Dalbavancin as consolidation therapy for infective endocarditis in patients with comorbidity. A real world experience.

OBJECTIVE: Infective endocarditis (IE) is a potentially life-threatening infection, the incidence of which has in creased in recent decades, particularly among elderly patients with comorbidity. The primary objective of this study was to evaluate the effectiveness of dalbavancin in the consolidation therapy of IE in patients with comorbidity six months after the end of treatment (EOT). METHODS: An observational and retrospective study was conducted on patients with a Charlson Comorbidity Index (CCI) ≥ 3 who were diagnosed with IE and received consolidation therapy with dalbavancin. RESULTS: Forty-eight patients were included, 58.3% were male, mean age of 76.2 years (IQR: 66-88), and a mean age adjusted CCI of 6.5 (IQR: 5-7.5). Definite IE was diagnosed in 77% of cases. The most frequently isolated microorganisms were Staphylococcus aureus (45.8%) followed by Enterococcus spp. (31.3%). Complications of IE were observed in 67.7% of cases, and cardiac surgery was performed in 27% of patients. The primary reason for using dalbavancin was outpatient parenteral antibiotic therapy in 85.4% of cases. The effectiveness at EOT was 93.8%. At six months, six IE-related deaths, four unrelated deaths, and two IE relapses were observed. The effectiveness was 77%. Adverse effects related to DBV were reported in 4.2% of cases, of which 2% were considered serious. CONCLUSIONS: Dalbavancin has proven to be an effective alternative as consolidation antibiotherapy for IE in elderly patients with comorbidity. Moreover, a very favorable safety profile with few associated adverse effects has been observed in this population.

Drug Cost Avoidance in Prostate Cancer Clinical Trials.

OBJECTIVES: Economic impact of prostate cancer is increasing in relation to its increased incidence and increased patient survival. Clinical trials are essential to evaluate the efficacy and safety of new treatments but may also result in economic benefits by avoiding the cost of the drug. Our objective is to determine the avoided cost in investigational drugs in clinical trials of prostate cancer conducted in a period of 18 years in a tertiary center. MATERIAL AND METHODS: We carried out an observational of prevalence study with retrospective collected data of clinical trials involving currently marketed drugs and cost avoidance during the study period (1996-2013) was calculated. RESULTS: We include in this review five clinical trials on prostate cancer that met selection criteria of 18 performed. All of them were phase III, multicenter, international and with current marketed drugs. 136 patients were included. Total cost avoidance of 696,002€ and an average cost avoidance by clinical trial of 139,200€ were obtained. Average cost avoidance per patient was 5,118€. CONCLUSION: Cost avoidance in investigational drugs is a tangible benefit of clinical trials, whose realization is a source of economic benefits for the hospital, not only by directly generated by each trial. Clinical trials are an exceptional framework for progress in clinical research and real savings for the health system.

Indicadores de calidad en el proceso de almacenamiento y dispensación de medicamentos en un Servicio de Farmacia Hospitalaria / Quality indicators in the storage and dispensing process in a Hospital Pharmacy

Objetivo. Establecer indicadores para evaluar la calidad de los procesos de almacenamiento y dispensación relacionados con los sistemas semiautomáticos de carrusel vertical (SSADV) y horizontal (SSADH). Material y métodos. Estudio observacional descriptivo entre enero-diciembre de 2012. Definición de indicadores de calidad, se estableció un valor objetivo planificado (OP) y se calculó el valor en el año 2012 (VO). Resultados. Se definieron y calcularon 5 indicadores de calidad en el proceso de almacenamiento y dispensación de medicamentos relativos a: indicador 1, error de llenado de carro de unidosis: OP (< 1,67%), VO (1,03%); indicador 2, precisión del llenado de los carros de unidosis utilizando un SSADV: OP (< 15%); VO (11,5%); indicador 3, fiabilidad del inventario de medicamentos en el proceso de entradas de medicamentos en un SSADH: OP (< 15%); VO (6,53%); indicador 4, fiabilidad del inventario de medicamentos en el proceso de preparación de pedidos de planta de medicamentos en un SSADH: OP (< 10%), VO (1,97%); indicador 5, precisión del proceso de preparación de pedidos de medicamentos de las unidades clínicas utilizando el SSADH: OP (< 10%), VO (10,41%). Conclusiones. El establecimiento de indicadores ha permitido valorar la calidad en términos de seguridad, de precisión y fiabilidad de los sistemas semiautomáticos para el almacenamiento y dispensación de medicamentos (AU)

Objective. To establish indicators for the evaluation of the quality of the storage and dispensing processes related to semiautomatic vertical (SAVCS) and horizontal (SAHCS) carousel systems. Material and Methods. Descriptive observational study conducted between January-December 2012. Definition of quality indicators, a target value is established and an obtained value is calculated for 2012. Results. Five quality indicators in the process of storage and dispensing of drugs were defined and calculated: indicator 1, error filling unidose trolleys: target (< 1.67%), obtained (1.03%); indicator 2, filling accuracy unidose trolleys by using an SAVCS: target (< 15%), obtained (11.5%); indicator 3, reliability of drug inventory in the process of drug entries using an SAHCS: target (< 15%), obtained (6.53%); indicator 4, reliability of drug inventory in the picking process of orders replacement stock of clinical units using an SAHCS: target (< 10%), obtained (1.97%); indicator 5, accuracy of the picking process of drug orders using an SAHCS: target (< 10%), obtained (10.41%). Conclusions. Establishing indicators has allowed the quality in terms of safety, precision and reliability of semiautomatic systems for storage and dispensing drugs to be assessed (AU)

[Quality indicators in the storage and dispensing process in a Hospital Pharmacy]. / Indicadores de calidad en el proceso de almacenamiento y dispensación de medicamentos en un Servicio de Farmacia Hospitalaria.

OBJECTIVE: To establish indicators for the evaluation of the quality of the storage and dispensing processes related to semiautomatic vertical (SAVCS) and horizontal (SAHCS) carousel systems. MATERIAL AND METHODS: Descriptive observational study conducted between January-December 2012. Definition of quality indicators, a target value is established and an obtained value is calculated for 2012. RESULTS: Five quality indicators in the process of storage and dispensing of drugs were defined and calculated: indicator 1, error filling unidose trolleys: target (<1.67%), obtained (1.03%); indicator 2, filling accuracy unidose trolleys by using an SAVCS: target (<15%), obtained (11.5%); indicator 3, reliability of drug inventory in the process of drug entries using an SAHCS: target (<15%), obtained (6.53%); indicator 4, reliability of drug inventory in the picking process of orders replacement stock of clinical units using an SAHCS: target (<10%), obtained (1.97%); indicator 5, accuracy of the picking process of drug orders using an SAHCS: target (<10%), obtained (10.41%). CONCLUSIONS: Establishing indicators has allowed the quality in terms of safety, precision and reliability of semiautomatic systems for storage and dispensing drugs to be assessed.

Seguimiento de la utilización de vigabatrina en relación a la modificación de su ficha técnica / Monitoring vigabatrin use in relation to its modified prescribing information

La ficha técnica de la vigabatrina fue modificada en diciembre de 1999 tras la publicación de casos documentados de defectos de campo visual. Hemos realizado un estudio retrospectivo de los pacientes a tratamiento con vigabatrina en el momento de la modificación, con el objetivo de conocer la adecuación de los mismos a las nuevas recomendaciones. Resultados: 35 pacientes estudiados, de edad media 24 años (3-63), a tratamiento con vigabatrina durante una media de 3,6 años (6 meses - 9 años). A 29 de ellos se les retiró la vigabatrina y 6 pacientes con crisis parciales generalizadas, continuaron con la misma. Se realizaron revisiones oftalmológicas específicas de los campos a 10/35 pacientes, de los cuales 7 presentaron defectos del campo visual y 5 realizaron revisiones periódicas posteriores. De los pacientes que continúan a tratamiento con vigabatrina, el 100 per cent se ajusta a las nuevas indicaciones y condiciones de prescripción, mientras que sólo al 33 per cent se le realizaron pruebas específicas de los campos y el 16 per cent realiza controles periódicos (AU)