Real life study of sacubitril valsartan combined therapy in chronic heart failure / Estudio en vida real de la terapia combinada de sacubitril valsartán en insuficiencia cardíaca crónica

Objectives: Sacubitril/valsartan is a drug for chronic heart failure (CHF), approved by Drugs Regulatory Agencies based on the results of the PARADIGM-HF, which could have several limitations on internal validity and applicability. Furthermore, this drug has a high economic impact. The objectives of this study are to evaluate effectiveness and safety of sacubitril/valsartan in CHF, as well as to evaluate adequation to use criteria stablished in a Health Management Area (HMA). Methods: Retrospective, observational study including adult patients with CHF who were receiving sacubitril/valsartan during 2017 in an HMA. The treatment effectiveness was assesed by death and/or hospitalization rates related to CHF. Frequency of adverse events was used to safety evaluation. Furthermore, adequation rate was assessed. Findings: A total of 68 patients were included. Death or hospitalization rates due to CHF at 12 months were 32.3% globally (2.9% and 29.4% respectively). Among patients analyzed, 33.8% presented hypotension, during the first year after treatment initiation. Overall adequation rate was 67.6%. Conclusions: A high percentage of death and/or hospitalization due to CHF was observed. Hypotension is a frequent adverse event which leads to dose adjustment and/or drug withdrawal. Overall adequation rate of sacubitril/valsartan prescription is acceptable. (AU)

Objetivos: El sacubitril/valsartán es un medicamento para la insuficiencia cardíaca crónica (ICC), aprobado por las agencias reguladoras de medicamentos en base a los resultados del ensayo pivotal PARADIGM-HF, que podría tener varias limitaciones en la validez interna y la aplicabilidad. Además, este fármaco tiene un alto impacto económico. Los objetivos de este estudio son evaluar la efectividad y la seguridad de sacubitril/valsartán en la ICC, así como evaluar la adecuación a los criterios establecidos en un Área de Gestión de Salud (AGS). Métodos: Estudio observacional retrospectivo que incluye pacientes adultos con ICC que recibieron sacubitril/valsartán durante 2017 en una AGS. La efectividad del tratamiento fue evaluada mediante la tasa de mortalidad y/o hospitalización relacionadas con la ICC. La frecuencia de los eventos adversos se utilizó para la evaluación de seguridad. Además, se evaluó la tasa de adecuación. Resultados: Se incluyeron un total de 68 pacientes. Las tasas de mortalidad u hospitalización por ICC a los 12 meses fueron del 32,3% a nivel global (2,9% y 29,4%, respectivamente). Entre los pacientes analizados, el 33,8% presentó hipotensión durante el primer año después del inicio del tratamiento. La tasa de adaptación global fue del 67,6%. Conclusiones: Se observó un alto porcentaje de muerte y/o hospitalización por ICC. La hipotensión es un evento adverso frecuente que conduce al ajuste de la dosis y/o a la retirada del medicamento. La tasa general de adecuación de la prescripción de sacubitril/valsartán es aceptable. (AU)

A multidisciplinary intervention to reduce potential prescription problems related to kidney damage in chronic patients / Intervención multidisciplinar para reducir los posibles problemas de prescripción relacionados con el daño renal en pacientes crónicos

Objectives: Andalusian Health Service (AHS) established the RP4 program, based on the review of potential prescription problems (PPPs) in order to improve patient’s safety. Some of these PPPs are related to kidney damage (PPPKDs). The main objective of this study is to evaluate the percentage of acceptance of the pharmaceutical intervention (PI) developed in a Health Management Area (HMA) for reducing PPPKDs. We also aimed to describe these PPPKDS and to analyze the evolution of these data between 2015-2019. Methods: Retrospective study conducted by the Pharmacy Service of an HMA which offers health coverage to 406,768 patients. All the PPPKDs detected in these patients were included. Data were collected through an AHS Web Application. A descriptive analysis of variables was developed. Results: In 2019, 466 PPPKDs (involving 460 patients) were detected. Overall percentage of acceptance of the PI was 90.7% and, according to type of PPPKD, was: 92.8% for NSAIDs duplication, 90.7% for double renin-angiotensin-aldosterone system (RAAS) blockade and 89.8% for triple Whammy. During 2015-2019, detected PPPKDs have decreased from 634 to 466, and the percentage of acceptance has been adequate every year. Conclusion: The acceptance of the PI, framed in the RP4 program, was optimal. The number of PPPKDs detected has decreased and the percentage of acceptance has remained elevated during the study period, which would support the utility of this program for the improvement of patients’ safety. (AU)

Objetivos: El Sistema Andaluz de Salud (SAS) estableció el programa RP4, basado en la revisión de potenciales problemas de prescripción (PPPs) a fin de mejorar la seguridad de los pacientes. Algunos de los PPPs están relacionados con el daño renal (PPPKDs). El objetivo principal de este estudio es evaluar el porcentaje de aceptación de la intervención farmacéutica (PI) llevada a cabo en un Área de Gestión Sanitaria (HMA) para reducir los PPPKDs. Otros objetivos son describir estos PPPKDs y analizar la evolución de estos datos entre 2015-2019. Métodos: Estudio retrospectivo desarrollado por el Servicio de Farmacia de un HMA que ofrece atención sanitaria a 406.768 pacientes. Todos los PPPKDs detectados en estos pacientes se incluyeron. Los datos se rcogieron a través de una aplicación web del SAS. Se realizó un análisis descriptivo de las variables. Resultados: En 2019, se detectaron 466 PPPKDs (involucrando a 460 pacientes). El porcentaje global de aceptación de la PI fue del 90,7% y, según el tipo de PPPKD, fue: 92,8% para la duplicidad de AINEs, el 90,7% para el doble bloqueo del eje renina-angiotensina-aldosterona (RAAS) y del 89,7% para la triple Whammy. Durante 2015-2019, los PPPKDs detectados han descendidio de 634 a 466 y el porcentaje de aceptación ha sido adecuado cada año. Conclusión: La aceptación de la PI, enmarcada en el programa RP4, ha sido óptima. El número de PPPKDs detectado ha descendido y el porcentaje de aceptación se ha mantenido elevado durante el periodo de estudio, lo que podría avalar la utilidad de este programa para mejorar la seguridad de los pacientes. (AU)

The relative clinical efficacy of trametinib-dabrafenib and cobimetinib-vemurafenib in advanced melanoma: an indirect comparison.

WHAT IS KNOWN AND OBJECTIVE: Melanoma causes the majority of skin cancer-related deaths. The outcome of melanoma depends on its stage at diagnosis. Currently, for patients with advanced melanoma, two MEK inhibitors (trametinib and cobimetinib) have been authorized by the European Medicines Agency. The main objective of this study was to compare the relative efficacy of trametinib-dabrafenib and cobimetinib-vemurafenib in patients with advanced melanoma through adjusted indirect treatment comparisons (ITCs). METHODS: A search was made up to the 3rd of November 2015. Databases consulted were MEDLINE, the Cochrane Library and the Centre for Reviews and Dissemination. Randomized controlled trials (RCTs) which compared the efficacy of trametinib-dabrafenib or cobimetinib-vemurafenib versus a common treatment comparator, in which outcomes of overall survival, progression-free survival (PFS) and overall response rate (ORR) were considered. ITCs were carried out using the method proposed by Bucher et al. RESULTS AND DISCUSSION: Two RCTs were included (one for each drugs combination). The results of the adjusted ITCs showed that there were no statistically significant differences between the two combinations in terms of PFS and ORR. WHAT IS NEW AND CONCLUSION: The ITCs indicate no difference in efficacy between both treatments. However, there should be an independent, head-to-head trial of both combinations to confirm the results.

Indirect comparison for Anti-TNF drugs in moderate to severe ulcerative colitis / Fármacos anti-TNF en colitis ulcerosa moderada-grave: comparación indirecta

Objective: To compare the relative efficacy of infliximab, adalimumab and golimumab through adjusted indirect treatment comparisons (ITCs). Methods: An exhaustive search was performed until October 2013. Databases consulted were MEDLINE, EMBASE, the Cochrane Library, the Centre for Reviews and Dissemination and the Web of Science. Randomized control trials (RCTs) comparing the efficacy of infliximab, adalimumab or golimumab versus placebo, in terms of clinical remission, clinical response and mucosal healing, were included. In the case that more than one RCT fulfilled the inclusion criteria for the same drug, a metanalysis was undertaken using a fixed effects model. ITCs were carried out using the method proposed by Bucher et al. Results: 6 RCTs published in 5 papers were included: 2 for infliximab (ACT 1 and ACT 2), 2 for adalimumab (ULTRA 1 y ULTRA 2) and 2 for golimumab (PURSUIT-SC y PURSUIT-M).In these RTCs, each biological agent was superior in efficacy to placebo. The results of the adjusted ITC are the following. In relation to the clinical remission, in the induction and maintenance period, there are no statistically significant differences between the three anti-TNF drugs. In relation to the clinical response and mucosal healing, in the induction period, there are statistically significant differences between infliximab and adalimumab. Conclusion: In view of the results obtained, infliximab, adalimumab and golimumab appear to be similarly effective the rapeutic alternatives. Therefore, other considerations such as safety, tolerance and cost-effectiveness should be taken into account in order to select the most appropriate treatment (AU)

Objetivo: Comparar la eficacia relativa de infliximab, adalimumab y golimumab mediante comparaciones indirectas (CI) ajustadas. Métodos: Se realizó una búsqueda bibliográfica que abarcó hasta Octubre 2013. Las bases de datos consultadas fueron: MEDLINE, EMBASE, the Cochrane Library, the Centre for Reviews and Dissemination y the Web of Science. Se incluyeron ensayos clínicos aleatorizados (ECA) que compararan la eficacia de infliximab, adalimumab o golimumab frente a placebo en términos de remisión clínica, respuesta clínica y curación de la mucosa. En el caso de que se incluyera más de un ECA para un mismo fármaco se llevó a cabo un metanálisis utilizado el modelo de efectos fijos. Las CI se realizaron utilizando el mé- todo de Butcher et al. Resultados: Se incluyeron 6 ECA publicados en 5 artículos: 2 para infliximab (ACT 1 y ACT 2), 2 para adalimumab (ULTRA 1 y ULTRA 2) y 2 para golimumab (PURSUIT-SC y PURSUIT-M). Los tres agentes biológicos presentaron mayor eficacia que placebo. Los resultados de las CI fueron los siguientes: en relación a la remisión clínica, en el período de inducción y en el período de mantenimiento, no hubo diferencias estadísticamente significativas entre los tres fármacos anti-TNF. En relación a la respuesta clínica y a la curación de la mucosa, en el período de inducción hay diferencias estadísticamente significativas entre infliximab y adalimumab. Conclusiones: En base a los resultados obtenidos (eficacia similar), infliximab, adalimumab y golimumab parecen ser alternativas terapéuticas. Así, otras consideraciones como la seguridad, la tolerancia y el coste-efectividad deben considerarse a la hora de seleccionar el tratamiento más adecuado (AU)

Indirect comparison for Anti-TNF drugs in moderate to severe ulcerative colitis.

OBJECTIVE: To compare the relative efficacy of infliximab, adalimumab and golimumab through adjusted indirect treatment comparisons (ITCs). METHODS: An exhaustive search was performed until October 2013. Databases consulted were MEDLINE, EMBASE, the Cochrane Library, the Centre for Reviews and Dissemination and the Web of Science. Randomized control trials (RCTs) comparing the efficacy of infliximab, adalimumab or golimumab versus placebo, in terms of clinical remission, clinical response and mucosal healing, were included. In the case that more than one RCT fulfilled the inclusion criteria for the same drug, a metanalysis was undertaken using a fixed effects model. ITCs were carried out using the method proposed by Bucher et al. RESULTS: 6 RCTs published in 5 papers were included: 2 for infliximab (ACT 1 and ACT 2), 2 for adalimumab (ULTRA 1 y ULTRA 2) and 2 for golimumab (PURSUIT-SC y PURSUIT-M).In these RTCs, each biological agent was superior in efficacy to placebo. The results of the adjusted ITC are the following. In relation to the clinical remission, in the induction and maintenance period, there are no statistically significant differences between the three anti-TNF drugs. In relation to the clinical response and mucosal healing, in the induction period, there are statistically significant differences between infliximab and adalimumab. CONCLUSION: In view of the results obtained, infliximab, adalimumab and golimumab appear to be similarly effective therapeutic alternatives. Therefore, other considerations such as safety, tolerance and cost-effectiveness should be taken into account in order to select the most appropriate treatment.

Objetivo: Comparar la eficacia relativa de infliximab, adalimumab y golimumab mediante comparaciones indirectas (CI) ajustadas. Métodos: Se realizó una búsqueda bibliográfica que abarcó hasta Octubre 2013. Las bases de datos consultadas fueron: MEDLINE, EMBASE, the Cochrane Library, the Centre for Reviews and Dissemination y the Web of Science. Se incluyeron ensayos clínicos aleatorizados (ECA) que compararan la eficacia de infliximab, adalimumab o golimumab frente a placebo en términos de remisión clínica, respuesta clínica y curación de la mucosa. En el caso de que se incluyera más de un ECA para un mismo fármaco se llevó a cabo un metanálisis utilizado el modelo de efectos fijos. Las CI se realizaron utilizando el método de Butcher et al. Resultados: Se incluyeron 6 ECA publicados en 5 artículos: 2 para infliximab (ACT 1 y ACT 2), 2 para adalimumab (ULTRA 1 y ULTRA 2) y 2 para golimumab (PURSUIT-SC y PURSUIT-M). Los tres agentes biológicos presentaron mayor eficacia que placebo. Los resultados de las CI fueron los siguientes: en relación a la remisión clínica, en el período de inducción y en el período de mantenimiento, no hubo diferencias estadísticamente significativas entre los tres fármacos anti-TNF. En relación a la respuesta clínica y a la curación de la mucosa, en el período de inducción hay diferencias estadísticamente significativas entre infliximab y adalimumab. Conclusiones: En base a los resultados obtenidos (eficacia similar), infliximab, adalimumab y golimumab parecen ser alternativas terapéuticas. Así, otras consideraciones como la seguridad, la tolerancia y el coste-efectividad deben considerarse a la hora de seleccionar el tratamiento más adecuado.

Factors related with the appropriateness of pharmacological treatment in polypathological patients.

OBJECTIVE: To evaluate the association between the number of pharmacological inappropriateness and possible factors related with it. METHODS: All polyphatological patients of the IMPACTO project in a tertiary hospital were included (July 2010-March 2012). The pharmacist performed the interventions based on a combined strategy that included the modified MAI and the STOPP-START criteria. A greater number of interventions indicated smaller treatment appropriateness. In the analysis of the strength of association between two continuous variables the Pearson correlation coefficient was used. Test of Student's t or Mann-Whitney comparisons of quantitative data between two groups were applied. Subsequently, a multivariate analysis was performed to study possible variables which explain the inappropriateness of the pharmacological treatment. RESULTS: 242 patients were included. 838 inappropriateness were detected (average per patient of 3±2). The appropriateness was associated with: number of diagnoses, medications, and categories of polypathology, Charlson Comorbidity Index, sex, and categories A1 and B2. When diagnosing collinearity in the multivariate model, we observed that there was collinearity between "Charlson Comorbidity Index" and "number of categories of polypathological patients", so it was decided to conduct two multivariate models variables, one each. The number of drugs, the number of diagnoses and the gender remained significant in both multivariate models. CONCLUSIONS: The appropriateness of pharmacological treatment decreases with increasing number of drugs and number of diagnoses, as well as female gender. However, both multi variate models explain a low percentage of variability in the number of inappropriateness.

Objetivo: evaluar la asociación entre el número de inadecuaciones farmacológicas y posibles factores relacionados con la misma. Métodos: : Se incluyeron todos los pacientes pluripatológicos del proyecto IMPACTO en un hospital de tercer nivel (Julio 2010-Marzo 2012). El farmacéutico realizó las intervenciones en base a una estrategia combinada que incluía el MAI modificado y los criterios STOPP-START. A mayor número de intervenciones menor adecuación del tratamiento. En los análisis de la fuerza de asociación entre dos variables continuas se utilizó el coeficiente de correlación de Pearson. Se aplicó el test de la t de Student o U de Mann-Whitney en comparaciones de datos cuantitativos entre dos grupos. Posteriormente, se realizó un análisis multivariante, para estudiar posibles variables que explicasen las inadecuaciones del tratamiento farmacológico. Resultados: Se incluyeron un total de 242 pacientes. Se detectaron un total de 838 inadecuaciones, siendo la media por paciente de 3±2. La adecuación del tratamiento farmacológico se asoció con el número de diagnósticos, el número de medicamentos, el número de categorías de paciente pluripatológico, el índice de comorbilidad de Charlson, el sexo y las categorías A1 y B2. Al realizar el diagnóstico de colinealidad, en el modelo multivariante, de las variables se observó que existía colinealidad entre las variables "índice de comorbilidad de Charlson" y "número de categorías de paciente pluripatológico", por lo que se decidió realizar dos modelos multivariantes, uno con cada una de ellas. Se mantuvieron significativos con el multivariante y para ambos modelos el número de medicamentos, el número de diagnósticos y el sexo. Conclusiones: La adecuación del tratamiento farmacológico disminuyó al aumentar el número de medicamentos y el número de diagnósticos, así como en mujeres. No obstante, ambos modelos multivariantes, explicaron un porcentaje de variabilidad del número de inadecuaciones leve.

Factors related with the appropriateness of pharmacological treatment in polypathological patients / Factores relacionados con la adecuación del tratamiento farmacológico en pacientes pluripatológicos

Objective: To evaluate the association between the number of pharmacological inappropriateness and possible factors related with it. Methods: All polyphatological patients of the IMPACTO project in a tertiary hospital were included (July 2010-March 2012). The pharmacist performed the interventions based on a combined strategy that included the modified MAI and the STOPP-START criteria. A greater number of interventions indicated smaller treatment appropriateness. In the analysis of the strength of association between two continuous variables the Pearson correlation coefficient was used. Test of Student’s t or Mann-Whitney comparisons of quantitative data between two groups were applied. Subsequently, a multivariate analysis was performed to study possible variables which explain the inappropriateness of the pharmacological treatment. Results: 242 patients were included. 838 inappropriateness were detected (average per patient of 3±2). The appropriateness was associated with: number of diagnoses, medications, and categories of polypathology, Charlson Comorbidity Index, sex, and categories A1 and B2. When diagnosing collinearity in the multivariate model, we observed that there was collinearity between «Charlson Comorbidity Index» and «number of categories of polypathological patients», so it was decided to conduct two multivariate models variables, one each. The number of drugs, the number of diagnoses and the gender remained significant in both multivariate models. Conclusions: The appropriateness of pharmacological treatment decreases with increasing number of drugs and number of diagnoses, as well as female gender. However, both multivariate models explain a low percentage of variability in the number of inappropriateness (AU)

Objetivo: evaluar la asociación entre el número de inadecuaciones farmacológicas y posibles factores relacionados con la misma. Métodos: Se incluyeron todos los pacientes pluripatológicos del proyecto IMPACTO en un hospital de tercer nivel (Julio 2010-Marzo 2012). El farmacéutico realizó las intervenciones en base a una estrategia combinada que incluía el MAI modificado y los criterios STOPP-START. A mayor número de intervenciones menor adecuación del tratamiento. En los análisis de la fuerza de asociación entre dos variables continuas se utilizó el coeficiente de correlación de Pearson. Se aplicó el test de la t de Student o U de Mann-Whitney en comparaciones de datos cuantitativos entre dos grupos. Posteriormente, se realizó un análisis multivariante, para estudiar posibles variables que explicasen las inadecuaciones del tratamiento farmacológico. Resultados: Se incluyeron un total de 242 pacientes. Se detectaron un total de 838 inadecuaciones, siendo la media por paciente de 3±2. La adecuación del tratamiento farmacológico se asoció con el número de diagnósticos, el número de medicamentos, el número de categorías de paciente pluripatológico, el índice de comorbilidad de Charlson, el sexo y las categorías A1 y B2. Al realizar el diagnóstico de colinealidad, en el modelo multivariante, de las variables se observó que existía colinealidad entre las variables «índice de comorbilidad de Charlson» y «número de categorías de paciente pluripatológico», por lo que se decidió realizar dos modelos multivariantes, uno con cada una de ellas. Se mantuvieron significativos con el multivariante y para ambos modelos el número de medicamentos, el número de diagnósticos y el sexo. Conclusiones: La adecuación del tratamiento farmacológico disminuyó al aumentar el número de medicamentos y el número de diagnósticos, así como en mujeres. No obstante, ambos modelos multivariantes, explicaron un porcentaje de variabilidad del número de inadecuaciones leve (AU)

Assessment of new drugs in a tertiary hospital using a standardized tool.

OBJECTIVE: To describe the profile of new drugs evaluated by the Pharmacy and Therapeutics committee in a tertiary hospital using a standardized tool, the Guideline for the Introduction of New Drugs in the Formulary (GINF form), as main objective. MATERIALS AND METHODS: Retrospective observational study of drugs was assessed during 2008-2011. Variables related to the drug, the request, and the result of the evaluation were collected based on information contained in the GINF form and in the assessment reports. RESULTS: 63 of 75 assessed drugs (84%) were included in the hospital formulary. Only one drug (1%) was included without any restrictions. The rest of them were included as therapeutic equivalents (23%) or under specific recommendations (61%). Half of the drugs (6) not included had insufficient evidence of effectiveness compared with current treatments. Haematology and Medical Oncology were found to be the most active medical services in the application process. There was a high prevalence of drugs that had more than one advanced clinical trial (phase III and/or phase IV). Furthermore, 28% of assessed drugs were associated with a financial burden of more than ?10,000 per year for our hospital. Highquality information was provided by applicants to the P&T committee for drugs that were finally included. However, the relationship between the information provided to the P&T committee and its decision was not statistical significance. CONCLUSION: The requests received were primarily related to drugs intended for parenteral use and most of them were antineoplastic drugs. The medical departments most heavily represented were Haematology and Oncology.

Objetivo: Describir las características de los nuevos fármacos evaluados por la Comisión de Farmacia y Terapéutica (CFyT) en un hospital terciario mediante el empleo de una herramienta normalizada, la Guía para la valoración de Inclusión de Nuevos Fármacos, como objetivo principal. Material y métodos: Estudio observacional retrospectivo de aquellos fármacos evaluados en el periodo 2008-11. Fueron recogidas variables relativas al fármaco, a la solicitud y al resultado final de la evaluación mediante la información contenida en las guías GINF y en los informes finales de evaluación. Resultados: De los 75 medicamentos evaluados, 63 (84%) fueron incluidos en la Guía Farmacoterapéutica del Hospital. Únicamente 1 (1,3%) lo fue sin ningún tipo de restricción. El resto fueron incluidos como equivalentes terapéuticos (21,3%) o bajo recomendaciones específicas (61,3%). La mitad de los fármacos no incluidos (6) presentaban insuficiente evidencia respecto a su eficacia frente a los tratamientos habituales. Hematología y Oncología Médica se encontraron entre los servicios médicos más activos en la solicitud. Se observó un alto porcentaje de fármacos que disponían de más de un ensayo clínico en fase avanzada (III y/o IV). Por otra parte, el 28% de los fármacos evaluados se relacionaron con un impacto financiero superior 10.000 ??anuales. Las guías GINF proporcionadas por los solicitantes a la CFyT se caracterizaron por la alta calidad de la información contenida en ellas. Sin embargo, la relación entre la información proporcionada a la CFyT y la decisión final de la misma no fue estadísticamente significativa. Conclusiones: Las solicitudes recibidas pertenecieron principalmente a fármacos de administración parenteral, siendo la mayor parte de ellos antineoplásicos. Los servicios médicos más intensamente representados fueron Hematología y Oncología.

[Visa at a tertiary hospital]. / El visado en un hospital de tercer nivel.

OBJECTIVE: To analyze the visa application process and his activity at a tertiary hosipital. MATERIAL AND METHODS: Descriptive study of the drug s visa activity during the period April 2011-April 2012. We designed a database and defined categories on the study variables: patients and recipes. For patients admitted to the Visa Unit, issues detected were recorded based on a previously established classification. RESULTS: 6738 patients were included. They involved the visa of 8,465 recipes. The visa was applied to 170 drugs and nutrition products different, being the majority Tacrolimus. During this period, we detected a total of 420 incidents being the most frequent «No clinical document¼ (46.67%) and the «Formal completion errors¼ (28.57%). CONCLUSIONS: This work has allowed a more detailed analysis of the activity, the types of incidents and the identification of areas for improvement.

Objetivo: Analizar el procedimiento de visado y su actividad en un hospital de tercer nivel. Material y métodos: Estudio descriptivo del procedimiento de visado durante el período abril 2011-abril 2012. Se diseñó una base de datos y se definieron categorías relativas a las variables de estudio: pacientes y recetas. Para los pacientes atendidos en la Unidad de Visado se registraron las incidencias detectadas en base a una clasificación previamente establecida. Resultados: Se incluyeron 6.738 pacientes (8.465 recetas visadas). Se visaron 170 medicamentos y productos de nutrición diferentes, siendo el mayoritario Tacrolimus. Se detectaron un total de 420 incidencias, siendo las más frecuentes la «Ausencia de documento clínico¼ (46,67 %) y los «Errores formales de cumplimentación¼ (28,57%). Conclusiones: El presente trabajo ha permitido un conocimiento más pormenorizado de la actividad, los tipos de incidencias y la identificación de áreas de mejora.

Assessment of new drugs in a tertiary hospital using a standardized tool

OBJECTIVE: To describe the profile of new drugs evaluated by the Pharmacy and Therapeutics committee in a tertiary hospital using a standardized tool, the Guideline for the Introduction of New Drugs in the Formulary (GINF form), as main objective. MATERIALS AND METHODS: Retrospective observational study of drugs was assessed during 2008-2011. Variables related to the drug, the request, and the result of the evaluation were collected based on information contained in the GINF form and in the assessment reports. RESULTS: 63 of 75 assessed drugs (84%) were included in the hospital formulary. Only one drug (1%) was included without any restrictions. The rest of them were included as therapeutic equivalents (23%) or under specific recommendations (61%). Half of the drugs (6) not included had insufficient evidence of effectiveness compared with current treatments. Haematology and Medical Oncology were found to be the most active medical services in the application process. There was a high prevalence of drugs that had more than one advanced clinical trial (phase III and/or phase IV). Furthermore, 28% of assessed drugs were associated with a financial burden of more than €10,000 per year for our hospital. High-quality information was provided by applicants to the P&T committee for drugs that were finally included. However, the relationship between the information provided to the P&T committee and its decision was not statistical significance. CONCLUSION: The requests received were primarily related to drugs intended for parenteral use and most of them were antineoplastic drugs. The medical departments most heavily represented were Haematology and Oncology

OBJETIVO: Describir las características de los nuevos fármacos evaluados por la Comisión de Farmacia y Terapéutica (CFyT) en un hospital terciario mediante el empleo de una herramienta normalizada, la Guía para la valoración de Inclusión de Nuevos Fármacos, como objetivo principal. MATERIAL Y MÉTODOS: Estudio observacional retrospectivo de aquellos fármacos evaluados en el periodo 2008-11. Fueron recogidas variables relativas al fármaco, a la solicitud y al resultado final de la evaluación mediante la información contenida en las guías GINF y en los informes finales de evaluación. RESULTADOS: De los 75 medicamentos evaluados, 63 (84%) fueron incluidos en la Guía Farmacoterapéutica del Hospital. Únicamente 1 (1,3%) lo fue sin ningún tipo de restricción. El resto fueron incluidos como equivalentes terapéuticos (21,3%) o bajo recomendaciones específicas (61,3%). La mitad de los fármacos no incluidos (6) presentaban insuficiente evidencia respecto a su eficacia frente a los tratamientos habituales. Hematología y Oncología Médica se encontraron entre los servicios médicos más activos en la solicitud. Se observó un alto porcentaje de fármacos que disponían de más de un ensayo clínico en fase avanzada (III y/o IV). Por otra parte, el 28% de los fármacos evaluados se relacionaron con un impacto financiero superior 10.000 € anuales. Las guías GINF proporcionadas por los solicitantes a la CFyT se caracterizaron por la alta calidad de la información contenida en ellas. Sin embargo, la relación entre la información proporcionada a la CFyT y la decisión final de la misma no fue estadísticamente significativa. CONCLUSIONES: Las solicitudes recibidas pertenecieron principalmente a fármacos de administración parenteral, siendo la mayor parte de ellos antineoplásicos. Los servicios médicos más intensamente representados fueron Hematología y Oncología

El visado en un hospital de tercer nivel / Visa at a tertiary hospital

Objetivo: Analizar el procedimiento de visado y su actividad en un hospital de tercer nivel. Material y métodos: Estudio descriptivo del procedimiento de visado durante el período abril 2011-abril 2012. Se diseñó una base de datos y se definieron categorías relativas a las variables de estudio: pacientes y recetas. Para los pacientes atendidos en la Unidad de Visado se registraron las incidencias detectadas en base a una clasificación previamente establecida. Resultados: Se incluyeron 6.738 pacientes (8.465 recetas visadas). Se visaron 170 medicamentos y productos de nutrición diferentes, siendo el mayoritario Tacrolimus. Se detectaron un total de 420 incidencias, siendo las más frecuentes la "Ausencia de documento clínico" (46,67 %) y los "Errores formales de cumplimentación" (28,57%).Conclusiones: El presente trabajo ha permitido un conocimiento más pormenorizado de la actividad, los tipos de incidencias y la identificación de áreas de mejora (AU)

Objective: To analyze the visa application process and his activity at a tertiary hosipital. Material and methods: Descriptive study of the drug s visa activity during the period April 2011-April 2012. We designed a database and defined categories on the study variables: patients and recipes. For patients admitted to the Visa Unit, issues detected were recorded based on a previously established classification. Results: 6738 patients were included. They involved the visa of 8,465 recipes. The visa was applied to 170 drugs and nutrition products different, being the majority Tacrolimus. During this period, we detected a total of 420 incidents being the most frequent "No clinical document" (46.67%) and the "Formal completion errors" (28.57%).Conclusions: This work has allowed a more detailed analysis of the activity, the types of incidents and the identification of areas for improvement (AU)

Biological treatments for moderate-to-severe psoriasis: indirect comparison.

WHAT IS KNOWN AND OBJECTIVE: Psoriasis is a chronic skin disease for which there is an increasing range of treatment options. Biological agents (ustekinumab, adalimumab, infliximab and etanercept) are indicated for moderate-to-severe plaque-type psoriasis in adults who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA Unfortunately, with new drugs, the pivotal trials leading to their licensing are often placebo-controlled trials rather than comparative trials vs. established therapies. Therefore, inference on comparative effectiveness of the newer agents must be derived indirectly, through estimation of effects of the new agents vs. a common comparator. The objective of this study is to compare the relative efficacy of the biological agents through a systematic review of the indirect clinical trial evidence. METHODS: A systematic literature search was performed for clinical trials of biological agents in psoriasis. Pivotal, randomized, double-blind, controlled (placebo) trials using intention-to-treat analysis were selected for detailed analysis. Trials must include PASI 75 as a primary end point. The indirect comparison was performed using the method of Bucher adjusted with the ITC calculator (Indirect Treatment Comparisons of the Canadian Agency for Drugs and Technologies in Health), etanercept being the reference drug. We defined delta value for therapeutic equivalence as a difference in the efficacy of 25% among the different treatment options. RESULTS AND DISCUSSION: Fourteen studies (four for ustekinumab, three for adalimumab, three for infliximab and four for etanercept) were included. The indirect comparison results reveal that ustekinumab, adalimumab and infliximab were statistically superior to etanercept with an absolute risk difference for PASI 75 of 12% (95% CI = 5·9-18%), 11% (95% CI = 5·3-16·7%) and 24% (29·7-18·3%) respectively. However, in all situations, the 95% confidence interval does not achieve clinical relevance as no delta exceeds the previously set value (25%). WHAT IS NEW AND CONCLUSION: Ustekinumab, adalimumab, infliximab and etanercept can be regarded as clinical equivalents for the treatment of psoriasis. Choice between these agents therefore depends on their relative safety profiles, individual contra-indications and cost effectiveness.

Reliability of a questionnaire for pharmacological treatment appropriateness in patients with multiple chronic conditions.

BACKGROUND: The original Medication Appropriateness Index was validated for elderly and polymedicated patients, both in hospital and outpatient contexts. However, no studies have applied this questionnaire in patients with multiple chronic conditions. The objective of this study is to assess the reliability of a modified Medication Appropriateness Index questionnaire in a population of patients with multiple chronic conditions. METHODS: We selected patients with multiple chronic conditions who were included in an integrated care project conducted at the Hospital Universitario Virgen del Rocío. To determine inter-observer reliability, each professional (internist or hospital pharmacy specialist) applied the questionnaire under the same conditions and with the same resources. To determine intra-observer reliability, each physician applied the tool at baseline and two months later. We measured inter- and intra-observer reliability using the kappa coefficient. The proportion of overall agreement was also determined. RESULTS: We obtained a weak overall kappa (k=0.38) for inter-observer reliability and moderate (k=0.52) and very good (k=0.84) values for intra-observer reliability of the internist and specialist in hospital pharmacy, respectively. The proportion of overall agreement is very high in all three situations: 96%, 98%, and 99%, respectively. CONCLUSIONS: Despite its limitations, the Medication Appropriateness Index questionnaire modified by our group can be used, as a reliable method, to assess the appropriateness of pharmacotherapy in patients with multiple chronic conditions.

Modelos de atención al paciente pluripatológico y el papel de la farmacia hospitalaria / Health care models for patients with multiple chronic conditions and the role of the hospital pharmacy

Introducción: La atención a los pacientes crónicos constituye actualmente el principal reto que afrontan los sistemas sanitarios. Dentro de estos pacientes, los pacientes pluripatológicos son aquellos que presentan una mayor tendencia a la discapacidad y a la muerte, y consumen mayores recursos. Se caracterizan por la coexistencia de dos o más enfermedades crónicas que duran un año o más y que precisan asistencia médica continuada y/o limitan las actividades diarias. Son los pacientes crónicos que más se pueden beneficiar de una atención farmacéutica, por lo que deberían ser objetivo prioritario de la farmacia hospitalaria. Objetivo: Dar a conocer la importancia de este colectivo de pacientes y las características de los principales modelos de atención y enfoques propuestos, así como resaltar la conveniencia de que el farmacéutico de hospital se integre con prontitud en estos modelos y exponer algunas actividades que debería desempeñar en el seno de los mismos. Resultados: Existen numerosos modelos en el panorama internacional, fundamentalmente el Chronic Care Model y la pirá - mide de riesgos de Kaiser Permanente. En nuestro país hay un desarrollo creciente de iniciativas que han culminado en la reciente Declaración de Sevilla. Para la farmacia hospitalaria la atención a crónicos en un modelo multiprofesional, cooperativo, integral y centrado en el paciente es todo un desafío. Los servicios de farmacia y la SEFH deberán reorientar sus estrategias de atención farmacéutica, la formación y la investigación. En especial, cobran interés las actividades dirigidas a mejorar la adherencia, la adecuación y la continuidad de los tratamientos, con énfasis en la participación activa del paciente (AU)

Introduction: Managing care for patients with chronic conditions currently represents one of the greatest challenges to health care systems. As a subgroup of these patients, those with multiple chronic conditions are at greater risk for death or disability, and they consume more resources. They are characterized by the coexistence of two or more chronic illnesses lasting a year or longer which require ongoing medical attention and/or interfere with their daily activities. For these polypathological patients pharmaceutical care would be of special benefit, thus, their needs should be a priority objective for hospital pharmacy. Objective: To increase awareness of this type of patients and the characteristics of the principal approaches and health care models proposed to improve chronic disease management, as well as to emphasize the urgency for hospital pharmacists to join these models, and to present various activities that pharmacists might carry out as an integral part of these approaches. Results: Numerous models exist internationally, including the Chronic Care Model and the Kaiser Permanente pyramid of risks. In our country a growing number of initiatives has culminated in the recent Seville Declaration. For the hospital pharmacy, caring for the chronically ill patient following a model that is multi-professional, cooperative, integral, and patient centered, is an enormous task. Pharmacy departments and the Spanish Society of Hospital Pharmacy should reorient their strategies for pharmaceutical care, training, and research. Of special interest are those activities designed to improve adherence, adequacy, and continuity in treatments, all the while emphasizing active patient participation (AU)

[Health care models for patients with multiple chronic conditions and the role of the hospital pharmacy/the hospital pharmacist]. / Modelos de atención al paciente pluripatológico y el papel de la farmacia hospitalaria.

INTRODUCTION: Managing care for patients with chronic conditions currently represents one of the greatest challenges to health care systems. As a subgroup of these patients, those with multiple chronic conditions are at greater risk for death or disability, and they consume more resources. They are characterized by the coexistence of two or more chronic illnesses lasting a year or longer which require ongoing medical attention and/or interfere with their daily activities. For these polypathological patients pharmaceutical care would be of special benefit, thus, their needs should be a priority objective for hospital pharmacy. OBJECTIVE: To increase awareness of this type of patients and the characteristics of the principal approaches and health care models proposed to improve chronic disease management, as well as to emphasize the urgency for hospital pharmacists to join these models, and to present various activities that pharmacists might carry out as an integral part of these approaches. RESULTS: Numerous models exist internationally, including the Chronic Care Model and the Kaiser Permanente pyramid of risks. In our country a growing number of initiatives has culminated in the recent Seville Declaration. For the hospital pharmacy, caring for the chronically ill patient following a model that is multi-professional, cooperative, integral, and patient centered, is an enormous task. Pharmacy departments and the Spanish Society of Hospital Pharmacy should reorient their strategies for pharmaceutical care, training, and research. Of special interest are those activities designed to improve adherence, adequacy, and continuity in treatments, all the while emphasizing active patient participation.

Análisis del proceso de selección de nuevos medicamentos en un hospital terciario. Años 2004–07 / Analysis of the selection process for new drugs in a tertiary hospital 2004–2007

Objetivo Describir la estructura de la Comisión de Farmacia y Terapéutica y el proceso de selección de nuevos medicamentos de un hospital terciario. Material y métodos Se revisan todas las actas de la Comisión de Farmacia y Terapéutica y las Guías para la Incorporación de Nuevos Fármacos recibidas en el periodo 2004–2007 en el Hospital Universitario Virgen del Rocío. Se realiza un estudio descriptivo que recoge variables relacionadas con el fármaco (grupo terapéutico, vía de registro, vía de administración y categoría legal), con el solicitante (servicio al que pertenece, categoría profesional y tipo de petición) y con el resultado de la evaluación (decisión final adoptada y tiempo de retraso entre la petición y la decisión).Resultados De los 72 medicamentos solicitados, se aprobaron 45 (62,5%), 6 como equivalentes terapéuticos, 36 (80%) con recomendaciones específicas y 3 (4,2%) sin ninguna restricción. De los fármacos no incluidos, en 12 (81,1%) fue por insuficiente evidencia de su eficacia comparada con el tratamiento actual. El grupo terapéutico solicitado con más frecuencia fue el de los antineoplásicos, destacando Oncología y Hematología entre los peticionarios. Destaca el alto porcentaje de solicitantes que aportaron ensayos clínicos (97,2%) y datos referentes al coste (84,7%).Conclusiones Existe un alto grado cumplimentación de la Guía para la Incorporación de Nuevos Fármacos en nuestro centro que garantiza una decisión final por parte de la Comisión de Farmacia y Terapéutica basada en la evidencia científica (AU)

Material and methods All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision). Results Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%) (AU)

[Analysis of the selection process for new drugs in a tertiary hospital 2004-2007]. / Análisis del proceso de selección de nuevos medicamentos en un hospital terciario. Años 2004-07.

OBJECTIVE: The purpose of this study is to describe the structure of the CFyT, the Pharmacy and Therapeutics Committee, and a tertiary hospital's selection process for new drugs. MATERIAL AND METHODS: All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision). RESULTS: Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%). CONCLUSIONS: There is a high level of compliance with the GINF guide in our centre, which guarantees that the P&TC's final decision is based on scientific evidence.