Stability of mixtures of ondansetron and haloperidol stored in infusors at different temperatures.

BACKGROUND AND OBJECTIVE: Mixing different drugs for use in continuous infusion systems is a common practice in palliative care, but analytical study of compatibility and stability is not always available. The objective of this work is to study the stability of solutions of ondansetron and haloperidol at different concentrations and temperatures all prepared in 0.9% NaCl and stored in infusors, with all cases protected from light. MATERIALS AND METHODS: The high performance liquid chromatography-Ultraviolet (HPLC-UV) method was employed for the determination of the drugs. The concentrations of the admixtures were 0.15-0.25 mg/mL and 0.3-0.4 mg/mL of haloperidol and ondansetron, respectively, with a storage temperature of 25°C and 37°C. RESULTS: All solutions were initially clear and colourless, but visible particles appear, in all cases, into the infusers after 2 days since their preparation. CONCLUSION: From the results obtained we can conclude that the mixtures prepared in the conditions previously described are stable less than 48 hours.

Nintedanib in combination with docetaxel for second-line treatment of advanced non-small-cell lung cancer; GENESIS-SEFH drug evaluation report.

Nintedanib is a triple angiokinase inhibitor that has been approved by the European Agency Medicines (EMA) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy. In LUME-Lung 1 clinical trial, the combination of nintedanib plus docetaxel vs. placebo plus docetaxel improved progression free survival (PFS) in NSCLC patients, and improved overall survival in the population of adenocarcinoma patients, particularly in those with progression within 9 months after first line treatment initiation, median 10.9 months ( [95% CI 8.5-12.6] vs. 7.9 months [6.7-9.1]; HR 0.75 [95% CI 0.60-0.92], p=0.0073). The toxicity profile of the combination included a higher incidence of neutropenia, gastro-intestinal (GI) disorders, and liver enzyme elevations; however, this did not cause a detrimental effect on patient quality of life. According to data from the clinical trial mentioned, the addition of nintedanib to docetaxel would lead to an estimated incremental cost-effectiveness ratio (ICER) per year of life with PFS in the overall population of 134,274.47 € (notified price). In the adenocarcinoma population per each life of year gained (LYG), the ICER of adding nintedanib to docetaxel would be 40,886.14 €; while by implementing a sensitivity analysis with a 25% discount in the drug price, the cost per LYG would be 32,364.05 €, and would place it close to the threshold of cost-effectiveness usually considered acceptable in our setting. In view of efficacy and safety results the proposed positioning is to recommend its inclusion in the Hospital Formulary only for adult patients with metastatic or locally recurrent NSCLC with adenocarcinoma histology after first line chemotherapy, with progression < 9 months from the initiation of first line treatment, taking into account the inclusion and exclusion criteria in the pivotal clinical trial.

Nintedanib es un inhibidor de la angiogenesis tumoral que esta autorizado por la EMA en combinacion con docetaxel para el tratamiento de pacientes adultos con cancer de pulmon no microcitico (CPNM) localmente avanzado, metastasico o localmente recurrente con histologia tumoral de adenocarcinoma despues de la quimioterapia de primera linea. De acuerdo con los resultados del ensayo LUME-Lung 1, la combinacion de nintedanib mas docetaxel frente a monoterapia con docetaxel muestra una mejora en la supervivencia libre de progresion (SLP) en los pacientes con CPNM y mejora la supervivencia global en el grupo de pacientes con histologia de adenocarcinoma, sobre todo en aquellos cuya progresion tras el inicio a la primera linea fue antes de 9 meses. El perfil de toxicidad de la combinacion muestra un aumento en la incidencia de neutropenia, trastornos digestivos y aumento de transaminasas; sin embargo, esto no produjo mayor deterioro en la calidad de vida de los pacientes. Segun los datos del citado ensayo, con la adicion de nintedanib a docetaxel el coste estimado de cada ano de vida con SLP en la poblacion global con el precio notificado seria de 134.274,47 €. En el grupo de adenocarcinoma, por cada ano de vida ganado (AVG) con la adicion de nintedanib al docetaxel el coste eficacia incremental (CEI) seria de 40.886,14 €, mientras que aplicando un analisis de sensibilidad que supusiera un descuento de un 25% el coste por AVG seria de 32.364,05 €, situandose cerca del umbral de coste-efectividad generalmente considerado en nuestro medio como aceptable. A la vista de los resultados de eficacia y seguridad, el posicionamiento propuesto es recomendar su inclusion en la Guia Farmacoterapeutica solo en pacientes adultos con CPNM metastasico o localmente recurrente con histologia tumoral de adenocarcinoma despues de la quimioterapia de primera linea y en los que la progresion sea < 9 meses desde el inicio de primera linea teniendo en cuenta los criterios de inclusion y exclusion del ensayo pivotal.

Nintedanib in combination with docetaxel for second-line treatment of advanced non-small-cell lung cancer; GENESIS-SEFH drug evaluation report / Nintedanib en combinación con docetaxel como segunda línea de tratamiento del cáncer de pulmón no microcítico localmente avanzado; informe de evaluación GENESIS-SEFH

Nintedanib is a triple angiokinase inhibitor that has been approved by the European Agency Medicines (EMA) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy. In LUME-Lung 1 clinical trial, the combination of nintedanib plus docetaxel vs. placebo plus docetaxel improved progression free survival (PFS) in NSCLC patients, and improved overall survival in the population of adenocarcinoma patients, particularly in those with progression within 9 months after first line treatment initiation, median 10.9 months ( [95% CI 8.5-12.6] vs. 7.9 months [6.7-9.1]; HR 0.75 [95% CI 0.60-0.92], p=0.0073). The toxicity profile of the combination included a higher incidence of neutropenia, gastro-intestinal (GI) disorders, and liver enzyme elevations; however, this did not cause a detrimental effect on patient quality of life. According to data from the clinical trial mentioned, the addition of nintedanib to docetaxel would lead to an estimated incremental cost-effectiveness ratio (ICER) per year of life with PFS in the overall population of 134,274.47 € (notified price). In the adenocarcinoma population per each life of year gained (LYG), the ICER of adding nintedanib to docetaxel would be 40,886.14 €; while by implementing a sensitivity analysis with a 25% discount in the drug price, the cost per LYG would be 32,364.05 €, and would place it close to the threshold of cost-effectiveness usually considered acceptable in our setting. In view of efficacy and safety results the proposed positioning is to recommend its inclusion in the Hospital Formulary only for adult patients with metastatic or locally recurrent NSCLC with adenocarcinoma histology after first line chemotherapy, with progression < 9 months from the initiation of first line treatment, taking into account the inclusion and exclusion criteria in the pivotal clinical trial

Nintedanib es un inhibidor de la angiogénesis tumoral que está autorizado por la EMA en combinación con docetaxel para el tratamiento de pacientes adultos con cáncer de pulmón no microcítico (CPNM) localmente avanzado, metastásico o localmente recurrente con histología tumoral de adenocarcinoma después de la quimioterapia de primera línea. De acuerdo con los resultados del ensayo LUME-Lung 1, la combinación de nintedanib más docetaxel frente a monoterapia con docetaxel muestra una mejora en la supervivencia libre de progresión (SLP) en los pacientes con CPNM y mejora la supervivencia global en el grupo de pacientes con histología de adenocarcinoma, sobre todo en aquellos cuya progresión tras el inicio a la primera línea fue antes de 9 meses. El perfil de toxicidad de la combinación muestra un aumento en la incidencia de neutropenia, trastornos digestivos y aumento de transaminasas; sin embargo, esto no produjo mayor deterioro en la calidad de vida de los pacientes. Según los datos del citado ensayo, con la adición de nintedanib a docetaxel el coste estimado de cada año de vida con SLP en la población global con el precio notificado sería de 134.274,47 €. En el grupo de adenocarcinoma, por cada año de vida ganado (AVG) con la adición de nintedanib al docetaxel el coste eficacia incremental (CEI) sería de 40.886,14 €, mientras que aplicando un análisis de sensibilidad que supusiera un descuento de un 25% el coste por AVG sería de 32.364,05 €, situándose cerca del umbral de coste-efectividad generalmente considerado en nuestro medio como aceptable A la vista de los resultados de eficacia y seguridad, el posicionamiento propuesto es recomendar su inclusión en la Guía Farmacoterapéutica solo en pacientes adultos con CPNM metastásico o localmente recurrente con histología tumoral de adenocarcinoma después de la quimioterapia de primera línea y en los que la progresión sea < 9 meses desde el inicio de primera línea teniendo en cuenta los criterios de inclusión y exclusión del ensayo pivotal

Use of monoclonal antibodies for metastatic colorectal cancer in the Andalusian public health system.

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.

Prevalence of drug interactions in hospital healthcare.

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.

Errores vacunales y situacionesque pueden conducir a erroresen Atención Primaria de salud / Vaccination errors and situations that may lead to mistakes in Primary Care

Objetivo: identificar errores en la administración de vacunas así como situacionesrelacionadas con la similitud de los envases que pudieran dar lugar a errores, enun distrito del Servicio Andaluz de Salud en el año 2007. Los resultados del estudiose utilizaron en una estrategia de difusión, tanto interna como externa.Material y método: estudio descriptivo en el Distrito Sanitario Aljarafe (Sevilla) delServicio Andaluz de Salud (SAS). Se recopiló la información sobre notificacionesde errores en la vacunación durante el año 2007. Se analizaron las similitudesen la denominación y etiquetado entre las vacunas disponibles en los centros.Resultados: se detectaron ocho errores reales por la administración de la vacunaantineumocócica 23-valente en lugar de la vacuna antigripal. Estos errores se debierona la gran similitud en el etiquetado. Se identificaron otros 15 situacionesque pueden conducir a errores relacionadas con el diseño y la denominación. Ladifusión interna se realizó mediante el envío de documentación a los responsablesde la gestión de vacunas en el Área y al Servicio Andaluz de Salud y mediantesesiones informativas para el equipo de Enfermería en los centros. Los errores vacunalesfueron notificados al Instituto para el Uso Seguro de los Medicamentos,que lo comunicó a la Agencia Española de Medicamentos y Productos Sanitariosy a los laboratorios fabricantes de las vacunas implicadas.Conclusiones: las vacunas constituyen un grupo de medicamentos con una alta probabilidadde conducir a errores de administración, relacionados en gran medidacon la similitud en la denominación y el etiquetado. Mientras no se adopten medidaspara diferenciarlas claramente, se requiere el esfuerzo de los profesionalesen la identificación correcta de los cartonajes para evitar errores en la administración (AU)

Objective: to identify errors in the administration of vaccines as well as errors thatcould be a result of similar packaging, in a district of the Andalusian Health Servicein 2007. The results of this study were used in both an internal and externaldissemination strategy.Material and method: descriptive study in the Health District of Aljarafe (Seville)of the Andalusian Health Service (AHS). Information regarding vaccination errorsreported in 2007 was gathered. Similarities in the names and labelling of the differentvaccines available in the centres were analyzed.Results: eight real errors were detected after the administration of the 23-valentantipneumococcic vaccine instead of the flu vaccine. These errors were due to thehighly similar labelling of both types of vaccine. 15 other situations which couldlead to errors related with design and name were identified. Internal disseminationwas carried out via the distribution of documentation to those in charge of vaccinemanagement in the Area and to the Andalusian Health Service and by meansof informative sessions for the Nursing team in these centres. Vaccination errorswere reported to the Institute for the Safe Use of Drugs, which in turn informedthe Spanish Drug and Healthcare Products Agency and laboratories which manufacturedthe vaccines involved.Conclusions: vaccines are a group of drugs presenting a high probability of leadingto administration errors due to their similarities in name and labelling. Untilmeasures are adopted to clearly differentiate them, professionals are required tobe careful in the correct identification of drug packages to avoid administrationerrors (AU)