[Common law study of the legal responsibility of health care staff related to drug reformulation]. / Estudio jurisprudencial de la responsabilidad legal del personal sanitario en la reformulación de medicamentos.

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.