Estudio de adecuación a la ficha técnica de las prescripciones de trastuzumab en un hospital de tercer nivel / Study of compliance with prescription information sheet of trastuzumab prescriptions in a tertiary level hospital

Introducción El presente estudio comparó las condiciones reales de uso de trastuzumab en la práctica clínica con las descritas oficialmente en ficha técnica. Además, se midió el gasto asociado a su uso. Métodos Estudio observacional de prescripción-indicación de trastuzumab en un hospital de tercer nivel desde enero de 2006 hasta el 31 de diciembre de 2007. Se analizó si el uso de trastuzumab en la práctica clínica se adecuaba a ficha técnica en lo referente a: sobreexpresión del HER2, indicación (cáncer de mama), esquema de tratamiento, línea de tratamiento, dosis, frecuencia y número de ciclos. Para medir el gasto, se calculó el número total de miligramos utilizados y posteriormente se multiplicó por el precio por miligramo de venta del laboratorio más IVA. Resultados Todos los pacientes (n=77) usaron trastuzumab para cáncer de mama. El 62,6% de los pacientes presentó sobreexpresión del HER2+++. Se utilizaron 29 esquemas no autorizados en ficha técnica. El gasto total de trastuzumab durante el periodo de estudio fue de 1.537.622,73 euros. Conclusiones: Aunque el trastuzumab se utiliza siempre en cáncer de mama, se usa en condiciones distintas a las autorizadas en ficha técnica, tanto en lo referente a la sobreexpresión de HER2, como en los esquemas de tratamiento (AU)

Introduction This study compares trastuzumab's actual conditions of use in clinical practice with those officially described on its summary of product characteristics. We also measure the cost associated with its use. Methods Observational study of the prescription/indication of trastuzumab in a tertiary hospital from January 2006 to 31 December 2007. We analysed whether trastuzumab use in clinical practice complied with its summary of product characteristics, concerning the following: HER2 over expression, indication (breast cancer), treatment plan, line of treatment, dosage, frequency and number of cycles. To measure cost, we calculated the total number of milligrams used and then multiplied it by the laboratory's sale price per milligram plus VAT. Results All patients (n=77) used trastuzumab for breast cancer. Sixty-two point two percent of patients presented with HER2+++ over expression. Twenty-nine treatment plans were used, that were not authorised on the summary of product characteristics. The total trastuzumab cost during the study period was €1537 622.73. ConclusionsAlthough trastuzumab is always used for breast cancer, it is used in conditions other than those described on its summary of product characteristics, both for HER2 over expression and treatment plans (AU)

Study of compliance with prescription information sheet of trastuzumab prescriptions in a tertiary level hospital.

INTRODUCTION: This study compares trastuzumab's actual conditions of use in clinical practice with those officially described on its summary of product characteristics. We also measure the cost associated with its use. METHODS: Observational study of the prescription/indication of trastuzumab in a tertiary hospital from January 2006 to 31 December 2007. We analysed whether trastuzumab use in clinical practice complied with its summary of product characteristics, concerning the following: HER2 over expression, indication (breast cancer), treatment plan, line of treatment, dosage, frequency and number of cycles. To measure cost, we calculated the total number of milligrams used and then multiplied it by the laboratory's sale price per milligram plus VAT. RESULTS: All patients (n=77) used trastuzumab for breast cancer. Sixty-two point two percent of patients presented with HER2+++ over expression. Twenty-nine treatment plans were used, that were not authorised on the summary of product characteristics. The total trastuzumab cost during the study period was €1537 622.73. CONCLUSIONS: Although trastuzumab is always used for breast cancer, it is used in conditions other than those described on its summary of product characteristics, both for HER2 over expression and treatment plans.