Estudio de adecuación a la ficha técnica de las prescripciones de trastuzumab en un hospital de tercer nivel

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 D1537 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.