How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice.

Biopharmaceuticals are complex biological molecules that require careful storage and handling to ensure medication integrity. In this study, a work system analysis of real-world protein drug (PD) handling was performed with the following goals: identify main barriers and facilitators for successful adherence to accepted recommendations in PD handling, analyse differences in two organizations, and define a Best Current Practice in the real-life handling of PDs based on the results of the work system analysis. Observational study was held in two university hospitals in Spain and Sweden. Based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, the tools chosen were: the PETT scan, in order to indicate the presence of barriers or facilitators for the PETT components (People, Environment, Tools, Tasks); the Tasks and tools matrices to construct a checklist to record direct observations during the real-life handling of biopharmaceuticals, and the Journey map to depict the work process. Observations were performed between March and November 2022. Each episode of direct observation included a single protein drug in some point of the supply chain and considered all the elements in the work system. Based on the results of the work system analysis and the literature review, the authors propose a list of items which could be assumed as Best Current Practice for PDs handling in hospitals. There were a total of 34 observations involving 19 PDs. Regarding People involved in the work process, there was a diversity of professionals with different previous training and knowledge, leading to an information gap. With respect to Environment, some structural and organizational differences between hospitals lead to risks related to the time exposure of PDs to room temperature and mechanical stress. Some differences also existed in the Tools and Tasks involved in the process, being especially relevant to the lack of compatibility information of PDs with new technologies, such as pneumatic tube system, robotic reconstitution, or closed-system transfer devices. Finally, 15 suggestions for best current practice are proposed. Main barriers found for compliance with accepted recommendations were related to the information gap detected in professionals involved in the handling of protein drugs, unmonitored temperature, and the lack of compatibility information of protein drugs with some new technologies. By applying a Human Factors and Systems Engineering Approach, the comparison of two European hospitals has led to a suggested list of Best Current Practices in the handling of protein drugs in a hospital.

Proyecto Trazam: aplicación móvil para la trazabilidad de preparaciones elaboradas en un servicio de farmacia / Trazam project: A mobile application for the tracking of compounded preparations in a Pharmacy Department

Introducción el objetivo principal es describir el diseño e implementación de una aplicación para dispositivos móviles para facilitar el seguimiento de las preparaciones elaboradas en el servicio de farmacia hospitalaria. Los objetivos secundarios fueron evaluar el tiempo dedicado a la resolución de incidencias relacionadas con la dispensación/distribución de las preparaciones pre y postimplantación de la aplicación, conocer el grado de satisfacción de los usuarios y disponer de información cualitativa y cuantitativa del proceso que permita establecer indicadores de seguimiento. Métodos se definieron los requisitos a cumplir por el aplicativo informático, los fármacos susceptibles de entrar en el sistema y los circuitos de entrega. Se procedió al desarrollo de la aplicación por parte del proveedor e integración con los programas informáticos de prescripción/validación. Se crearon y añadieron los códigos QR de identificación en los puntos de entrega de medicamentos en las unidades de destino. Se adquirieron los dispositivos móviles necesarios. Primera etapa de formación de usuarios en la aplicación y prueba piloto en una planta de hospitalización. Posteriormente se inició la fase de expansión y consolidación. Resultados el 86,9% de las preparaciones estériles elaboradas en el servicio de farmacia hospitalaria se han incorporado al sistema, incluyendo quimioterapia, nutriciones parenterales de adultos y otras preparaciones estériles no peligrosas. Se han incluido en la aplicación las salas de hospitalización, los hospitales de día y 2 sedes externas. La media de preparaciones trazadas mensualmente es de 5.403 (DE = 297,3) (AU)

Introduction The primary objective of this study is to describe the design and implementation of a mobile application (App) for tracking preparations compounded in the Pharmacy Department. Secondary objectives include evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, assessing users satisfaction with the application, and establishing a panel of quality indicators based on the data extracted from the App. Methods Defining application requirements, identifying drugs to be included in the software and outlining different workflows. Developing the App in collaboration with the supplier and integrating it with the computer programs involved in prescription and validation. Additionally, QR codes were created to identify delivery points at destination units, and suitable mobile devices were acquired. The initial phase involved user training in the application and a pilot test conducted in a hospital ward. The subsequent phase focused on expansion and consolidation. Results The system includes 86.9% of all sterile preparations prepared in the Hospital Pharmacy, encompassing chemotherapy, adult parenteral nutrition, and other non-hazardous sterile preparations. Furthermore, the application has been implemented in all hospitalization wards, day care units and two external sites. On average, 5,403 preparations were tracked per month (SD = 297.3). The time required to address incidents related to the distribution of preparations has decreased by 83% (from 38.9 to 6.6 minutes per day). The App regularly provides valuable management data for optimizing workflow in the compounding area. Additionally, users have expressed satisfaction with the application (AU)

Trazam project: A mobile application for the tracking of compounded preparations in a Pharmacy Department. / Proyecto Trazam: aplicación móvil para la trazabilidad de preparaciones elaboradas en un servicio de farmacia.

INTRODUCTION: The primary objective of this study is to describe the design and implementation of a mobile application (App) for tracking preparations compounded in the Pharmacy Department. Secondary objectives include evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, assessing users satisfaction with the application, and establishing a panel of quality indicators based on the data extracted from the App. METHODS: Defining application requirements, identifying drugs to be included in the software and outlining different workflows. Developing the App in collaboration with the supplier and integrating it with the computer programs involved in prescription and validation. Additionally, QR codes were created to identify delivery points at destination units, and suitable mobile devices were acquired. The initial phase involved user training in the application and a pilot test conducted in a hospital ward. The subsequent phase focused on expansion and consolidation. RESULTS: The system includes 86.9% of all sterile preparations prepared in the Hospital Pharmacy, encompassing chemotherapy, adult parenteral nutrition, and other non-hazardous sterile preparations. Furthermore, the application has been implemented in all hospitalization wards, day care units and two external sites. On average, 5,403 preparations were tracked per month (SD = 297.3). The time required to address incidents related to the distribution of preparations has decreased by 83% (from 38.9 to 6.6 minutes per day). The App regularly provides valuable management data for optimizing workflow in the compounding area. Additionally, users have expressed satisfaction with the application. DISCUSION: The proposed application enables hospital staff to easily and intuitively track preparations compounded in the pharmacy, irrespective of the computer program used for prescription. It has significantly reduced the need for manual record-keeping and has mitigated incidents associated with the distribution of sterile preparations.

Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN / Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project

Objetivo: este estudio corresponde a la primera etapa del proyecto MEDPAIN «Actualización de mezclas analgésicas por vía parenteral: estudios de utilización, compatibilidad y estabilidad», y tiene por objetivo la elaboración de un mapa a nivel nacional del empleo de mezclas analgésicas en los hospitales y los centros sociosanitarios. Material y método estudio transversal, basado en una encuesta dirigida a farmacéuticos hospitalarios, durante el período diciembre 2020 - abril 2021. Se diseñó un cuestionario multirrespuesta en la plataforma RedCap® para su difusión a través de la lista de distribución de la Sociedad Española de Farmacia Hospitalaria. Se definió mezcla analgésica como la combinación de 2 o más principios activos, de los cuales al menos uno es analgésico. Una misma combinación de fármacos a distintas concentraciones, o administrada por diferentes vías, se consideró una misma mezcla a efectos de este estudio. Se registraron variables relacionadas con el centro participante y otras relacionadas con las mezclas analgésicas: composición farmacológica de la mezcla, vía de administración, frecuencia de uso, indicación, tipo de paciente (adulto/pediátrico), ámbito en el que se utiliza (hospitalario/domicilio) y lugar de preparación. Resultados se recibieron un total de 67 encuestas válidas (55,4%) procedentes de 13 comunidades autónomas. Los 67 centros sanitarios comunicaron un total de 462 mezclas analgésicas. La mediana de mezclas informadas por centro participante fue de 6 (RIC p25-p75 = 4,0-9,0). La mayoría de las mezclas notificadas se utilizan en adultos (93,9%) y en el ámbito hospitalario (91,8%); mayoritariamente se trata de mezclas protocolizadas y de uso frecuente. El 21,4% se preparan en el servicio de farmacia. En las mezclas descritas aparecen 26 fármacos distintos; predominan los analgésicos opioides, presentes en el 87,4% de las mezclas. El fármaco coadyuvante más frecuente es el midazolam. ... (AU)

Objetive: This study is the first part of the MEDPAIN project “Update of analgesic parenteral admixtures: studies of use, compatibility and stability”, and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. Methods Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020–April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. Results A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. ... (AU)

[Translated article] Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project.

OBJECTIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020 - April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 = 4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: In conclusion, this study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project. / Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN.

OBJETIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020-April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: This study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Examination of the Protein Drug Supply Chain in a Swedish University Hospital: Focus on Handling Risks and Mitigation Measures.

Protein drugs, such as monoclonal antibodies, have proved successful in treating cancer and immune system diseases. The structural complexity of these molecules requires careful handling to ensure integrity and stability of the drug. In this study, a failure mode and effects analysis was performed based on a Gemba Walk method in a Swedish University Hospital. The Gemba Walk is focused on pharmacists observing the actual supply process steps from distributor, pharmacy cleanroom to patient administration. Relevant protein drugs are chosen based on sales statistics within the hospital and the corresponding wards were observed. Further is the Double Diamond design method used to identify major risks and deliver mitigation strategies. The study identified potential stress factors such as temperature, shock by impact, shaking, vibration and light exposure. There were also risks associated with porters' and healthcare professionals' lack of awareness and access to information. These risk factors may cause loss of efficacy and quality of the protein drug, potentially leading to patient safety concerns. In this study, a simulation is also performed to list measures that theoretically should be in place to ensure the quality of the protein drug, for example validated and protocol-based compounding in cleanroom, training and validated transports.

Treatment of Porokeratosis Ptychotropica With a Topical Combination of Cholesterol and Simvastatin.

This case report describes 2 patients with Ptychotropic porokeratosis who were treated with a combination of cholesterol and simvastatin.

Robotic chemotherapy compounding: A multicenter productivity approach.

INTRODUCTION: The aim of this study is to compare productivity of the KIRO Oncology compounding robot in three hospital pharmacy departments and identify the key factors to predict and optimize automatic compounding time. METHODS: The study was conducted in three hospitals. Each hospital compounding workload and workflow were analyzed. Data from the robotic compounding cycles from August 2017 to July 2018 were retrospectively obtained. Nine cycle specific parameters and five productivity indicators were analysed in each site. One-to-one differences between hospitals were evaluated. Next, a correlation analysis between cycle specific factors and productivity indicators was conducted; the factors presenting a highest correlation to automatic compounding time were used to develop a multiple regression model (afterwards validated) to predict the automatic compounding time. RESULTS: A total of 2795 cycles (16367 preparations) were analysed. Automatic compounding time showed a relevant positive correlation (ǀrs|>0.40) with the number of preparations, number of vials and total volume per cycle. Therefore, these cycle specific parameters were chosen as independent variables for the mathematical model. Considering cycles lasting 40 minutes or less, predictability of the model was high for all three hospitals (R2:0.81; 0.79; 0.72). CONCLUSION: Workflow differences have a remarkable incidence in the global productivity of the automated process. Total volume dosed for all preparations in a cycle is one of the variables with greater influence in automatic compounding time. Algorithms to predict automatic compounding time can be useful to help users in order to plan the cycles launched in KIRO Oncology.

Evaluation of desensitization protocols to betalactam antibiotics.

WHAT IS KNOWN AND OBJECTIVE: Betalactam antibiotics are the most frequent cause of hypersensitivity reactions. Rapid drug desensitization (RDD) is a technique that induces temporary tolerance to a drug allowing a patient to receive the optimal agent. The increased use of RDD and the lack of standardization among available protocols in terms of formulation, starting dose, number of steps and dosing frequency make it essential to determine the safety and appropriate management of these protocols, especially regarding reconstitution, diluents, stability and drug administration in order to guarantee reproducibility. We reviewed betalactam desensitization protocols in a tertiary hospital, in accordance with currently published practices and evaluated its use on patients over a period of three years. METHODS: (a) We performed a literature search in PubMed, MEDLINE and Google Scholar databases for case reports and/or systematic reviews describing desensitization protocols for betalactam antibiotics. Pharmacokinetic parameters and physicochemical stability were checked for each antibiotic. (b) We retrospectively reviewed inpatients undergoing our antibiotic desensitization protocols from February 2018 to January 2021. Data and outcomes of desensitization procedures were analysed. RESULTS: We developed nine RDD protocols: meropenem, ceftriaxone, ceftazidime, ampicillin, ceftolozane/tazobactam, cloxacillin, piperacillin/tazobactam, amoxicillin/clavulanate and penicillin G sodium. Five antibiotics have RDD protocols for two different doses, adjusted to patients with impaired renal function. Detailed data (diluent, total dose, volume, concentrations, duration and stability) of the protocol of each antibiotic used are provided. 28 desensitizations were performed in 17 patients, three of them with confirmed allergies by skin test. 26 out of 28 (92.9%) of them were successfully completed, including those three with positive skin results. The pathogens most frequently involved were E. faecalis and P. aeruginosa; both frequently associated with bacterial resistance. Meropenem, ceftriaxone and ceftazidime were the antibiotics most desensitized. 25 out of 26 (96.1%) procedures were successful in resolving the infection. WHAT IS NEW AND CONCLUSIONS: Detailed information about compounding, dilution and stability is crucial to ensure safe and successful desensitization processes, as well as good coordination between the Allergy and Pharmacy departments. The increase in bacterial resistance to many of the commercially available antibiotics limits the therapeutic options for treating multidrug-resistant infections; in those situations, antibiotic desensitization may be a key therapeutic option. Although there is a broad consensus in limiting the use of RDD to patients with confirmed allergy, in usual clinical practice its application in those strongly suspected of having type I hypersensitivity is still observed. Our betalactam desensitization protocols have shown themselves to be safe and effective, as evidenced by data from the 17 patients on whom they have been tested.

Stability of 5% vancomycin ophthalmic solution prepared using balanced salt solution after freezing for 90 days.

PURPOSE: To evaluate the stability of 5% vancomycin ophthalmic solution prepared using balanced salt solution (BSS) and stored at -20°C in polypropylene containers. METHODS: Six batches of vancomycin 50 mg/mL eyedrops were aseptically prepared. One bottle of each batch was analyzed immediately after preparation, and the rest were stored at -20°C and analyzed using high-performance liquid chromatography (HPLC) at 30, 60, and 90 days to test their physicochemical stability and sterility. Thereafter, bottles were removed from the freezer and stored at 5°C for 30 days, with HPLC and other analyses repeated 105 and 120 days after preparation. All samples were analyzed in triplicate. Stability was defined as the absence of particles, color variation, or changes in pH and a remaining vancomycin concentration of 90% to 110% of the initial concentration. The sterility of the ophthalmic solution was evaluated by using soybean-casein digest broth with resins; samples were incubated for 7 days and checked daily for signs of microbial growth. RESULTS: There was no particle formation or sign of precipitation in any of the solutions throughout the duration of the study, regardless of the storage conditions. No change in color or turbidity was observed. The pH and osmolarity remained unchanged during storage at -20°C and after thawing. The vancomycin concentration remained within 10% of the initial concentration during the 90-day period of storage at -20°C and the subsequent 30 days after thawing. Sterility was preserved in all samples. CONCLUSION: A 5% solution of vancomycin prepared using BSS was physicochemically and microbiologically stable when stored at -20°C for 90 days. After thawing, this extemporaneous formulation remained stable when refrigerated at 5°C for 30 days.

Cleveland Clinic International IV Robotics Summit.

PURPOSE: The proceedings of an international summit on the current and desired future state of use of robotic systems to compound intravenous (IV) solutions are summarized. SUMMARY: The International IV Robotics Summit was held at the Cleveland Clinic main campus in Cleveland, OH, on April 29 and 30, 2019. The purpose of the summit was 2-fold: (1) to define the current state of robotic IV compounding and (2) to develop a guide for automation companies, pharmacy departments, and drug manufacturers to improve the technology and expand the use of IV robotics in health systems in the future. The first day of the summit included 45-minute presentations by each of the speakers. Each lecturer recounted a different hospital's experience implementing and using IV robotics. On day 2 of the summit, an expert panel dedicated to mapping the future of IV robotics was convened to determine barriers to widespread adoption of IV robotics in health systems and offer potential solutions to remove these barriers. The expert panel targeted 3 specific audiences: robot manufacturers, drug manufacturers, and fellow pharmacy leaders. CONCLUSION: It is the hope of the international faculty that the information that emerged from the summit can be used by others to successfully implement IV compounding robotics in their sterile products areas to maximize patient safety. The summit also served as a call to action for pharmacy leaders, drug manufacturers, and robotic companies to develop a safer, more efficient future for patients by working together to optimize the development and operation of IV robotics.

Dose banding of intravenous ganciclovir: Banding scheme proposal and audit of toxicity and efficiency.

WHAT IS KNOWN AND OBJECTIVE: Dose banding is a strategy to optimize processing without reducing patient safety. Prescribed doses are rounded up or down to predetermined standard doses. Although it has been mostly used in chemotherapy, other drugs are suitable for this strategy, such as the antiviral ganciclovir. The aim of this work is to assess the safety and efficiency of a dose-rounding system for intravenous ganciclovir. METHODS: Dose bands were established for a maximum of 10% variation from the individualized dose. The number of annual preparations that expired before use and the number of ganciclovir vials saved were documented as indicators of efficiency. Toxicity was assessed comparing haematological parameters before and after ganciclovir treatment in a sample of patients who received doses above the theoretical dose (n = 121) and in the rest of the cohort (n = 129). RESULTS AND DISCUSSION: Five ganciclovir standard doses were established. It was shown that the bulk of the preparations (83.7%) had a maximum variation between the exact dose prescribed and the adjusted dose of ±10%. Three years after its implementation, a mean of 2848 annual preparations were compounded. The average percentage of annual expired preparations was lower than 1% of the total compounded doses, and the dose-rounding system allowed for saving 699 manufactured ganciclovir vials annually. There was no significant difference between haemoglobin and leucocyte levels measured before and after ganciclovir treatment in both groups. WHAT IS NEW AND CONCLUSION: Ganciclovir dose banding allows for efficient management of preparations without an increased risk of acute haematological side effects.

Hospital Pharmacy Compounding against COVID-19 pandemic.

As in other areas of the health system, COVID-19 has had a dramatic impact on  hospital compounding. This area has faced numerous challenges, including the  shortage of frequent-use products (hydroalcoholic solutions, lopinavir/ritonavir  suspension), the use of new preparations for SARS-CoV-2 (tocilizumab,  remdesivir), or requests from overwhelmed wards unable to assume the safe  preparation of a high volume of medications (intravenous solutions). The  demand for all types of preparations (topic and oral medications, intravenous  solutions) has increased dramatically. This increase has highlighted the shortage of resources allocated to this area, which has made it difficult to meet the high  demand for preparations. In addition, the pandemic has revealed the scarcity of  research on such basic aspects as agent stability and drug compatibility. One of  the most relevant conclusions drawn from the COVID-19 pandemic is that the  basic areas of hospital pharmacy, along with other, must be maintained and  reinforced, as these are the areas that make us essential.

Como todo el sector sanitario, la farmacotecnia hospitalaria ha sufrido el impacto de la pandemia de la COVID-19, enfrentándose a la necesidad de cubrir el  desabastecimiento de productos de uso frecuente (soluciones hidroalcohólicas,  lopinavir/ritonavir suspensión), a nuevas preparaciones surgidas de las nuevas  necesidades provocadas por el SARS-CoV-2 (tocilizumab, remdesivir), o a  peticiones de plantas desbordadas por la carga asistencial, incapaces de asumir  con un mínimo de seguridad la preparación de numerosos medicamentos  (mezclas intravenosas). El incremento de actividad ha sido en todo tipo de  preparados (tópicos, orales y mezclas intravenosas) y ha puesto de manifiesto la escasez de recursos destinados a esta área, que se ha traducido en serios  problemas para afrontar todas las elaboraciones necesarias, así como la falta de  investigación en aspectos tan básicos como la estabilidad o la compatibilidad de  medicamentos. Probablemente, una de las conclusiones más importantes que  podemos extraer tras la COVID-19 es que ­sin menospreciar otras áreas de la  farmacia hospitalaria que también deben desarrollarse­ debemos mantener y  potenciar las áreas básicas de nuestra profesión. Aquellas que nos hacen imprescindibles.

La farmacotecnia hospitalaria frente a la COVID-19 / Hospital Pharmacy Compounding against COVID-19 pandemic

Como todo el sector sanitario, la farmacotecnia hospitalaria ha sufrido el impacto de la pandemia de la COVID-19, enfrentándose a la necesidad de cubrir el desabastecimiento de productos de uso frecuente (soluciones hidroalcohólicas, lopinavir/ritonavir suspensión), a nuevas preparaciones surgidas de las nuevas necesidades provocadas por el SARS-CoV-2 (tocilizumab, remdesivir), o a peticiones de plantas desbordadas por la carga asistencial, incapaces de asumir con un mínimo de seguridad la preparación de numerosos medicamentos (mezclas intravenosas). El incremento de actividad ha sido en todo tipo de preparados (tópicos, orales y mezclas intravenosas) y ha puesto de manifiesto la escasez de recursos destinados a esta área, que se ha traducido en serios problemas para afrontar todas las elaboraciones necesarias, así como la falta de investigación en aspectos tan básicos como la estabilidad o la compatibilidad de medicamentos. Probablemente, una de las conclusiones más importantes que podemos extraer tras la COVID-19 es que -sin menospreciar otras áreas de la farmacia hospitalaria que también deben desarrollarse- debemos mantener y potenciar las áreas básicas de nuestra profesión. Aquellas que nos hacen imprescindibles

As in other areas of the health system, COVID-19 has had a dramatic impact on hospital compounding. This area has faced numerous challenges, including the shortage of frequent-use products (hydroalcoholic solutions, lopinavir/ritonavir suspension), the use of new preparations for SARS-CoV-2 (tocilizumab, remdesivir), or requests from overwhelmed wards unable to assume the safe preparation of a high volume of medications (intravenous solutions). The demand for all types of preparations (topic and oral medications, intravenous solutions) has increased dramatically. This increase has highlighted the shortage of resources allocated to this area, which has made it difficult to meet the high demand for preparations. In addition, the pandemic has revealed the scarcity of research on such basic aspects as agent stability and drug compatibility. One of the most relevant conclusions drawn from the COVID-19 pandemic is that the basic areas of hospital pharmacy, along with other, must be maintained and reinforced, as these are the areas that make us essential

Análisis bioquímico como método eficiente para aumentar la seguridad de la nutrición parenteral en neonatos / Biochemical test as an efficient system to improve safety in parenteral nutrition for premature infants

Objetivo: Se describe el proceso de validación del control bioquímico de las bolsas de nutrición parenteral para verificar la correcta composición de ingredientes críticos antes de la administración, así como su impacto en la seguridad tras dos años desde la implantación en una población de recién nacidos prematuros. Método: Para la validación de la técnica se usaron 35 muestras de nutrición parenteral sin lípidos, que se procesaron en el laboratorio de Urgencias, siguiendo los procedimientos rutinarios utilizados para medir las concentraciones de glucosa y electrolitos en plasma y orina. Para analizar su impacto en la seguridad se realizaron análisis pre y post implantación mediante análisis modal de falla, efectos y criticidad. También se evaluaron los resultados fuera de rango y sus potenciales repercusiones en la seguridad del paciente. Resultados: El análisis de regresión no muestra error sistemático de medida para glucosa, calcio y potasio; en cambio, para el sodio y el magnesio sí existe un error sistemático, por lo que ambos fueron descartados para los análisis rutinarios. Los resultados del análisis modal de fallos y efectos, atribuibles a la implantación del control bioquímico, mostraron una disminución del riesgo del proceso del 11%. Se analizaron 1.734 nutriciones, correspondientes a 218 neonatos prematuros; se encontraron 58 (3,3%) resultados fuera del rango de aceptación, de los cuales 7 se consideraron errores de preparación potencialmente peligrosos. Conclusiones: El control bioquímico de glucosa y electrolitos es un método eficiente y reproducible que evita que posibles errores de preparación afecten al paciente

Objective: The biochemical test validation process of parenteral nutrition bags is described to verify the correct composition of critical compounds before its administration, as well as its impact on safety after two years since its implantation in a population of premature infants. Method: For the validation of the technique, 35 samples of parenteral nutrition without lipids were processed by the emergency laboratory, following the routine procedures used to measure the concentrations of glucose and electrolytes in plasma and urine. To analyze its impact on safety, pre-implantation and post-implantation risk analysis was carried out using failure mode, effects and criticality analysis (FMECA). Likewise, all out-of-range results and their potential repercussions on patient safety were evaluated. Results: Regression analysis showed no systematic measurement error for glucose, calcium and potassium; however, there is a constant systematic error for sodium and magnesium, thus both were discarded for routine analysis. Failure mode, effects and criticality analysis results showed a decrease in the risk of the process of 11% for the biochemical test. We tested 1,734 parenteral nutritions from 218 premature neonates; 58 (3.3%) results were out of the acceptance range, and 7 were considered to be potentially dangerous compounding errors. Conclusions: The biochemical test of glucose and electrolytes is an efficient and reproducible method that prevents possible compounding errors from reaching the patient

Biochemical test as an efficient system to improve safety in parenteral nutrition for premature infants.

OBJECTIVE: The biochemical test validation process of parenteral nutrition bags  is described to verify the correct composition of critical compounds before its  administration, as well as its impact on safety after two years since its  implantation in a population of premature infants. METHOD: For the validation of the technique, 35 samples of parenteral nutrition  without lipids were processed by the emergency laboratory, following the routine procedures used to measure the concentrations of glucose and electrolytes in  plasma and urine. To analyze its impact on safety, pre-implantation and post- implantation risk analysis was carried out using failure mode, effects and  criticality analysis (FMECA). Likewise, all out-of-range results and their potential  repercussions on patient safety were evaluated. RESULTS: Regression analysis showed no systematic measurement error for  glucose, calcium and potassium; however, there is a constant systematic error  for sodium and magnesium, thus both were discarded for routine analysis.  Failure mode, effects and criticality analysis results showed a decrease in the  risk of the process of 11% for the biochemical test. We tested 1,734 parenteral  nutritions from 218 premature neonates; 58 (3.3%) results were out of the  acceptance range, and 7 were considered to be potentially dangerous  compounding errors. CONCLUSIONS: The biochemical test of glucose and electrolytes is an efficient and reproducible method that prevents possible compounding errors from reaching  the patient.

Objetivo: Se describe el proceso de validación del control bioquímico de las  bolsas de nutrición parenteral para verificar la correcta composición de  ingredientes críticos antes de la administración, así como su impacto en la  seguridad tras dos años desde la implantación en una población de recién  nacidos prematuros.Método: Para la validación de la técnica se usaron 35 muestras de nutrición  parenteral sin lípidos, que se procesaron en el laboratorio de Urgencias,  siguiendo los procedimientos rutinarios utilizados para medir las concentraciones  de glucosa y electrolitos en plasma y orina. Para analizar su  impacto en la seguridad se realizaron análisis pre y post implantación mediante  análisis modal de falla, efectos y criticidad. También se evaluaron los resultados  fuera de rango y sus potenciales repercusiones en la seguridad del paciente.Resultados: El análisis de regresión no muestra error sistemático de medida  para glucosa, calcio y potasio; en cambio, para el sodio y el magnesio sí existe  un error sistemático, por lo que ambos fueron descartados para los análisis  rutinarios. Los resultados del análisis modal de fallos y efectos, atribuibles a la  implantación del control bioquímico, mostraron una disminución del riesgo del  proceso del 11%. Se analizaron 1.734 nutriciones, correspondientes a 218  neonatos prematuros; se encontraron 58 (3,3%) resultados fuera del rango de  aceptación, de los cuales 7 se consideraron errores de preparación  potencialmente peligrosos.Conclusiones: El control bioquímico de glucosa y electrolitos es un método  eficiente y reproducible que evita que posibles errores de preparación afecten al  paciente.

Consenso SEO-SEFH sobre recomendaciones de utilización y elaboración de preparaciones oftálmicas / Consensus SEO-SEFH of recommendations for use and compounding of ophthalmic preparations

Son muchos los medicamentos que, aun habiendo demostrado eficacia y seguridad en diferentes indicaciones oftalmológicas, no están autorizados ni disponibles comercialmente en una forma adecuada para esta vía de administración. Esto implica, por un lado, que se deban utilizar según la legislación que regula la disponibilidad de medicamentos en situaciones especiales y, por otro, que se deban preparar en los Servicios de Farmacia para su administración por vía oftálmica, conforme a unos criterios de calidad que aseguren su efectividad, estabilidad y esterilidad. Este documento recoge un consenso entre la Sociedad Española de Oftalmología y la Sociedad Española de Farmacia Hospitalaria sobre aquellas preparaciones con suficiente evidencia respecto a su eficacia y seguridad para su uso no autorizado en indicaciones y vía de administración oftálmicas. Se incluyen recomendaciones para su utilización de acuerdo con la legislación vigente. Además, con el ánimo de armonizar la preparación de inyecciones intraoculares en los Servicios de Farmacia Hospitalaria, se establecen unas recomendaciones generales para su elaboración siguiendo los estándares establecidos en la Guía de Buenas Prácticas de Preparación de Medicamentos en los Servicios de Farmacia Hospitalaria. En estas recomendaciones se incluyen apartados como el lugar de preparación, el material, la técnica, el envasado, el periodo de validez, el control de calidad, la prescripción y la trazabilidad de las preparaciones intraoculares (AU)

There are many medicinal products that, although having shown efficacy and safety in different ophthalmological indications, they are not authorized or commercially available for ophthalmic administration. This implies, on one hand, that they must be used according to legislation that regulates the availability of medicines in special situations and, on the other hand, that they must be prepared in the pharmacy services for ophthalmic administration, according to quality criteria to ensure its effectiveness, stability and sterility. This document gathers the consensus between the Spanish Society of Ophthalmology and the Spanish Society of Hospital Pharmacy about these selected preparations which have shown enough evidence in their efficacy and safety for their ophthalmic use (off label) and ophthalmic administration. This document includes recommendations about its use according to the current legislation. In addition, with the aim of harmonizing the preparation of intraocular injections in the hospital pharmacy services, general recommendations are set in this document to ensure the compliance with standards established in the Spanish Guideline for Good Preparation Practices of Medicinal Products in Hospital Pharmacies. These recommendations include sections such as the area of preparation, material, technique, packaging, stability, quality control, prescription and traceability of intraocular preparations (AU)

Consensus SEO-SEFH of recommendations for use and compounding of ophthalmic preparations.

There are many medicinal products that, although having shown efficacy and  safety in different ophthalmological indications, they are not authorized or  commercially available for ophthalmic administration. This implies, on one hand,  that they must be used according to legislation that regulates the availability of  medicines in special situations and, on the other hand, that they must be  prepared in the pharmacy services for ophthalmic administration, according to  quality criteria to ensure its effectiveness, stability and sterility. This document  gathers the consensus between the Spanish Society of Ophthalmology and the  Spanish Society of Hospital Pharmacy about these selected preparations which  have shown enough evidence in their efficacy and safety for their ophthalmic use (off label) and ophthalmic administration. This document includes  recommendations about its use according to the current legislation. In addition,  with the aim of harmonizing the preparation of intraocular injections in the  hospital pharmacy services, general recommendations are set in this document  to ensure the compliance with standards established in the Spanish Guideline for Good Preparation Practices of Medicinal Products in Hospital Pharmacies. These  recommendations include sections such as the area of preparation, material,  technique, packaging, stability, quality control, prescription and traceability of  intraocular preparations.

Son muchos los medicamentos que, aun habiendo demostrado eficacia y seguridad en diferentes indicaciones oftalmológicas, no están autorizados ni disponibles comercialmente en una forma adecuada para esta vía de  administración.Esto implica, por un lado, que se deban utilizar según la legislación que regula la disponibilidad de medicamentos en situaciones especiales y, por otro, que se  deban preparar en los Servicios de Farmacia para su administración por vía  oftálmica, conforme a unos criterios de calidad que aseguren su efectividad,  estabilidad y esterilidad. Este documento recoge un consenso entre la Sociedad  Española de Oftalmología y la Sociedad Española de Farmacia Hospitalaria sobre  aquellas preparaciones con suficiente evidencia respecto a su eficacia y  seguridad para su uso no autorizado en indicaciones y vía de administración  oftálmicas. Se incluyen recomendaciones para su utilización de acuerdo con la  legislación vigente. Además, con el ánimo de armonizar la preparación de  inyecciones intraoculares en los Servicios de Farmacia Hospitalaria, se  establecen unas recomendaciones generales para su elaboración siguiendo los  estándares establecidos en la Guía de Buenas Prácticas de Preparación de  Medicamentos en los Servicios de Farmacia Hospitalaria. En estas  recomendaciones se incluyen apartados como el lugar de preparación, el  material, la técnica, el envasado, el periodo de validez, el control de calidad, la  prescripción y la trazabilidad de las preparaciones intraoculares.