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.

PAUSATE Study: Prevalence and appropriateness of the use of antimicrobials in Spanish hospitals.

OBJECTIVE: To determine the prevalence and appropriateness of antimicrobial use in Spanish hospitals through a pharmacist-led systematic cross-sectional review. METHOD: A nationwide multicenter cross-sectional study was conducted on  10% of the patients admitted to the participating hospitals on one day in April  2021. Hospital participation was voluntary, and the population was randomly  selected. The study sample was made up of patients who, on the day of the  study, received at least one antimicrobial belonging to groups J01, J02, J04,  J05AB, J05AD or J05AH in the Anatomical Therapeutic Chemical Classification  System. The pharmacist in charge made a record and carried out an evaluation  of the appropriateness of antimicrobial use following a method  proposed and validated by the Pharmaceutical Care of Patients with Infectious  Diseases Working Group of the Spanish Society of Hospital Pharmacy. The  evaluation method considered each of the items comprising antimicrobial  prescriptions. An algorithm was used to assess prescriptions as appropriate,  suboptimal, inappropriate and unevaluableResults: One-hundred three hospitals participated in the study and the treatment of 3,568 patients was reviewed. A total of 1,498 (42.0%) patients received antimicrobial therapy, 424 (28.3%) of them in  combination therapy. The most commonly prescribed antimicrobials were  moxicillin-clavulanic acid (7.2%), ceftriaxone (6.4%), piperacillin-tazobactam  (5.8%), and meropenem 4.0%. As regards appropriateness,  prescriptions were considered appropriate in 34% of cases, suboptimal in 45%,  inappropriate in 19% and unevaluable in 2%. The items that most  influenced the assessment of a prescription as suboptimal were completeness  f medical record entries, choice of agent, duration of treatment and monitoring of efficacy and safety. The item that most influences the  assessment of a prescription as inappropriate was the indication of  ntimicrobial agent. Conclusions: The method used provided information on the prevalence and  appropriateness of the use of antimicrobials, a preliminary step in the design  and implementation of actions aimed at measuring the impact of the use of  ntimicrobials within the antimicrobial stewardship programs.

OBJETIVO: Conocer la prevalencia y el grado de adecuación del uso de  antimicrobianos en los hospitales españoles mediante una revisión sistemática  transversal realizada por farmacéuticos.Método: Estudio multicéntrico, nacional, transversal sobre el 10% de los pacientes ingresados en los hospitales participantes un día del mes de abril  de 2021. La participación de los hospitales fue voluntaria y la selección de la  población aleatoria. De la población se disgregó la muestra de estudio,  constituida por los pacientes que recibían el día del corte al menos un  antimicrobiano perteneciente a los grupos J01, J02, J04, J05AB, J05AD y  J05AH del Sistema de Clasificación Anatómica, Terapéutica y Química. Sobre la  muestra de estudio, el farmacéutico realizó un registro y evaluación de la  adecuación del tratamiento antimicrobiano siguiendo una metódica propuesta y  validada por el Grupo de trabajo de Atención Farmacéutica al Paciente con  nfermedad Infecciosa de la Sociedad Española de Farmacia Hospitalaria. La  metódica de evaluación consideró cada una de las dimensiones que conforman  la prescripción del antimicrobiano e incluyó un algoritmo para calificar la  prescripción global como adecuada, mejorable, inadecuada y no valorable. RESULTADOS: Participaron 103 hospitales y se revisó el tratamiento de 3.568  pacientes, de los que 1.498 (42,0%) recibieron terapia antimicrobiana, 424  (28,3%) en combinación. La prevalencia de los antimicrobianos más frecuentes  fue: amoxicilina-clavulánico 7,2%, ceftriaxona 6,4%, piperacilina- tazobactam 5,8% y meropenem 4,0%. Respecto a la adecuación del  tratamiento la prescripción, fue considerada adecuada en el 34% de los casos,  mejorable en el 45%, inadecuada en el 19% y no valorable en el 2%. Las  dimensiones que más influyeron en la calificación de la prescripción como  mejorable fueron el registro en la historia clínica, la elección del agente, la  duración del tratamiento y la monitorización de la eficacia y seguridad, y como  inadecuada la indicación de antimicrobiano. CONCLUSIONES: La metódica utilizada permite conocer la prevalencia y  adecuación del uso de antimicrobianos, paso previo para diseñar y emprender  acciones de mejora y medir el impacto de su implantación en el marco de los  programas de optimización del uso de antimicrobianos.

Estudio PAUSATE: Prevalencia y adecuación del uso hospitalario de antimicrobianos en España / PAUSATE Study: Prevalence and appropriateness of the use of antimicrobials in Spanish hospitals

Objetivo: Conocer la prevalencia y el grado de adecuación del usode antimicrobianos en los hospitales españoles mediante una revisiónsistemática transversal realizada por farmacéuticos.Método: Estudio multicéntrico, nacional, transversal sobre el 10% de lospacientes ingresados en los hospitales participantes un día del mes deabril de 2021. La participación de los hospitales fue voluntaria y la selección de la población aleatoria. De la población se disgregó la muestrade estudio, constituida por los pacientes que recibían el día del corte almenos un antimicrobiano perteneciente a los grupos J01, J02, J04, J05AB,J05AD y J05AH del Sistema de Clasificación Anatómica, Terapéutica yQuímica. Sobre la muestra de estudio, el farmacéutico realizó un registroy evaluación de la adecuación del tratamiento antimicrobiano siguiendouna metódica propuesta y validada por el Grupo de trabajo de AtenciónFarmacéutica al Paciente con Enfermedad Infecciosa de la Sociedad Española de Farmacia Hospitalaria. La metódica de evaluación consideró cadauna de las dimensiones que conforman la prescripción del antimicrobiano eincluyó un algoritmo para calificar la prescripción global como adecuada,mejorable, inadecuada y no valorable. (AU)

Objective: To determine the prevalence and appropriateness of antimicrobial use in Spanish hospitals through a pharmacist-led systematiccross-sectional review.Method: A nationwide multicenter cross-sectional study was conductedon 10% of the patients admitted to the participating hospitals on one dayin April 2021. Hospital participation was voluntary, and the populationwas randomly selected. The study sample was made up of patients who,on the day of the study, received at least one antimicrobial belonging togroups J01, J02, J04, J05AB, J05AD or J05AH in the Anatomical Therapeutic Chemical Classification System. The pharmacist in charge madea record and carried out an evaluation of the appropriateness of antimicrobial use following a method proposed and validated by the Pharmaceutical Care of Patients with Infectious Diseases Working Group of theSpanish Society of Hospital Pharmacy. The evaluation method consideredeach of the items comprising antimicrobial prescriptions. An algorithm wasused to assess prescriptions as appropriate, suboptimal, inappropriateand unevaluable. (AU)