Assessment of bevacizumab quality and stability in repackaged syringes for clinical use.

OBJECTIVES: Among measures taken to optimise financial resources, the off-label use of bevacizumab (Avastin) in the treatment of age-related macular degeneration (AMD) involves its repackaging from higher volume dosage forms. This use requires studies to analyse the viability of the repackaged preparations to ensure their quality, safety and efficacy. Our aim was to assess the structural stability and particle size of bevacizumab after it was repackaged from the original glass vials and stored in plastic syringes. METHODS: High performance liquid chromatography by size exclusion (HPLC-SE) was used to quantify the bevacizumab and determine its degradation products after stress stability testing, with a particle size counter employed after repackaging and subsequent storage. RESULTS: The syringes stored for 3 days at 4°C maintained the area of the main chromatographic peak above 100±10% of its initial value, and the observed particle size is the same as at baseline (20 nm) but with a double distribution towards larger sizes. CONCLUSIONS: This study shows how the repackaging of Avastin in plastic syringes permits their use for 3 days if stored under normal refrigeration. In this way, hospital pharmacy services can help optimise health resources without compromising the pharmaceutical standards of the drug.

Evaluación económica de la hemodiálisis. Análisis de los componentes del coste basado en datos individuales / Economic evaluation of hemodialysis. Analysis of cost components based on patient-specific data

Antecedentes: El conocimiento del coste de la hemodiálisis (HD) proporciona información del impacto económico de la enfermedad sobre la comunidad. Dicho conocimiento es cru- cial para adecuar y optimizar la asignación de recursos. Nues- tro objetivo ha sido estudiar los costes sanitarios directos por- menorizados de la HD. Además, analizamos el eventual impacto de los factores socioculturales y de comorbilidad so- bre los costes. Material y métodos: Estudio retrospectivo y ob- servacional durante un año de tratamiento con HD basado en datos individuales de pacientes. Se incluyeron todos los pa- cientes del Área Norte de Salud de la Provincia de Tenerife que durante el primer semestre de 2006 llevaran al menos 3 me- ses en HD. Se recogieron variables sociodemográficas y de co- morbilidad mediante una encuesta individual y revisión de ba- ses de datos. Los costes sanitarios fueron organizados en cinco categorías: sesiones de HD; consumo farmacéutico; hospitali- zaciones (evaluado por GRD, grupos relacionados por el diag- nóstico); atención ambulatoria (incluyendo exploraciones complementarias y uso de material sanitario), y empleo de transporte. Resultados: La muestra final fue de 161 enfermos (63 ± 16 años, 63% hombres, 38% diabéticos). Destacó la ele- vada deprivación sociocultural de la población: 75-85% sin graduado escolar y/o trabajos no cualificados. El coste medio del tratamiento global fue de 43.234 ± 13.932 € . La propor- ción de costes fue: sesiones HD 51%, gastos farmacéuticos 27%, hospitalizaciones 17%, transporte 3% y atención ambu- latoria 2%. No se demostró una asociación relevante entre el perfil sociocultural o la comorbilidad y el coste del tratamien- to. Conclusiones: Es el primer estudio de coste de HD por com- ponentes de gasto, basado en datos individuales, e introdu- ciendo el modelo de GDR para los costes de hospitalización. La mayor partida de gastos correspondió a las sesiones de HD y medicación (78%), ambos factores son muy homogéneos en esta población, minimizando el impacto del perfil demográfi- co y de comorbilidad. El ahorro económico debe buscarse fun- damentalmente en la prevención (AU)

Background: Hemodialysis (HD) cost analysis provides information about the economic impact of the disease on the community. Its knowledge is crucial to adequate and optimize health resources. Our aim was to study sanitary and non-sanitary direct costs of HD, based on patients individual data. Furthermore, the effect of sociocultural factors and comorbidity on costs will be evaluated. Material and methods: Retrospective and observational study of prevalence costs produced during one year of HD therapy. All patients from North Health District of Tenerife province (Canary Islands, Spain) included for at least 3 months on HD were considered for the study. Sociodemographic parameters and comorbidity data were collected from a generic individual survey and reviewing database records. Direct sanitary and non-sanitary costs were organized in 6 categories: HD sesions, medicaction costs, hospitalization costs (evaluated by Diagnosis-Related Groups classification system), outpatient care (including consultation and complementary studies); sanitary material and patient transportation. Results: Finally, 161 patients were included (63 ± 16 years, 63% males, 38% diabetics). Of note, the proportions of sociocultural deprivation was high among this population (75-85% did not complete first school and had non- qualified jobs. Mean cost ot global therapy was 43,070 ± 13,932 € . Proportional allocation of costs was as follow: HD sesion 51%, pharmacy 27%, hospitalization 17%, transportation 3% and ambulatory cares 2%. It was not association between sociocultural profile, comorbidity and therapy cost. Conclusions: This is the first study of HD costs, itemized by components of expenses, based in individual data and introducing GRD model for hospitalization cost. The highest expenses corresponded to HD sesions and medication (79%), both very homogeneous to this patient population. The saving in economic term should be, fundamentally, the prevention of CKD (AU)

[Economic evaluation of haemodialysis. Analysis of cost components based on patient-specific data]. / Evaluación económica de la hemodiálisis. Análisis de los componentes del coste basado en datos individuales.

BACKGROUND: Hemodialysis (HD) cost analysis provides information about the economic impact of the disease on the community. Its knowledge is crucial to adequate and optimize health resources. Our aim was to study sanitary and non-sanitary direct costs of HD, based on patients individual data. Furthermore, the effect of sociocultural factors and comorbidity on costs was evaluated. MATERIAL AND METHODS: Retrospective and observational study of prevalence costs produced during one year of HD therapy. All patients from North Health District of Tenerife province (Canary Islands, Spain) included for at least 3 months on HD were considered for the study. Sociodemographic parameters and comorbidity data were collected from a generic individual survey and reviewing database records. Direct sanitary and non-sanitary costs were organized in 6 categories: HD sessions, medication costs, hospitalization costs (evaluated by Diagnosis-Related Groups classification system), outpatient care (including consultation and complementary studies); healthcare material and patient transportation. RESULTS: Finally, 161 patients were included (63 +/- 16 years, 63% males, 38% diabetics). Of note, the proportions of sociocultural deprivation was high among this population (75-85% did not complete first school and had non-qualified jobs). Mean cost of global therapy was 43,070 +/- 13,932 euro. Proportional allocation of costs was as follow: HD sesion 51%, pharmacy 27%, hospitalization 17%, transportation 3% and ambulatory care 2%. There was no association between sociocultural profile, comorbidity and therapy cost. CONCLUSIONS: This is the first study of HD costs, itemized by components of expenses, based in individual data and introducing GRD model for hospitalization cost. The highest expenses corresponded to HD sessions and medication (79%), both very homogeneous to this patient population. The saving in economic terms should be, fundamentally, the prevention of CKD.

Therapeutic effects of hidrosmin on chronic venous insufficiency of the lower limbs.

A double-blind, placebo-controlled trial was carried out to assess the effectiveness of a new synthetic bioflavonoid, hidrosmin, in patients with chronic venous insufficiency of the lower limbs. Fifty-seven patients, showing varicose veins and ankle swelling and suffering from local pain and heaviness of the legs, were allocated at random to receive treatment for 45 days with 1 capsule 3-times daily of either 200 mg hidrosmin (30 patients) or placebo (27 patients). Pain and heavy legs were assessed using rating scales; swelling was assessed by a photographic method. The results showed that hidrosmin produced a significant clinical improvement in all of the parameters evaluated; compared with placebo, there was a marked reduction in the main subjective symptoms accompanied by a 10% reduction in swelling. Apart from 1 patient who complained of epigastric pain, there were no reports of adverse events during the study period.