Alternatives for the administration of oral antineoplastics in patients with swallowing difficulties.

Oncology patients often experience swallowing difficulties, which can compromise adherence to treatment and consequently reduce its effectiveness. Improper handling of these hazardous drugs can lead to the risk of inhalation of particles or other exposures endangering the health of the persons involved such as nurses and pharmacists. The aim of this review is to analyse and update the recommendations for the manipulation of oral antineoplastic drugs in patients with swallowing difficulties. A literature review of articles, websites, guidelines and other documents published up to about the conditions of handling and administration of oral antineoplastic agents in oncology and oncohaematology was carried out. A table of 110 active principles was compiled. The information was grouped according to the name of the drug, instructions for oral and nasogastric tube administration and suggested recommendations. Among the drugs reviewed, 66.4% were suitable for dissolution. Although there is a lot of information in the literature, the nonstop development of new oncological drugs requires continuous updating. Therefore, we have collected the most recent data to provide a consultation tool for healthcare professionals and patients with swallowing difficulties.

This review can be used by all types of healthcare professionals, especially nurses, who handle oncological medicinal drugs. In addition, the safest handling methods for the worker have been recommended.

Compatibilidad de los fármacos administrados en «Y» en las unidades de cuidados intensivos: revisión sistemática / Compatibility of drugs administered as Y-site infusion in intensive care units: A systematic review

Objetivos: Recopilar la información publicada sobre estabilidad de los fármacos usados en el paciente crítico, evaluar la calidad de los datos publicados y generar una tabla de compatibilidad con información actualizada. Diseño: 1) Se realizó una búsqueda sistemática en las bases de datos Medline, Stabilis, Handbook on Injectable Drugs y Micromedex, para completar y actualizar la información disponible. Se incluyeron los estudios publicados entre 1990 y 2017 redactados en inglés, español y francés; 2) se analizó la calidad de los artículos según los criterios indicados en las guías de práctica para estudios de estabilidad; 3) se construyó una tabla de compatibilidades con los datos hallados para las combinaciones binarias de 44 fármacos de uso frecuente en unidades de cuidados intensivos (UCI). Ámbito: UCI de hospitales españoles e internacionales. Resultados: La revisión sistemática incluyó 29 artículos (27 originales y 2 revisiones). Ningún estudio cumplió todos los criterios de calidad establecidos, aunque el 93% garantizaba una correcta reproducibilidad. La tabla final aporta datos de compatibilidad fisicoquímica de 475 de las 945 combinaciones posibles (50,3%), de las cuales 366 (77,1%) son compatibles y 80 (16,8%) son incompatibles. Conclusiones: Se proporciona una actualización de las compatibilidades entre los fármacos habitualmente empleados en las UCI, con la intención de contribuir a la administración segura de medicamentos en pacientes críticos

Objectives: To gather all published information about the stability of drugs commonly used in Intensive Care Units (ICU); evaluate the methodology of published data; and generate a compatibility table. Design: i) A systematic review was conducted searching the following databases: Medline, Stabilis, Handbook of Injectable Drugs and Micromedex. Articles published from 1990 to 2017 in English, Spanish and French were included. ii) Article quality was analyzed according to the stability studies practice guidelines. iii) A compatibility table was produced with data for 44 binary combinations of drugs frequently used in the ICU. Scope: Spanish and international hospital ICU. Results: The systematic review included 29 studies (27 originals, 2 reviews). None of the included studies followed all the methodological requirements. However, 93% guaranteed correct reproducibility. Accordingly, drug stability knowledge was available for 50.3% of the studied admixtures, in which 77.1% of the binary combinations proved compatible and 16.8% proved incompatible. Conclusions: This review provides new reliable evidence about the physicochemical stability of drugs commonly used in the critical care setting. The study contributes to the safe administration of intravenous drugs in critical patients with a view to avoiding adverse events in this frail population

Compatibility of drugs administered as Y-site infusion in intensive care units: A systematic review. / Compatibilidad de los fármacos administrados en «Y¼ en las unidades de cuidados intensivos: revisión sistemática.

OBJECTIVES: To gather all published information about the stability of drugs commonly used in Intensive Care Units (ICU); evaluate the methodology of published data; and generate a compatibility table. DESIGN: i) A systematic review was conducted searching the following databases: Medline, Stabilis, Handbook of Injectable Drugs and Micromedex. Articles published from 1990 to 2017 in English, Spanish and French were included. ii) Article quality was analyzed according to the stability studies practice guidelines. iii) A compatibility table was produced with data for 44 binary combinations of drugs frequently used in the ICU. SCOPE: Spanish and international hospital ICU. RESULTS: The systematic review included 29 studies (27 originals, 2 reviews). None of the included studies followed all the methodological requirements. However, 93% guaranteed correct reproducibility. Accordingly, drug stability knowledge was available for 50.3% of the studied admixtures, in which 77.1% of the binary combinations proved compatible and 16.8% proved incompatible. CONCLUSIONS: This review provides new reliable evidence about the physicochemical stability of drugs commonly used in the critical care setting. The study contributes to the safe administration of intravenous drugs in critical patients with a view to avoiding adverse events in this frail population.

Fabricación a terceros: sí, pero / Outsourcing: yes, but...

No disponible

Potentially inappropriate prescription in patients with a history of allergy to Beta-lactam antibiotics: a health care challenge

No disponible

[Design of a risk matrix to assess sterile formulations at health care facilities]. / Diseño de una matriz de riesgo para la valoración de los preparados estériles en los centros sanitarios.

OBJECTIVE: To design a matrix allowing classifying sterile formulations prepared at the hospital with different risk levels. MATERIAL AND METHODS: i) Literature search and critical appraisal of the model proposed by the European Resolution CM/Res Ap(2011)1, ii) Identification of the risk associated to the elaboration process by means of the AMFE methodology (Modal Analysis of Failures and Effects), iii) estimation of the severity associated to the risks detected. After initially trying a model of numeric scoring, the classification matrix was changed to an alphabetical classification, grading each criterion from A to D.Each preparation assessed is given a 6-letter combination with three possible risk levels: low, intermediate, and high. This model was easier for risk assignment, and more reproducible. RESULTS: The final model designed analyzes 6 criteria: formulation process, administration route, the drug's safety profile, amount prepared, distribution, and susceptibility for microbiological contamination.The risk level obtained will condition the requirements of the formulation area, validity time, and storing conditions. CONCLUSIONS: The matrix model proposed may help health care institutions to better assess the risk of sterile formulations prepared,and provides information about the acceptable validity time according to the storing conditions and the manufacturing area. Its use will increase the safety level of this procedure as well as help in resources planning and distribution.

Objetivo: Diseñar una matriz que permita la clasificación de los preparadosestériles que se elaboran en el hospital en diferentes nivelesde riesgo.Material y métodos: i) Revisión bibliográfica y lectura crítica delmodelo propuesto por la resolución europea CM/ResAp(2011)1, ii)Identificación de los riesgos asociados al proceso de elaboración,mediante metodología AMFE (Análisis Modal de Fallos y Efectos),iii) estimación de la gravedad asociada a los riesgos detectados.Tras probar inicialmente un modelo de puntuación numérica, semodificó la matriz a una clasificación alfabética, graduando cadacriterio de la A a la D. Cada preparación evaluada obtiene unacombinación de 6 letras, que lleva a tres posibles niveles de riesgo:bajo, medio y alto. Este modelo presentó menor dificultad a la horade asignar riesgos, así como mayor reproducibilidad.Resultados: El modelo final diseñado analiza 6 criterios: proceso depreparación, vía de administración, perfil de seguridad del medicamento,cantidad preparada, distribución y susceptibilidad de contaminaciónmicrobiológica. El nivel de riesgo obtenido condicionarálos requerimientos de la zona de elaboración, plazo de validezy las condiciones de conservación.Conclusiones: El modelo de matriz propuesta puede ayudar a lasinstituciones sanitarias a discernir el riesgo de las preparacionesestériles que se realizan, aportando información sobre el plazo devalidez aceptable en función de las condiciones de conservación yel lugar de fabricación. Su aplicación conllevará un incremento enla seguridad de este proceso, a la vez que puede ayudar a la planificacióny distribución de recursos.

Diseño de una matriz de riesgo para la valoración de los preparados estériles en los centros sanitarios / Design of a risk matrix to assess sterile formulations at health care facilities

Objetivo: Diseñar una matriz que permita la clasificación de los preparados estériles que se elaboran en el hospital en diferentes niveles de riesgo. Material y métodos: i) Revisión bibliográfica y lectura crítica del modelo propuesto por la resolución europea CM/ResAp(2011)1, ii)Identificación de los riesgos asociados al proceso de elaboración, mediante metodología AMFE (Análisis Modal de Fallos y Efectos),iii) estimación de la gravedad asociada a los riesgos detectados. Tras probar inicialmente un modelo de puntuación numérica, se modificó la matriz a una clasificación alfabética, graduando cada criterio de la A a la D. Cada preparación evaluada obtiene una combinación de 6 letras, que lleva a tres posibles niveles de riesgo: bajo, medio y alto. Este modelo presentó menor dificultad a la horade asignar riesgos, así como mayor reproducibilidad. Resultados: El modelo final diseñado analiza 6 criterios: proceso de preparación, vía de administración, perfil de seguridad del medicamento, cantidad preparada, distribución y susceptibilidad de contaminación microbiológica. El nivel de riesgo obtenido condicionará los requerimientos de la zona de elaboración, plazo de validez y las condiciones de conservación. Conclusiones: El modelo de matriz propuesta puede ayudar a las instituciones sanitarias a discernir el riesgo de las preparaciones estériles que se realizan, aportando información sobre el plazo de validez aceptable en función de las condiciones de conservación yel lugar de fabricación. Su aplicación conllevará un incremento enla seguridad de este proceso, a la vez que puede ayudar a la planificación y distribución de recursos (AU)

Objective: To design a matrix allowing classifying sterile formulations prepared at the hospital with different risk levels. Material and methods: i) Literature search and critical appraisal of the model proposed by the European Resolution CM/ResAp(2011)1, ii) Identification of the risk associated to the elaboration process by means of the AMFE methodology (Modal Analysis of Failures and Effects), iii) estimation of the severity associated to the risks detected. After initially trying a model ofnumeric scoring, the classification matrix was changed to analphabetical classification, grading each criterion from A to D.Each preparation assessed is given a 6-letter combination with three possible risk levels: low, intermediate, and high. This model was easier for risk assignment, and more reproducible. Results: The final model designed analyzes 6 criteria: formulation process, administration route, the drug’s safety profile, amount prepared, distribution, and susceptibility for microbiological contamination. The risk level obtained will condition the requirements of the formulation area, validity time, and storing conditions. Conclusions: The matrix model proposed may help health care institutions to better assess the risk of sterile formulations prepared, and provides information about the acceptable validity time according to the storing conditions and the manufacturing area. Its use will increase the safety level of this procedure as well as help in resources planning and distribution (AU)

Ensayo clínico aleatorizado de un programa de atención farmacéutica al alta frente a seguimiento habitual en pacientes con insuficiencia cardiaca / Randomized clinical trial of a postdischarge pharmaceutical care program vs. regular follow-up in patients with heart failure

Objetivo: Valorar la eficacia de una intervención educativa multifactorial realizada por un farmacéutico en pacientes con insuficiencia cardiaca (IC). Método: Ensayo clínico aleatorizado, prospectivo, abierto, en pacientes ingresados por IC. Los pacientes asignados al grupo intervención recibieron información sobre la enfermedad, el tratamiento farmacológico, educación dietética y seguimiento telefónico activo. Se realizaron visitas a los 2, 6 y 12 meses. Se evaluaron los reingresos hospitalarios, días de hospitalización, cumplimiento terapéutico, satisfacción con la atención recibida y calidad de vida (EuroQol); se realizó un estudio económico para valorar el posible impacto del programa. La intervención la efectuó el servicio de farmacia en coordinación con la unidad de cardiología. Resultados: Se han incluido 134 pacientes, de edad media 75 años, nivel de estudios bajo. Los pacientes del grupo intervención presentaron un mayor nivel de adherencia al tratamiento que los pacientes del grupo control. A los 12 meses de seguimiento, los pacientes del grupo intervención reingresaron un 32,9% menos que los del grupo control. El promedio de días de hospitalización por paciente en el grupo control fue de 9,6 (DE = 18,5) frente a 5,9 (DE = 14,1) del grupo intervención. No se registraron diferencias en la calidad de vida, pero el grupo intervención presentó mayor puntuación en la escala de satisfacción a los dos meses [9,0 (DE = 1,3) vs. 8,2 (DE = 1,8) p = 0,026]. Al ajustar un modelo de supervivencia de Cox con la fracción de eyección, los pacientes del grupo intervención presentaron un menor riesgo de reingreso (Hazard ratio 0,56; IC95%: 0,32-0,97). El análisis económico evidenció un ahorro en gastos hospitalarios de 578 € por paciente favorable al grupo intervención. Conclusiones: La atención farmacéutica al alta hospitalaria permite reducir el número de reingresos en pacientes con insuficiencia cardiaca, los días totales de hospitalización y mejora la adherencia al tratamiento sin aumentar los costes de la atención

Objective: To assess the efficacy of a multifactorial educational intervention carried out by a pharmacist in patients with heart failure (HF). Method: A randomized, prospective, open clinical trial in patients admitted for HF. The patients assigned to the intervention group received information about the disease, drug therapy, diet education, and active telephone follow-up. Visits were completed at 2, 6, and 12 months. Hospital re-admissions, days of hospital stay, treatment compliance, satisfaction with the care received, and quality of life (EuroQol) were evaluated; a financial study was conducted in order to assess the possible impact of the program. The intervention was performed by the pharmacy department in coordination with the cardiology unit. Results: 134 patients were included, with a mean age of 75 years and a low educational level. The patients of the intervention group had a higher level of treatment compliance than the patients in the control group. At 12 months of follow-up, 32.9% fewer patients in the intervention group were admitted again vs. the control group. The mean days of hospital stay per patient in the control group were 9.6 (SD = 18.5) vs. 5.9 (SD = 14.1) in the intervention group. No differences were recorded in quality of life, but the intervention group had a higher score in the satisfaction scale at two months [9.0 (SD = 1.3) versus 8.2 (SD = 1.8) p = 0.026]. Upon adjusting a Cox survival model with the ejection fraction, the patients in the intervention group had a lower risk of re-admission (Hazard ratio 0.56; 95% CI: 0.32-0.97). The financial analysis evidenced savings in hospital costs of € 578 per patient that were favorable to the intervention group. Conclusions: Postdischarge pharmaceutical care allows for reducing the number of new admissions in patients with heart failure, the total days of hospital stay, and improves treatment compliance without increasing the costs of care

Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure.

OBJECTIVE: To assess the efficacy of a multifactorial educational intervention carried out by a pharmacist in patients with heart failure (HF). METHOD: A randomized, prospective, open clinical trial in patients admitted for HF. The patients assigned to the intervention group received information about the disease, drug therapy, diet education, and active telephone follow-up. Visits were completed at 2, 6, and 12 months. Hospital re-admissions, days of hospital stay, treatment compliance, satisfaction with the care received, and quality of life (EuroQol) were evaluated; a financial study was conducted in order to assess the possible impact of the program. The intervention was performed by the pharmacy department in coordination with the cardiology unit. RESULTS: 134 patients were included, with a mean age of 75 years and a low educational level. The patients of the intervention group had a higher level of treatment compliance than the patients in the control group. At 12 months of follow-up, 32.9% fewer patients in the intervention group were admitted again vs. the control group. The mean days of hospital stay per patient in the control group were 9.6 (SD=18.5) vs. 5.9 (SD=14.1) in the intervention group. No differences were recorded in quality of life, but the intervention group had a higher score in the satisfaction scale at two months [9.0 (SD=1.3) versus 8.2 (SD=1.8) p=0.026]. Upon adjusting a Cox survival model with the ejection fraction, the patients in the intervention group had a lower risk of re-admission (Hazard ratio 0.56; 95% CI: 0.32-0.97). The financial analysis evidenced savings in hospital costs of euro 578 per patient that were favorable to the intervention group. CONCLUSIONS: Postdischarge pharmaceutical care allows for reducing the number of new admissions in patients with heart failure, the total days of hospital stay, and improves treatment compliance without increasing the costs of care.