos. Prescripción Off-Label. Consentimento Informado. Historia Clínica Electrónica.

Off-label prescription of a medicine is not only common and a widely accepted practice, but also unavoidable in modern health systems. A practitioner tasked with treating patients in this real world, facing a lack of useful therapy, cannot wait for all the procedure to get a licensed medicine use. However, there is still no regulation of this kind of prescription in Portugal (or Europe). As a physician’s prerogative, therapy freedom must guarantee the patient’s respect, reason why he/she must be fully informed. It is imperative that the patient knows the particular therapy, its potential risks and benefits and the reasons that led the practitioner to prescribe off-label. Besides all information should be comprehensibly noted in the patient’s clinical records to ensure protection for both patient and physician.Although there is no consensus about the form of off-label prescription’s informed consent, in 2014, an administrative guideline from DGS (Portuguese Health’s Direction) recommends a written form.The problem is: how to adjust this demand with the growing informatization of the clinical records and with mechanisms like the Portuguese Health Data Platform? In fact, this is a common health problem. Recently, FDA (U.S. Food and Drug Administration) published a draft guidance that provides recommendations on procedures using an electronic informed consent.