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Trastuzumab emtansina (T-DM1) is an antibody-drug conjugate directed against the HER2 for the treatment of HER2+ mestastatic breast cancer (MBC), who has previously received trastuzumab plus a taxane. According to the results of the EMILIA trial versus lapatinib plus capecitabine T-DM1 shows an improvement in progression-free survival (PFS) and the overall survival (OS). It has a favorable profile reducing the incidence of grade 3-4 adverse reactions such as hand-foot syndrome and diarrhea. On the contrary increases significantly severe thrombocytopenia; bleeding risk and liver function should also be monitored. With the current import price T-DM1 has a cost per QALY of over 120,000 €. The price of the drug for the Spanish NHS has not yet been established. Drug cost would be the key factor in the sensitivity analysis and a 50% reduction in the price of the drug would place it close to the threshold of cost-effectiveness usually considered in our midst. According to the budget impact model used, a maximum of 1,218 patients / year and the budgetary impact throughout the Spanish state would be at € 70,490,850. In the initial analysis no advantage was found for T-DM1 in those patients without visceral involvement. Although a subsequent re-analysis of the results of PFS in which the definition of visceral involvement was specified a significant benefit was shown in this subgroup. We believe that this approach introduces a high degree of uncertainty, which does not guarantee the benefit achieved for this subgroup of patients.T-DM1 es un conjugado anticuerpo-farmaco dirigido contra el HER2 para el tratamiento del cancer de mama metastasico (CMM) HER2 +, que ha recibido previamente trastuzumab mas un taxano. De acuerdo con los resultados del ensayo EMILIA frente a lapatinib mas capecitabina T-DM1 muestra una mejora en la supervivencia libre de progresion (SLP) y la supervivencia global (SG). Tiene un perfil favorable reducir la incidencia de reacciones adversas grado 3-4 tales como el sindrome mano- pie y la diarrea. Sin embargo, aumenta significativamente el riesgo de trombocitopenia grave y debe monitorizarse el riesgo de hemorragia y la funcion hepatica. Con el precio de importacion actual T-DM1 tiene un coste por AVAC de mas de 120.000 €. El precio del farmaco para el Sistema Nacional de Salud en Espana aun no ha sido establecido. El precio del farmaco seria el factor clave en el analisis de sensibilidad y una reduccion del 50% en el precio lo situaria cerca del umbral de coste-efectividad generalmente considerada en nuestro medio como aceptable. De acuerdo con el modelo de impacto presupuestario utilizado, se trataria un maximo de 1.218 pacientes / ano y el impacto presupuestario de todo el estado espanol estaria entorno a 70.490.850 € para este volumen de pacientes. En el analisis inicial no se encontro ninguna ventaja para T-DM1 en aquellos pacientes sin afectacion visceral. Aunque un re-analisis posterior de los resultados de SLP en el que se especifica la definicion de la afectacion visceral se muestra un beneficio significativo en este subgrupo. Creemos que este enfoque presenta un alto grado de incertidumbre, y no garantiza el beneficio logrado para este subgrupo de pacientes.

El objetivo de este trabajo es demostrar que la existencia de los Comites de Etica de la Investigacion(CEIs) es congruente con el tiempo historico que nos ha tocado vivir. La idea de una ciencia neutra se remontaa la creacion de la Royal Society. Putnam y otros investigadores propusieron el termino de valoresepistemicos para los valores propios de la ciencia. A esta transformacion axiologica se le ha denominadode varias formas: modo 2 de conocimiento, ciencia postnormal, ciencia postacademica y tambien tecnociencia.No hay innovacion sin valoracion previa, e incluso sin multiples valoraciones previas. La existenciaactual de los Comites de Etica de la Investigacion (CEIs) es un hecho congruente con el desarrollohistorico de la epistemologia durante el siglo XX. Una de las funciones mas importantes de los CEIs, esla evaluacion axiologica (valores epistemicos) de los proyectos de investigacion.

Aim of the review To study the prevalence of drug interactions in hospital healthcare by reviewing literature. Method A review was carried out of studies written in Spanish and English on the prevalence of drug interactions in hospital care published in Pubmed between January 1990 and September 2008. The search strategy combined free text and MeSH terms, using the following keywords: “Drug interaction”, “prevalence” and “hospital”. For each article, we classified independent variables (pathology, age of population, whether patients were hospitalized or not, geographical location, etc.) and dependent variables (number of interactions per 100 patients studied, prevalence of patients with interactions, most common drug interactions, and others). Results The search generated 436 articles. Finally, 47 articles were selected for the study, 3 provided results about drug interactions with real clinical consequences, 42 about potential interactions, and 2 described both. The prevalence of patients with interactions was between 15 and 45 % and the number of interactions per 100 patients was between 37 and 106, depending on the group of studies analyzed. There was a considerable increase in these rates in patients with heart diseases and elderly persons. Conclusion There is a large number of studies on the prevalence of drug interactions in hospitals but they report widely varying results. The prevalence is higher in patients with heart diseases and elderly people.

Background The healthcare models developed for patients with multiple chronic diseases agree on the need for improving drug therapy in these patients. The issues of patient compliance, appropriateness of prescriptions and the reconciliation process are of vital importance for patients receiving multiple drug treatment. Objective To identify and select the most appropriate tools for measuring treatment compliance and appropriateness in multiple-disease patients, as well as the best reconciliation strategy. Methods The study used the Delphi methodology. We identified compliance and appropriateness questionnaires and scales, as well as functional organisation models for reconciliation that had been used in patients with multiple chronic conditions. Based on the strength of the evidence, their usefulness in these patients and ease of use, the panel selected the most appropriate ones. Results We selected 46 indications for the panel: 5 on compliance, 20 on appropriateness, and 31 on reconciliation. The tool considered most appropriate and with a high degree of agreement was the “Adherence to Refills and Medication Scale” questionnaire. For appropriateness, the Medication Appropriateness Index questionnaire was considered appropriate. The STOPP/START criteria were the most appropriate. The greatest degree of agreement regarding reconciliation was on the information that needed to be collected and the variables considered as discrepancies. Conclusions The “Adherence to Refills and Medication Scale” questionnaire for compliance, the STOPP/START criteria, the Medication Appropriateness Index questionnaire for appropriateness and the development of a specific strategy for reconciliation were considered appropriate for the assessment of drug therapy in patients with multiple chronic conditions.

identify by means of a survey the off-label treatments more often used in the oncohaematology area, as well as to know the established procedures and criteria used to authorise those treatments.a four-section survey was designed: 1) demographic data and hospital activity, 2) Off-label treatments protocol, 3) Approval criteria and 4) Off-label oncology treatments conducted during the last year.in 42.1% of the hospitals it's needed an authorisation before dispensing in more tan 80% of the treatments. The most influential factor in the approval-dispensation system is the available evidence. The consent of the hospital management with previous Pharmacy department's report was the most common authorisation procedure. 55.3% of the hospitals settled specific patient criteria to help the decision-making altogether with the available safety and efficacy data of the drug for the requested indication. In most centers a lower level of evidence is accepted if there are no therapeutic alternatives as well as in tumors of low prevalence. Most of the centers have not clearly established a criterion of effectiveness to consider a benefit as clinically relevant, nor the cost-effectiveness threshold for approving a FFT.there is a great variability in the off-label treatments use and also in the criteria used for its approval.Objetivo: identificar mediante una encuesta los tratamientos fuera de la ficha tecnica (FFT) que mas frecuentemente se utilizan en el area de oncohematologia. Conocer los procedimientos y criterios que se han establecido para autorizar estos tratamientos. Método: se diseno una encuesta con cuatro secciones: 1) datos demograficos y de actividad del hospital, 2) procedimiento de utilizacion de medicamentos FFT, 3) criterios de aprobacion y 4) tratamientos oncologicos FFT tramitados durante el ano anterior. Resultados: en el 42,1% de los centros la proporcion en la que es necesaria autorizacion previa a la dispensacion es mayor del 80%. El factor mas importante que influye en el circuito de autorizacion-dispensacion de estos farmacos es la evidencia disponible. El procedimiento de autorizacion mas habitual es la autorizacion de la direccion del hospital previo informe del servicio de farmacia. En un 55,3% de los hospitales se han establecido criterios especificos del paciente que ayudan a la toma de decisiones, junto con los aspectos de eficacia y seguridad de los farmacos en la indicacion solicitada. En la mayoria de los centros se acepta un menor nivel de evidencia en el caso de que no existan alternativas terapeuticas, asi como en los tumores de baja prevalencia. La mayor parte de los centros no tienen claramente establecido un criterio de eficacia para considerar un beneficio como clinicamente relevante, y tampoco el umbral coste-eficacia para aprobar un FFT. Conclusiones: existe una gran variabilidad en el procedimiento de utilizacion de los FFT y en los criterios que se utilizan para su aprobacion.

Background The place of monoclonal antibodies in metastatic colorectal cancer has not been clearly defined. Objective To determine the treatment pattern of monoclonal antibodies in colorectal cancer patients in the Andalusian Public Healthcare System. Method Data were collected from all patients treated with these drugs from July 2009 to December 2010 from pharmacy programs and medical records. Results Three hundred patients were included, of whom 227 received the antibody at the forefront. The proportion of patients who received bevacizumab in the first line is greater than that of cetuximab (62.1 vs. 37.5 % respectively) and similar in the second line and subsequent (47.8 vs. 53.8 % and 48.5 vs. 46.2 % respectively). XELOXbevacizumab was the most frequently prescribed scheme (35.3 %) followed by FOLFOX-monoclonal antibody schemes, regardless that this was bevacizumab or cetuximab (22.5 %). The median progression free survival (PFS) was 11.7 months for patients receiving cetuximab, 9.6 months for patients receiving bevacizumab and 8.2 months for those who received no monoclonal antibody in the first line. Conclusion Bevacizumab was the antibody of choice in first line, showing utilization rates similar to cetuximab in second line and subsequent. The median PFS in our study is related to the PFS of the major clinical trials.