Standardization and Chemical Characterization of Intravenous Therapy in Adult Patients: A Step Further in Medication Safety.

BACKGROUND: Intravenous drug administration is associated with potential complications, such as phlebitis. The physiochemical characteristics of the infusate play a very important role in some of these problems. AIM: The aim of this study was to standardize the dilutions of intravenous drugs most commonly used in hospitalized adult patients and to characterize their pH, osmolarity and cytotoxic nature to better guide the selection of the most appropriate vascular access. METHODS: The project was conducted in three phases: (i) standardization of intravenous therapy, which was conducted using a modified double-round Delphi method; (ii) characterization of the dilutions agreed on in the previous phase by means of determining the osmolarity and pH of each of the agreed concentrations, and recording the vesicant nature based on the information in literature; and (iii) algorithm proposal for selecting the most appropriate vascular access, taking into account the information gathered in the previous phases. RESULTS: In total, 112 drugs were standardized and 307 different admixtures were assessed for pH, osmolarity and vesicant nature. Of these, 123 admixtures (40%), had osmolarity values >600 mOsm/L, pH < 4 or > 9, or were classified as vesicants. In these cases, selection of the most suitable route of infusion and vascular access device is crucial to minimize the risk of phlebitis-type complications. CONCLUSIONS: Increasing safety of intravenous therapy should be a priority in the healthcare settings. Knowing the characteristics of drugs to assess the risk involved in their administration related to their physicochemical nature may be useful to guide decision making regarding the most appropriate vascular access and devices.

Agentes hemostáticos tópicos de uso quirúrgico / Topical hemostatic agents for surgical use

Introducción: La morbilidad, mortalidad y costes tras la cirugía se hallan influenciados en gran medida por la pérdida hemática o hemorragia y las consecuencias derivadas de la misma. Para controlar la hemorragia, es frecuente el uso de agentes hemostáticos tópicos en combinación o en adyuvancia a otras técnicas hemostáticas, cuando éstas resultan ineficaces o impracticables. Material y métodos: Se realizó una revisión sistemática en Cochrane y MEDLINE desde el año 2000 a 2017 para identificar las publicaciones relacionadas con el uso de hemostáticos pasivos, activos y sellantes en comparación con otros agentes hemostáticos en todos los tipos de intervenciones quirúrgicas. Resultados: Se seleccionaron 20 ensayos clínicos. La variable principal de eficacia en el 95% fue el tiempo hasta la hemostasia y en el 5% la disminución del sangrado. Las intervenciones quirúrgicas más frecuentes fueron; cirugía hepática (30%), vascular (20%), cardíaca (10%), espinal (10%), general (5%), plástica (5%), y otros tipos de cirugía (20%).Los estudios se dividieron en 7 grupos, en función del tipo de agente hemostático a estudio y el comparador: a) hemostáticos mixtos versus pasivos (10%), b) sellantes de fibrina versus hemostáticos activos (5%), c) sellantes de fibrina versus hemostáticos pasivos (50%), d) hemostáticos mixtos entre sí (15%), e) sellantes de fibrina entre sí (5%), f) hemostáticos pasivos entre sí (5%), g) hemostáticos activos entre sí (10%).Conclusiones: Los hemostáticos activos, mixtos y sellantes de fibrina demuestran superioridad frente a los pasivos en términos de eficacia clínica, con un coste superior y un perfil de efectos adversos similar. (AU)

Introduction: Morbidity, mortality, and costs after surgery are greatly influenced by blood loss or bleeding and the consequences of it.To control bleeding, the use of topical hemostatic agents in combination or adjuvant to other hemostatic techniques is frequent, when these are ineffective or impractical.Method: A systematic review was conducted in Cochrane and PubMed from 2000 to 2017 to identify publications related to the use of passive, active and sealant hemostatics compared to other hemostatic agents in all types of surgical interventions.Results: Twenty clinical trials were selected. The main variable of efficacy in 95% was the time to hemostasis and in 5% the decrease in bleeding.The most frequent surgical interventions were; liver surgery (30%), vascular (20%), cardiac (10%), spinal (10%), general (5%), plastic (5%), and other types of surgery (20%).The studies were divided into 7 groups, depending on the type of hemostatic agent under study and the comparator: a) mixed hemostatic versus passive (10%), b) fibrin sealants versus active hemostatic agents (5%), c) fibrin sealants versus passive hemostatic (50%), d) mixed hemostatic with each other (15%), e) fibrin sealants with each other (5%), f) passive hemostatic with each other (5%), g) active hemostatic with each other (10%).Conclusions: Active and mixed hemostatics and fibrin sealants showed superiority over the passive hemostatics in terms of clinical efficacy, with a higher cost and a similar profile of side effects. (AU)

Mascarillas: producto imprescindible en la pandemia COVID-19 / Masks: essential product in the pandemic COVID-19

Las mascarillas son un elemento básico de protección y limitación de la propagación de la infección por coronavirus. En concreto y en la situación de pandemia sanitaria mundial ante la que nos encontramos frente al COVID-19. Podemos diferenciar varios tipos de mascarillas (quirúrgicas, autofiltrantes, higiénicas, etc.), teniendo cada una de ellas una consideración diferente en cuanto a tipo de producto, requisitos normativos y protección que nos ofrecen. La situación de pandemia actual en la que nos encontramos, hace imprescindible el uso de las mismas para limitar la propagación de agentes infecciosos

Masks are a basic element of protection and limitation of the spread of coronavirus infection. We can distinguish several types of masks (surgical, auto filtering, hygienical, etc.), which have different considerations related to the type of product, regulatory requirements, and grade of protection. The current pandemic situation makes essential the use of masks to limit the spread of infectious agents

Revisión de la evidencia sobre el manejo de medicamentos y productos peligrosos en los servicios de Urología. Documento de consenso entre la Asociación Española de Urología y la Sociedad Española de Farmacia Hospitalaria / Review of the evidence on handling drugs and hazardous products in Urology Departments. Consensus document between the Spanish Urological Association and the Spanish Society of Hospital Pharmacy

Introducción: La administración intravesical de medicamentos peligrosos es una práctica habitual en el ámbito de la urología, con posible exposición del personal sanitario a dichos medicamentos. Se considera necesario disponer de un documento de consenso entre las sociedades científicas implicadas -Asociación Española de Urología y Sociedad Española de Farmacia Hospitalaria- que recoja la mejor evidencia disponible para el manejo, de la forma más segura posible, de medicamentos peligrosos en el ámbito de los servicios de Urología. Métodos: Se ha realizado una revisión de la legislación y de las recomendaciones sobre el manejo de medicamentos peligrosos tanto a nivel estatal como internacional. Resultados: Se dispone de legislación nacional y de normativas para la protección de los trabajadores que manipulen medicamentos y productos peligrosos, así como recomendaciones de manipulación para la protección tanto del producto, como de los trabajadores. Discusión: Siguiendo las líneas estratégicas del Parlamento Europeo para el período 2014-2020 en el capítulo de seguridad y salud laboral, la Asociación Española de Urología y la Sociedad Española de Farmacia Hospitalaria proponen una serie de actuaciones que hagan disminuir los riesgos de exposición a los profesionales y cuidadores implicados en su manejo. Conclusiones: Tras esta revisión se establecen 19 recomendaciones para el manejo de medicamentos peligrosos que pueden resumirse en la necesidad de formación de todas las personas implicadas (desde equipos directivos hasta los pacientes y cuidadores), adopción de sistemas que no permitan fugas contaminantes, programas de vigilancia de las exposiciones y optimización de los recursos disponibles

Background: The intravesical administration of hazardous drug products is a standard practice in the urology setting, which potentially exposing medical personnel to these drug products. It was deemed necessary to have a consensus document among the scientific societies involved (the Spanish Urological Association and the Spanish Society of Hospital Pharmacy) that collects the best available evidence on the safest handling possible of dangerous drug products in the setting of urology departments. Methods: We reviewed the legislation and recommendations on the handling of dangerous drug products, both at the national and international level. Results: There is national legislation and regulations for protecting workers who handle dangerous drugs and products, as well as recommendations for handling to protect both the product and workers. Discussion: Following the strategic lines of the European Parliament for 2014-2020 in the chapter on occupational safety and health, the Spanish Urological Association and the Spanish Society of Hospital Pharmacy proposed a series of actions that decrease the risks of exposure for practitioners and caregivers involved in the handling of these products. Conclusions: After this review, 19 recommendations were established for handling dangerous drug products, which can be summarised as the need to train all individuals involved (from management teams to patients and caregivers), adopt systems that prevent contaminating leaks, implement exposure surveillance programmes and optimise available resources

Review of the evidence on handling drugs and hazardous products in Urology Departments. Consensus document between the Spanish Urological Association and the Spanish Society of Hospital Pharmacy. / Revisión de la evidencia sobre el manejo de medicamentos y productos peligrosos en los servicios de Urología. Documento de consenso entre la Asociación Española de Urología y la Sociedad Española de Farmacia Hospitalaria.

BACKGROUND: The intravesical administration of hazardous drug products is a standard practice in the urology setting, which potentially exposing medical personnel to these drug products. It was deemed necessary to have a consensus document among the scientific societies involved (the Spanish Urological Association and the Spanish Society of Hospital Pharmacy) that collects the best available evidence on the safest handling possible of dangerous drug products in the setting of urology departments. METHODS: We reviewed the legislation and recommendations on the handling of dangerous drug products, both at the national and international level. RESULTS: There is national legislation and regulations for protecting workers who handle dangerous drugs and products, as well as recommendations for handling to protect both the product and workers. DISCUSSION: Following the strategic lines of the European Parliament for 2014-2020 in the chapter on occupational safety and health, the Spanish Urological Association and the Spanish Society of Hospital Pharmacy proposed a series of actions that decrease the risks of exposure for practitioners and caregivers involved in the handling of these products. CONCLUSIONS: After this review, 19 recommendations were established for handling dangerous drug products, which can be summarised as the need to train all individuals involved (from management teams to patients and caregivers), adopt systems that prevent contaminating leaks, implement exposure surveillance programmes and optimise available resources.

[Parenteral administration medicines: recommendations of preparation, administration and stability]. / Medicamentos de administración parenteral: recomendaciones de preparación, administración y estabilidad.

OBJECTIVE: To develop recommendations for the preparation of parenteral drugs (MAP), to assess the transferability of their preparation, from nursing units in the hospital ward to the pharmacy service (SF). METHOD: A table of stabilities of parenteral drugs included in the pharmacotherapeutic guideline was developed using the american and spanish guidelines. Information about MAP was collected (method of preparation, support, maintenance, validity, administration specifications and packaging) by consulting product technical sheets, pharmaceutical industries, literature review and databases. RESULTS: After reviewing 209 drugs, a list of recommendations was developed. According to the data, MAP will be prepared as follows: 89 drugs will be prepared from SF, 62 drugs at nursing units because of its immediate administration requirement and 58 are already packed for its administration by the industry. Of these 62 drugs prepared a nursing units, 14 of them will be prepared in the following doses by the SF. Therefore, 48 drugs will be prepared at nursing units from the 209 parenteral drugs reviewed. CONCLUSIONS: A standardized method of preparation, storage, administration and validity of MAP was established by the SF. The preparation of MAP in the SF extends its shelf life, by considering physicochemical stability, level of risk and product vulnerability to microbiological contamination. The information provided will contribute to a reduction of errors associated with the preparation and administration of MAP.

Objetivo: Elaborar unas recomendaciones de preparacion de medicamentos de administracion parenteral (MAP) para valorar la posibilidad de transferir su preparacion, desde las unidades de enfermeria en planta de hospitalizacion al servicio de farmacia (SF). Método: Se procede a elaborar una tabla de estabilidades de los medicamentos incluidos en la guia farmacoterapeutica del Hospital, aplicando la Guia USP (Pharmaceutical compounding Sterile Preparations) y la Guia de de buenas practicas de preparacion de medicamentos en los servicios de farmacia hospitalaria. Se recopilo informacion sobre las MAP: metodo de preparacion, compatibilidad, conservacion, periodo de validez, modo de administracion y tipo de envase. Los datos se obtuvieron mediante consulta de las fichas tecnicas, laboratorios, revision bibliografica y otras bases de datos. Resultados: Tras revisar 209 farmacos se elaboro un listado de recomendaciones. Segun los datos obtenidos, las MAP se prepararan de la siguiente forma: 89 seran preparadas desde el SF, 62 en unidad de enfermeria en planta de hospitalizacion pues son medicamentos que requieren administracion inmediata y 58 ya van acondicionados para su administracion por la industria. De los 62 farmacos que se prepararan por enfermeria, en 14 de ellos las dosis siguientes se prepararan desde el SF. Por lo tanto de los 209 farmacos solo 48 se prepararan exclusivamente en la unidad de enfermeria. Conclusiones: Desde el SF se ha establecido un metodo normalizado de preparacion, conservacion, administracion y periodo de validez de MAP. La preparacion de MAP en SF ampliaria su tiempo de conservacion, al tener en cuenta la estabilidad fisicoquimica, el nivel de riesgo y la vulnerabilidad del preparado a la contaminacion microbiologica. La informacion aportada contribuira a una disminucion de errores asociados al proceso de preparacion y administracion de MAP.

Medicamentos de Administración Parenteral: Recomendaciones de preparación, administración y estabilidad / Parenteral administration medicines: Recommendations of preparation, administration and stability

Objetivo: Elaborar unas recomendaciones de preparación de medicamentos de administración parenteral (MAP) para valorarla posibilidad de transferir su preparación, desde las unidades de enfermería en planta de hospitalización al servicio de farmacia (SF).Método: Se procede a elaborar una tabla de estabilidades delos medicamentos incluidos en la guía farmacoterapéutica del Hospital, aplicando la Guía USP (Pharmaceutical compounding Sterile Preparations) y la Guía de buenas prácticas de preparación de medicamentos en los servicios de farmacia hospitalaria. Se recopiló información sobre las MAP: método de preparación, compatibilidad, conservación, período de validez, modo de administración y tipo de envase. Los datos se obtuvieron mediante consulta de las fichas técnicas, laboratorios, revisión bibliográfica y otras bases de datos. Resultados: Tras revisar 209 fármacos se elaboró un listado de recomendaciones. Según los datos obtenidos, las MAP se prepararán de la siguiente forma: 89 serán preparadas desde el SF,62 en unidad de enfermería en planta de hospitalización pues son medicamentos que requieren administración inmediata y 58 ya van acondicionados para su administración por la industria. De los 62 fármacos que se prepararán por enfermería, en 14 de ellos las dosis siguientes se prepararán desde el SF. Por lo tanto de los 209 fármacos sólo 48 se prepararán exclusivamente en la unidad de enfermería. Conclusiones: Desde el SF se ha establecido un método normalizado de preparación, conservación, administración y período de validez de MAP. La preparación de MAP en SF ampliaría su tiempo de conservación, al tener en cuenta la estabilidad fisicoquímica, el nivel de riesgo y la vulnerabilidad del preparado a la contaminación microbiológica. La información aportada contribuirá a una disminución de errores asociados al proceso de preparación y administración de MAP

Objective: To develop recommendations for the preparation of parenteral drugs (MAP), to assess the transferability of their preparation, from nursing units in the hospital ward to the pharmacy service (SF).Method: A table of stabilities of parenteral drugs included in the pharmacotherapeutic guideline was developed using the american and spanish guidelines. Information about MAP was collected (method of preparation, support, maintenance, validity, administration specifications and packaging) by consulting product technical sheets, pharmaceutical industries, literature review and databases. Results: After reviewing 209 drugs, a list of recommendations was developed. According to the data, MAP will be prepared as follows: 89 drugs will be prepared from SF, 62 drugs at nursing units because of its immediate administration requirement and 58 are already packed for its administration by the industry. Of these 62 drugs prepared a nursing units, 14 of them will be prepared in the following doses by the SF. Therefore, 48 drugs will be prepared at nursing units from the 209 parenteral drugs reviewed. Conclusions: A standardized method of preparation, storage, administration and validity of MAP was established by the SF. The preparation of MAP in the SF extends its shelf life, by considering physicochemical stability, level of risk and product vulnerability to microbiological contamination. The information provided will contribute to a reduction of errors associated with the preparation and administration of MAP

Recomendaciones de conservación y período de validez de los envases multidosis tras su apertura / Recommendations for the preservation and good-for-use period of multi-dose containers after being opened

Objetivo: El objetivo de este trabajo es establecer un procedimiento normalizado de utilización y conservación de fármacos, dietoterápicos y productos cosméticos en envases multidosis. Método: Se procede a elaborar una tabla resumen de los fármacos, dietoterápicos y productos cosméticos incluidos en la guía farmacoterapéutica del hospital disponibles en envases multidosis y se recopilan informaciones de conservación y período de validez de los ítems seleccionados mediante consulta a las fichas técnicas de los productos, consulta a laboratorios o revisión bibliográfica. Resultados: Se ha revisado un total de 205 envases multidosis incluídos en la Guía Farmacoterapéutica (GFT) del Hospital. Se ha elaborado un procedimiento normalizado de trabajo con instrucciones generales y tabla de recomendaciones para los casos de no disponer de información. Conclusiones: En conclusión, con el presente estudio se facilita información sobre el período de validez y conservación de los envases multidosis tras su apertura. Esta información deberá mantenerse siempre disponible y actualizada (AU)

Objective: The aim of this work is to establish the standard procedure for use and preservation of drugs, dietary products and cosmetic products in multi-dose containers. Method: A summary table containing all the drugs, dietary and cosmetic products included in the hospital vademecum available in multi-dose containers was elaborated and information on preservation and good-for-use periods was gathered from the products technical sheets, consultation to the pharmaceuticals companies, and literature search. Results: 205 pharmaceutical specialties and magisterial formulations elaborated at the hospital were reviewed. A standardized working procedure was created with general instructions and a table of recommendations in case of missing information. Conclusions: with the present study, the information on the good-for-use period and preservation of multi-dose containers after being opened is improved. This information should always be kept available and updated (AU)

[Recommendations for the preservation and good-for-use period of multi-dose containers after being opened]. / Recomendaciones de conservación y período de validez de los envases multidosis tras su apertura.

OBJECTIVE: The aim of this work is to establish the standard procedure for use and preservation of drugs, dietary products and cosmetic products in multi-dose containers. METHOD: a summary table containing all the drugs, dietary and cosmetic products included in the hospital vademecum available in multi-dose containers was elaborated and information on preservation and good-for-use periods was gathered from the products technical sheets, consultation to the pharmaceuticals companies, and lite rature search. RESULTS: 205 pharmaceutical specialties and magisterial formulations elaborated at the hospital were reviewed. A standardized working procedure was created with general instructions and a table of recommendations in case of missing information. CONCLUSIONS: with the present study, the information on the good-for-use period and preservation of multi-dose containers after being opened is improved. This information should always be kept available and updated.

Objetivo: El objetivo de este trabajo es establecer un procedimiento normalizado de utilización y conservación de fármacos, dietoterápicos y productos cosméticos en envases multidosis. Método: Se procede a elaborar una tabla resumen de los fármacos, dietoterápicos y productos cosméticos incluidos en la guía farmacoterapéutica del hospital disponibles en envases multidosis y se recopilan informaciones de conservación y perío - do de validez de los ítems seleccionados mediante consulta a las fichas técnicas de los productos, consulta a laboratorios o revisión bibliográfica. Resultados: Se ha revisado un total de 205 envases multidosis incluídos en la Guía Farmacoterapéutica (GFT) del Hospital. Se ha elaborado un procedimiento normalizado de trabajo con instrucciones generales y tabla de recomendaciones para los casos de no disponer de información. Conclusiones: En conclusión, con el presente estudio se facilita información sobre el período de validez y conservación de los envases multidosis tras su apertura. Esta información deberá mantenerse siempre disponible y actualizada.

Optimización de la farmacoterapia en un hospital de Traumatología / Optimisation of pharmacotherapy in a trauma centre

Objetivo Evaluar los resultados de la implantación de un programa de atención farmacéutica dirigido a optimizar el tratamiento farmacoterapéutico individualizado en un hospital de Traumatología con historia clínica informatizada (HCI) y sistema integral de dispensación individualizada de medicamentos (SIDIM).Métodos Estudio retrospectivo observacional de 3 años de duración (2007-2009). Se realizó un seguimiento diario del tratamiento farmacoterapéutico de los pacientes ingresados en unidades de hospitalización con SIDIM. Mediante el registro en un documento normalizado, se clasificaron los problemas relacionados con los medicamentos (PRM) y/o errores de medicación (EM) identificados, así como las intervenciones farmacéuticas realizadas de acuerdo con la idoneidad y el grado de aceptación de las mismas. Para la identificación de pacientes con oportunidades de mejora en su farmacoterapia (PRM y/o EM) se empleó el método IASER®.Resultados Se realizaron 1.971 intervenciones farmacéuticas (IF) tras revisar 124.336 líneas de tratamiento correspondientes a 12 IF por cada 100 pacientes. La prevalencia de pacientes con PRM fue del 12% distribuidos de la siguiente manera: 50,66% categorizados en seguridad, 22,98% en indicación, 12,23% en efectividad y 14,13% en adherencia. Los grupos fármacológicos principalmente implicados fueron: antiinfecciosos (29%), fármacos para el aparato locomotor (..) (AU)

Objective To evaluate the results for implementing a pharmaceutical care programme aimed at optimising personalised pharmacotherapeutic treatment in a Trauma Centre with electronic medical records (EMR) and an integral system for personalised medication dispensing (ISPMD).Method A three-year observational, retrospective study (2007-2009). On a daily basis, we checked the pharmaceutical treatment of patients admitted to hospital units with ISPMD. The medication-related problems (MRP) and medication errors (ME) were identified and classified by recording them on a standardised document. We also recorded data on the Pharmaceutical Interventions performed in accordance with fitness and level of acceptance. We used the laser® method to identify patients with pharmacotherapy improvement opportunities (MRP and/or ME).Results One thousand nine-hundred and seventy-one pharmaceutical interventions (PI) were found after having reviewed 124 336 treatment lines, resulting in 12 PI for every 100 patients. The prevalence of patients with MRP was 12%, distributed as such: 50.66% were safety-related, 22.98% indication-related, 12.23% effectiveness-related and 14.13% adherence-related. The main drug groups involved were: anti-infectious agents (29%), drugs for the musculoskeletal system (21%), drugs for blood and haematopoietic organs (12%), and drugs for the nervous system (11%). The active ingredient that required most PI in 2007 was dexketoprofen (15.6%), followed by ketorolac (12.4%). In 2008, it was dexketoprofen (22.0%) followed by gentamicin (7.3%), and in 2009 enoxaparin (19.0%) followed by dexketoprofen (14.3%). The origin of MRP was due to ME in 91% of cases in 2007and 81% in 2008, decreasing (..) (AU)

[Optimisation of pharmacotherapy in a trauma centre]. / Optimización de la farmacoterapia en un hospital de Traumatología.

OBJECTIVE: To evaluate the results for implementing a pharmaceutical care programme aimed at optimising personalised pharmacotherapeutic treatment in a Trauma Centre with electronic medical records (EMR) and an integral system for personalised medication dispensing (ISPMD). METHOD: A three-year observational, retrospective study (2007-2009). On a daily basis, we checked the pharmaceutical treatment of patients admitted to hospital units with ISPMD. The medication-related problems (MRP) and medication errors (ME) were identified and classified by recording them on a standardised document. We also recorded data on the Pharmaceutical Interventions performed in accordance with fitness and level of acceptance. We used the laser method to identify patients with pharmacotherapy improvement opportunities (MRP and/or ME). RESULTS: One thousand nine-hundred and seventy-one pharmaceutical interventions (PI) were found after having reviewed 124 336 treatment lines, resulting in 12 PI for every 100 patients. The prevalence of patients with MRP was 12%, distributed as such: 50.66% were safety-related, 22.98% indication-related, 12.23% effectiveness-related and 14.13% adherence-related. The main drug groups involved were: anti-infectious agents (29%), drugs for the musculoskeletal system (21%), drugs for blood and haematopoietic organs (12%), and drugs for the nervous system (11%). The active ingredient that required most PI in 2007 was dexketoprofen (15.6%), followed by ketorolac (12.4%). In 2008, it was dexketoprofen (22.0%) followed by gentamicin (7.3%), and in 2009 enoxaparin (19.0%) followed by dexketoprofen (14.3%). The origin of MRP was due to ME in 91% of cases in 2007 and 81% in 2008, decreasing to 53% in 2009. PI fitness, as percentages (CI 95%) were considered: Important PI [30.29 (10.19-49.95)]; Very important PI [38.36 (35.45-73)]; Acceptable PI [82.10 (52.28-111.10)]. CONCLUSIONS: Optimising personalised pharmacotherapeutic treatment by implementing an interdisciplinary Pharmaceutical Care programme promotes team work, and as a result improves rational and safe medication dispensing.