RESUMO
Objetivo: Analizar la responsabilidad del personal sanitario alelaborar reformulaciones (modificación de la dosis, forma farmacéuticao vía de administración de especialidades farmacéuticas)desde la jurisprudencia del Tribunal Supremo y la AudienciaNacional.Método: Búsqueda y análisis de jurisprudencia y estudios jurídicosen las bases de datos El Derecho, Difusión Jurídica eIndret.Resultados: El personal sanitario tiene una obligación demedios no de resultados aplicando unas normas de cuidadoque constituyen la Lex Artis, y que pueden ir más allá de lasmeras normas jurídicas. La falta a estas normas de cuidado, ladenegación de auxilio o la falta de respeto a la autonomía delpaciente pueden ser comportamientos negligentes. Se encontraron4 casos en la jurisprudencia. En los dos casos en que secumplieron las normas de cuidado, incluyendo la reformulación,los profesionales sanitarios fueron absueltos, mientras queen otros dos casos en que no se aplicaron reformulaciones,cuando las Lex Artis así lo imponía, los profesionales fueroncondenados.Conclusiones: La reformulación de especialidades farmacéuticas,incluidas en la Lex Artis, es una práctica aceptada por elTribunal Supremo y la Audiencia Nacional, siendo causa de condenael no recurrir a las mismas cuando los conocimientos científicosdel momento así lo aconsejen
Objective: To analyze the responsibility of health care staff indrug reformulation (change of dose, pharmaceutical form or routeof administration of medicinal products) based on the commonlaw of the High Court and the National Court.Method: Search and analysis of common law and legal studiesincluded in databases El Derecho, Difusión Jurídica andIndret.Results: Health care staff has means not outcomes obligationsaccording to the care standards included in the Lex Artisthat can go beyond the mere legal standards. Failure to apply thiscare standards, denial of assistance or disrespect to the autonomyof the patient can be negligent behaviors. We found 4 cases incommon law. In the two cases in which care standards were compliedwith, including reformulation, health care professionals wereacquitted, whereas in the other two cases in which reformulationswere not used even though the Lex Artis required them, theprofessionals were condemned.Conclusions: Reformulation of medicinal products, as setforth in the Lex Artis, is a practice accepted by the High Courtand the National Court and failure to use it when the scientificknowledge advises so is a cause for conviction
Assuntos
Humanos , Legislação Farmacêutica/tendências , Uso de Medicamentos/legislação & jurisprudência , Posologia Homeopática/legislação & jurisprudência , Serviço de Farmácia Hospitalar/ética , Composição de Medicamentos/tendências , Responsabilidade Legal , JurisprudênciaRESUMO
OBJECTIVE: To analyze the responsibility of health care staff in drug reformulation (change of dose, pharmaceutical form or route of administration of medicinal products) based on the common law of the High Court and the National Court. METHOD: Search and analysis of common law and legal studies included in databases "El Derecho", "Difusión Jurídica" and "Indret". RESULTS: Health care staff has means--not outcomes--obligations according to the care standards included in the "Lex Artis" that can go beyond the mere legal standards. Failure to apply these care standards, denial of assistance or disrespect to the autonomy of the patient can be negligent behavior. We found 4 cases in common law. In the two cases in which care standards were complied with, including reformulation, health care professionals were acquitted, whereas in the other two cases in which reformulations were not used even though the "Lex Artis" required them, the professionals were condemned. CONCLUSIONS: Reformulation of medicinal products, as set forth in the Lex Artis, is a practice accepted by the High Court and the National Court and failure to use it when the scientific knowledge advises so is a cause for conviction.
