[Causal analysis and impact of a systematic error detected about consumption associated with trastuzumab]. / Análisis causal e impacto de un error sistemático detectado en el consumo de trastuzumab.

OBJECTIVE: determine the cause of the constant difference between the theoretical and real number of trastuzumab units consumed in an Intravenous Mixtures Unit. METHODS: was studied the manual and electronic full procedure about preparing mixtures with trastuzumab. Was performed by visual observation and review of quantitative monitoring data from the electronic preparation support and safe system of the application Farmis-Oncofarm®. RESULTS: difference between the optimum volume of trastuzumab contained in the summary of product characteristics and the same included in Farmis_Oncofarm® was found. Also found a defect of the optimum volume of 10ml syringes used in the reconstitution vials process. CONCLUSIONS: the default in the optimal volume of 10ml syringes used in the reconstitution process increases the real consumed units of trastuzumab. This produces a significant economic impact calculated in an annual additional cost in approximately 46.508 € without negative consequences for the patient.

Objetivo: determinar la causa de la diferencia constante entre las unidades teóricas de trastuzumab consumidas y las reales en una unidad de mezclas intravenosas. Métodos: se realizó un estudio del procedimiento completo manual y electrónico de la preparación de mezclas con trastuzumab mediante observación visual y revisión de los datos de control cuantitativo proporcionados por el sistema electrónico de preparación asistida y segura de la aplicación Farmis-Oncofarm ®. Resultados: se encontró diferencia entre el volumen óptimo del vial de trastuzumab que informa la ficha técnica del producto y el contenido en la ficha del medicamento de la aplicación. Además se encontró un defecto del volumen óptimo de las jeringas de 10 ml utilizadas en el proceso de reconstitución del vial. Conclusiones: el defecto de volumen óptimo de las jeringas de 10 ml utilizadas en el proceso de reconstitución es la causa del mayor número de viales reales consumidos en la preparación de mezclas con trastuzumab. Esto produce un impacto económico muy importante, estimando un sobrecoste anual de aproximadamente 46.508 €, sin provocar consecuencias negativas en el paciente.

Análisis causal e impacto de un error sistemático detectado en el consumo de trastuzumab / Causal analysis and impact of a systematic error detected about consumption associated with trastuzumab

Objetivo: determinar la causa de la diferencia constante entre las unidades teóricas de trastuzumab consumidas y las reales en una unidad de mezclas intravenosas. Métodos: se realizó un estudio del procedimiento completo manual y electrónico de la preparación de mezclas con trastuzumab mediante observación visual y revisión de los datos de control cuantitativo proporcionados por el sistema electrónico de preparación asistida y segura de la aplicación Farmis-Oncofarm. Resultados: se encontró diferencia entre el volumen óptimo del vial de trastuzumab que informa la ficha técnica del producto y el contenido en la ficha del medicamento de la aplicación. Además se encontró un defecto del volumen óptimo de las jeringas de 10 ml utilizadas en el proceso de reconstitución del vial. Conclusiones: el defecto de volumen óptimo de las jeringas de 10 ml utilizadas en el proceso de reconstitución es la causa del mayor número de viales reales consumidos en la preparación de mezclas con trastuzumab. Esto produce un impacto económico muy importante, estimando un sobrecoste anual de aproximadamente 46.508 Euros, sin provocar consecuencias negativas en el paciente (AU)

Objective: determine the cause of the constant difference between the theoretical and real number of trastuzumab units consumed in an Intravenous Mixtures Unit. Methods: was studied the manual and electronic full procedure about preparing mixtures with trastuzumab. Was performed by visual observation and review of quantitative monitoring data from the electronic preparation support and safe system of the application Farmis-Oncofarm. Results: difference between the optimum volume of trastuzumab contained in the summary of product characteristics and the same included in Farmis_Oncofarm was found. Also found a defect of the optimum volume of 10ml syringes used in the reconstitution vials process. Conclusions: the default in the optimal volume of 10ml syringes used in the reconstitution process increases the real consumed units of trastuzumab. This produces a significant economic impact calculated in an annual additional cost in approximately 46.508 Euros without negative consequences for the patient (AU)

Ciprofloxacin, but not levofloxacin, affects cyclosporine blood levels in a patient with pure red blood cell aplasia.

A 38-year-old man diagnosed with pure red blood cell aplasia was undergoing treatment with cyclosporine 200 mg/day. On day 41, the cyclosporine dose was increased to 250 mg/day. On day 45, the patient was hospitalized with fever, and ciprofloxacin 200 mg IV tid was begun. The level of cyclosporine was 297 ng/mL, which obliged us to reduce cyclosporine to 200 mg/day. On day 59, ciprofloxacin was discontinued. On day 80, the patient was hospitalized with fever, and levofloxacin 500 mg/d IV was begun. The patient was continued on cyclosporine 250 mg/day. On day 90, levofloxacin was discontinued. The cyclosporine dose-to-blood level ratio was maintained constant in subsequent controls. In this patient, the substantial and sustained increase in cyclosporine blood levels after ciprofloxacin was added to the patient's therapy and the decrease in cyclosporine blood levels after the withdrawal of ciprofloxacin suggest a potential interaction. Levofloxacin therapy could be a therapeutic alternative, although pharmacokinetic/pharmacodynamic studies should be conducted.

Photo-induced Stevens-Johnson syndrome due to sulfasalazine therapy.

OBJECTIVE: To report a case of photo-induced Stevens-Johnson Syndrome (SJS) due to sulfasalazine therapy. CASE SUMMARY: Photo-induced SJS associated with sulfasalazine therapy occurred in a 34-year-old white man diagnosed as having seronegative symmetrical polyarthritis with no predisposing factors. According to his medical record, the patient had received methotrexate, levofolinate calcium, deflazacort, and diclofenac sodium as needed. Two months prior to admission, methotrexate and diclofenac sodium were suspended and treatment with sulfasalazine was started. The patient presented to our emergency department because of severe erythema confined to sun-exposed areas; annular lesions on the extremities and the mucosa were affected. Nikolsky's sign was present. A skin biopsy was compatible with SJS, and the clinical diagnosis was SJS induced by sulfasalazine. Administration of sulfasalazine was suspended, which resulted in an improvement in the skin lesions and general state of health. The patient was discharged without further symptoms. DISCUSSION: The observed reaction to sulfasalazine was considered phototoxic, as lesions appeared like a burn rash reaction in sun-exposed areas when sulfasalazine treatment was started and the reaction progressed to SJS. It seems that there was a correlation between the time course of the reaction and the administration of sulfasalazine. An objective causality assessment revealed that the adverse effect was possible. CONCLUSIONS: To our knowledge, this is the first report of photo-induced SJS due to sulfasalazine therapy. Clinicians should be aware of this infrequent but severe reaction. If clinical evaluation leads to the suspicion of SJS, sulfasalazine should be discontinued immediately.

Adecuación de las formas farmacéuticas de dosificación de la terapia antirretroviral / Adequation of pharmaceutical formulation dosage in antiretroviral therapy

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