Interrupções e distrações durante a preparação e administração de medicamentos de alto risco: Estudo transversal / Interruptions and distractions during the preparation and administration of high-risk medications: A cross-sectional study / Distracciones e interrupciones durante la preparación y administración de medicamentos de alto riesgo: Estudio transversal

Resumo Enquadramento: Estudos indicam que as interrupções contribuem para erros clínicos e falhas em procedimentos. Objetivo: Analisar as interrupções vivenciadas pelos enfermeiros durante a preparação e administração de medicamentos de alto risco. Metodologia: Foi realizado um estudo transversal numa unidade de cuidados intensivos e numa unidade de internamento. As interrupções vivenciadas pelos enfermeiros durante o processo de medicação foram observadas com a ajuda de duas checklists. A amostra foi selecionada por conveniência em abril e maio de 2019. Os dados quantitativos foram analisados através de estatística descritiva no programa IBM SPSS Statistics, versão 24.0, enquanto os dados qualitativos foram tratados por meio da análise de conteúdo. Resultados: Observaram-se 137 interrupções em 193 processos de medicação. A maioria das interrupções foi iniciada por outros membros da equipa de cuidados de saúde por meio de conversas. Estas interrupções foram maioritariamente prejudiciais e ocorreram durante a fase de preparação. A estratégia multitarefa foi utilizada para as gerir. Conclusão: As interrupções ocorridas durante o processo de medicação eram maioritariamente associadas com comunicações profissionais e sociais. A sua relevância diferiu consoante a fase do processo.

Abstract Background: Interruptions have been reported to contribute to clinical errors and procedural failures. Objective: To analyze the interruptions experienced by nurses during the preparation and administration of high-risk medications. Methodology: A cross-sectional study was conducted in an intensive care and inpatient unit. The interruptions experienced by nurses during the medication process were observed through two checklists. The sample was selected by convenience in April-May 2019. Descriptive statistics was used to analyze quantitative data in IBM SPSS Statistics software, version 24.0, while content analysis was used to analyze qualitative data. Results: In 193 medication processes, there were 137 interruptions. Other members of the healthcare team initiated most interruptions through conversations. These interruptions were mostly negative and occurred during the preparation phase. The multitasking strategy was used to manage them. Conclusion: Interruptions during the medication process were primarily associated with professional and social communications. The impact of these interruptions varied depending on the phase of the process.

Resumen Marco contextual: Se ha reportado la participación de distracciones en errores clínicos y fallos de procedimiento. Objetivo: Analizar las distracciones del personal de enfermería durante la preparación y administración de fármacos de alto riesgo. Metodología: Estudio transversal desarrollado en una unidad de cuidados intensivos y una unidad de hospitalización. Se observaron distracciones del personal de enfermería durante el proceso de medicación a través de dos listas de control. La muestra fue seleccionada por conveniencia (abril-mayo 2019). Los datos cuantitativos se analizaron mediante estadística descriptiva (IBM SPSS Statistics, versión 24.0). Los datos cualitativos se analizaron mediante análisis de contenido. Resultados: Hubo 137 distracciones en 193 procesos de medicación. La mayoría de las distracciones fueron iniciadas por otros miembros del equipo sanitario a través de conversaciones. La mayoría se produjeron en la fase de preparación y fueron negativas y se gestionaron mediante la estrategia multitarea. Conclusión: Las distracciones durante el proceso de medicación se referían principalmente a las comunicaciones profesionales y sociales. La importancia de esas distracciones variaba en función de la fase del proceso.

High-risk pediatric medications: A listing proposal by interdisciplinary consensus technique. / Medicación pediátrica de alto riesgo: propuesta de listado a través de la técnica de consenso interdisciplinar.

INTRODUCTION: Pediatric patients are more likely to experience medication-related errors and serious associated harms. The identification of high-risk medications (HRM) and their study in special populations, such as children with excess body weight, is a part of safety improvement strategies. OBJECTIVE: To generate, through a consensus technique structured by an interdisciplinary group of pediatricians and hospital pharmacists, an operational and updated list of HRM for hospital use in children over 2 years of age. The document was part of a collaboration project between the Spanish Society of Hospital Pharmacists and the Spanish Society of Pediatric Hospital Medicine. METHODS: The study was carried out in two sequential phases: a) preparation of a preliminary list of HRM through bibliographic review and b) subsequent application of the double-round Delphi method to agree on a definitive list of HRM. The results obtained were validated by calculating the probability of chance agreement and the modified Kappa statistic for each drug. RESULTS: The original list obtained by bibliographic review included 26 pharmacological classes and 96 drugs. Of the total of 37 experts, 32 (86.4%) completed both rounds of the Delphi. The final consensus list of HRM incorporated 24 pharmacological classes and 100 drugs. The modified Kappa statistic reflected a high percent agreement (94.9%) in the consensus reached by the participants. CONCLUSION: This list can establish a tool for future studies and interventions to improve the safety of medications in general pediatric population, as well as in high-risk subgroups, such as pediatric patients with excess body weight.

Analysis of medication errors in Neonatal Intensive Care: A systematic review.

Medication errors, potentially causing harm and causing harm, increase significantly in newborns cared for in intensive care settings. In this sense, this work carries out a systematic review to analyze the most current evidence in relation to medication errors in neonatal intensive care, discussing the topics that refer to health technology from smart pumps, cost-effectiveness of medications, the practice of nursing professionals on the medication administration process and quality improvement models. In this way, it could be considered a useful tool to promote quality and safety in neonatal intensive care.

Evaluation of the safety of medication-use systems in hospital emergency services. / Evaluación de la seguridad del sistema de utilización de los medicamentos en los servicios de urgencias hospitalarios.

INTRODUCTION: The aim of this study was to assess the implementation of safe medication practices in hospital emergency services, in order to understand the points of greatest risk as well as the safety challenges faced by these departments, and to plan collaboratively improvement initiatives. METHOD: Multicentric and descriptive study based on completion of the "Medication safety self-assessment of emergency services" from 5/16/2023 to 11/16/2023, at voluntarily participating emergency services. The survey contained 93 items grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements and for each individual item of evaluation, were assessed. RESULTS: A total of 72 emergency services completed the questionnaire. The mean score obtained for the overall questionnaire was 428.3 points (51.1% of the maximum score). Results showed a large variation among the scores of the participating services (range: 164-620.5). Four key elements had values below 50%, corresponding to competence and training of professionals in safety practices (38.4%); incorporation of pharmacists in emergency departments (42.1%), availability and accessibility of information about patients (43.1%), and patient education (48.1%). The highest values corresponded to labeling, packaging, and naming of medications (69.2%) and communication of prescriptions and other medication information (64%). No differences were found between emergency services in the key elements according to the dependency or size of the hospital, or the type of service, except for the item referring to the incorporation of pharmacists in the emergency service, where differences were observed between hospitals with less than 200 beds (28.9%) and those with more than 500 (52.2%). CONCLUSION: The application of the specific self-assessment questionnaire has made it possible to identify safety practices that are insufficiently implemented into emergency services in our country and to identify critical points for improvement for which planning collaborative initiatives to reduce medication errors in these departments should become a priority.

NRFit connectors in regional anaesthesia: avoiding medication errors.

The continuous development of medicine in most fields requires physicians to apply the latest methods and technology to ensure patients' safety. In the field of anesthesiology we are pioneers in the application of measures that guarantee the security of our patients, making possible the greatest reduction in mortality seen among all other specialties. This objective has been achieved thanks to the introduction of changes such as the one presented in this review article. The specific NRFit® connections for neuraxial and other regional anesthesia applications prevent wrong route medication errors to occur. These medication errors have been related to a high morbidity and mortality rate. This article reviews this new technology based in our own two-year experience at Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Madrid) as well as a literature review using PubMed, UpToDate and ClinicalKey.

Medication reconciliation in hospitalized hematological patient. / Conciliación de la medicación en el paciente hematológico ingresado.

OBJECTIVE: The main objective was to analyze unjustified discrepancies during the medication reconciliation process in patients admitted to the Hematology Service of our hospital and the pharmaceutical interventions. As a secondary objective, to detect possible points of the procedure to be perfected with a view to protocolizing the medication reconciliation process in hematological patients that adapts to the conditions of our center. METHODS: Cross-sectional observational pilot study carried out in a reference hospital in hematology for a population of 800,000 inhabitants. Adult inpatients admitted to the Hematology Service between August and October 2022 whose medication had been reconciled were included. The main variables were: number and type of unjustified discrepancy, proposed pharmaceutical intervention, and acceptance rate. RESULTS: 36 conciliation processes were analyzed, 34 admissions and 2 intrahospital transfer. 58.3% of the patients presented at least one unjustified discrepancy. 38 unjustified discrepancies were detected, with an acceptance of pharmaceutical interventions of 97.4%. The most common types of discrepancy were medication omission (56.8%) and drug interaction (24.3%). The most frequent pharmaceutical interventions were reintroducing medication (48.6%) and treatment discontinuation (16.2%). Polypharmacy and chemotherapy multiplied by 4 the probability of presenting drug interactions. CONCLUSIONS: The most common unjustified discrepancies in the medication reconciliation process in hospitalized hematology patients are: Medication omission and drug interactions. The reintroduction of medication and suspension of the prescription are the most frequent accepted pharmaceutical interventions. Polypharmacy is related to an increase in unjustified discrepancies. The factors that promote the appearance of interactions are admissions to receive chemotherapy treatment and polypharmacy. The main point of improvement detected is the need to create a circuit that allows conciliation to be carried out on discharge. Medication reconciliation contribute to improving patient safety by reducing medication errors.

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)

Servicio de Dispensación: un servicio esencial brindado desde la Farmacia Comunitaria que permite reforzar la Seguridad del Paciente. A propósito de un caso / Dispensing Service: An Essential Service Provided by Community Pharmacy to Enhance Patient Safety. A Case Study

Paciente de 38 años, diagnosticado de asma y ansiedad que utilizaba 2 medicamentos (salbutamol 100 mcg inhalador (2 pulv. cada 6 horas) y diazepam 5 mg (0-0-1)), acude a la Farmacia Comunitaria (FC) para retirar un tratamiento prescrito por el Médico de Atención Primaria (MAP) tras diagnóstico de un cuadro ansioso-depresivo. Desde el Servicio de Dispensación (SD) se detectó un Problema Relacionado con el Medicamento (PRM) de un potencial error en la prescripción, que podría tener asociado un Resultado Negativo asociado a la Medicación (RNM) ante uso concomitante de desvenlafaxina y mirtazapina, así como un PRM de Problema de Salud (PS) insuficientemente tratado ante una propuesta de suspensión de uso de diazepam, que podría derivar en un RNM de Necesidad de Tratamiento ante el riesgo de empeoramiento de episodios de ansiedad. Desde la FC, se elaboró un informe de derivación con recomendaciones que fueron aceptadas por el MAP. Se llevó a cabo un seguimiento del caso que permitió realizar un mejor control de los PS presentados por el paciente, así como la resolución de los PRM y RNM detectados, garantizando así un uso racional, seguro y eficaz del medicamento. (AU)

A 38-year-old patient diagnosed with asthma and anxiety, who takes two medications (salbutamol 100 mcg inhaler (2 puffs every 6 hours), and diazepam 5 mg (0-0-1), visited the Community Pharmacy to pick up a treatment prescribed by the Primary Care Physician (PCP) following a diagnosis of anxious-depressive symptoms. During the Dispensing Service, a potential Drug-Related Problem (DRP) of prescription error is detected, which could be related with a Negative Outcomes Releated to Medicines (NOM) due to the concurrent use of desvenlafaxine and mirtazapine. Additionally, a Health Problem (HP)-related DRP was detected, as the proposal to discontinue the use of diazepam could result in an Insufficiently Treated HP, potentially leading to a NOM of Treatment Necessity due to the risk of worsening anxiety episodes. From de Community Pharmacy, a report was prepared with recommendations that were accepted by the PCP. Subsequent case monitoring revealed an improved management of the patient’s health problems, as well as the resolution of the identified DRP and NOM. This ensured a rational, safe, and effective use of the medication. (AU)

Errores de medicación como elementos de la seguridad en el paciente: factores contributivos y estrategias de prevención por el profesional de enfermería / Medication errors as elements ofpatient safety: contributing factors and prevention strategies by the nursing professional

Introducción. Los errores de medicación (EM) pueden estar asociados con el ejercicio profesional en la prescripción, dispensación, distribución, administración de medicamentos, monitoreo y problemas de comunicación entre profesionales de la salud. La preparación y administración de medicamentos es un proceso de gran complejidad en el que los profesionales de enfermería desempeñan un papel fundamental como la última línea de defensa para evitar posibles daños relacionados con los fármacos en el paciente. El profesional de enfermería es el llamado a liderar el proceso de administración de medicamentos, asumiendo un rol esencial en el equipo de enfermería. Objetivo. Identificar los principales factores contributivos y estrategias de prevención, abordaje y gestión de servicios de enfermería frente a los errores de medicación desde la seguridad del paciente. Métodos: Se realizó una revisión de alcance tipo Scoping Review en Pubmed, EBSCO host, y Science Direct. Se emplearon descriptores identificados en Desc y Mesh artículos. Para seleccionar los artículos del presente artículo se utilizó la metodología prisma para revisiones. Resultados: Se encontraron 369 artículos en las bases abordadas de acuerdo con los criterios determinados,43 artículos se seleccionaron para la investigación. Conclusiones. Se identificaron los diferentes elementos que componen a la presencia de errores en la medicación; a su vez los factores generadores y/o contributivos para la presencia de estos errores durante la administración de medicamentos, a su vez se determinaron estrategias para prevención, abordaje y gestión de servicios de enfermería que disminuyan los potenciales riesgos identificados. Palabras clave: enfermería basada en la evidencia; seguridad del paciente; errores de medicación; enfermería; seguridad del paciente

Introduction. Medication errors (ME) can be associated with professional practice in prescribing, dispensing, distributing, administering medications, monitoring and communication problems between health professionals; The preparation and administration of medications is a highly complex process in which nursing professionals play a fundamental role as the last line of defense to prevent possible drug-related harm to the patient. The nursing professional is called upon to lead the medication administration process, assuming an essential role in the nursing team. Objective. To identify the main contributing factors and strategies for prevention, approach and management of nursing services in the face of medication errors from the perspective of patient safety. Methods: A Scoping Review type literature search was conducted in Pubmed, EBSCO host, and Science Direct. Descriptors identified in Desc and Mesh articles were used; the PRISMAmethodology for reviews was used to select the articles for this article.Results: 369 articles were found in the databases addressed according to the determined criteria; 43 articles were selected for the research.Conclusion. The different elements that make up the presence of medication errors were identified; in turn, the generating and/or contributing factors for the presence of these errors during the administration of medications, in turn, strategies for prevention, approach and management of nursing services that reduce the potential risks identified were determined. Key words:evidence-based nursing; patient safety; medication errors medication errors; nursing;patient safety

[Translated article] Trazam project: A mobile application for tracking preparations compounded in a pharmacy department.

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: i) evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, ii) assessing users satisfaction with the application, and iii) establishing a panel of quality indicators based on the data extracted from the App. METHODS: 1) Defining application requirements, identifying drugs to be included in the software and outlining different workflows. 2) 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. 3) 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 hospitalisation wards, day care units and two external sites. On average, 5403 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 min per day). The App regularly provides valuable management data for optimising 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.

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.

Prevalence of errors causing events allegedly attributable to vaccination/immunization: systematic review and meta-analysis / Prevalencia de errores causantes de acontecimientos supuestamente atribuibles a la vacunación/inmunización: revisión sistemática y metanálisis / Prevalência de erros que causaram eventos supostamente atribuíveis à vacinação/imunização: revisão sistemática e metanálise

ABSTRACT Objective: To identify the prevalence of errors that caused events supposedly attributable to vaccination or immunization. Method: Systematic literature review with meta-analysis carried out on the Medline, Cochrane Library, Cinahl, Web of Science, Lilacs, Scopus; Embase; Open Grey; Google Scholar; and Grey Lit databases; with studies that presented the prevalence of immunization errors that caused events or that provided data that allowed this indicator to be calculated. Results: We evaluated 11 articles published between 2010 and 2021, indicating a prevalence of 0.044 errors per 10,000 doses administered (n=762; CI95%: 0.026 - 0.075; I2 = 99%, p < 0.01). The prevalence was higher in children under 5 (0.334 / 10,000 doses; n=14). The predominant events were fever, local pain, edema and redness. Conclusion: A low prevalence of errors causing events was identified. However, events supposedly attributable to vaccination or immunization can contribute to vaccine hesitancy and, consequently, have an impact on vaccination coverage.

RESUMEN Objetivo: Identificar la prevalencia de errores que causaron eventos supuestamente atribuibles a la vacunación o inmunización. Método: Revisión sistemática de la literatura con metaanálisis realizada en las bases de datos Medline, Cochrane Library, Cinahl, Web of Science, Lilacs, Scopus; Embase; Open Grey; Google Scholar; y Grey Lit; con estudios que presentaran la prevalencia de errores de inmunización que causaron eventos o que aportaran datos que permitieran calcular este indicador. Resultados: Se evaluaron 11 artículos publicados entre 2010 y 2021, indicando una prevalencia de 0,044 errores por cada 10.000 dosis administradas (n=762; IC95%: 0,026 - 0,075; I2 = 99%, p < 0,01). La prevalencia fue mayor en niños menores de 5 años (0,334 / 10.000 dosis; n=14). Los eventos predominantes fueron fiebre, dolor local, edema y enrojecimiento. Conclusión: Se identificó una baja prevalencia de eventos causantes de errores. Sin embargo, los eventos supuestamente atribuibles a la vacunación o inmunización pueden contribuir a la indecisión sobre la vacunación y, en consecuencia, repercutir en la cobertura vacunal.

RESUMO Objetivo: Identificar a prevalência de erros que causaram eventos supostamente atribuíveis à vacinação ou imunização. Método: Revisão sistemática da literatura com metanálise realizada nas bases Medline, Cochrane Library, Cinahl, Web of Science, Lilacs, Scopus; Embase; Open Grey; Google Scholar; e Grey Lit; com estudos que apresentassem prevalência de erros de imunização que causaram eventos ou que disponibilizassem dados que permitissem o cálculo deste indicador. Resultados: Avaliou-se 11 artigos publicados entre 2010 e 2021, apontando prevalência de 0,044 erros por 10.000 doses administradas (n=762; IC95%: 0,026 - 0,075; I2= 99%, p < 0,01). A prevalência foi maior em crianças menores de 5 anos (0,334 / 10.000 doses; n=14). Quanto aos eventos, predominou-se: febre, dor local, edema, rubor. Conclusão: Identificou-se uma prevalência baixa de erros que causaram eventos. Entretanto, os eventos supostamente atribuíveis à vacinação ou imunização podem contribuir para a hesitação vacinal e, consequentemente, impactar nas coberturas vacinais.

Root cause analysis of safety incidents in antineoplastic use in children / Análisis de causa raíz de incidentes de seguridad en el uso de antineoplásicos en niños / Análise de causa raiz de incidentes de segurança na utilização de antineoplásicos em crianças

ABSTRACT Objectives: to identify and analyze the factors that contribute to safety incident occurrence in the processes of prescribing, preparing and dispensing antineoplastic medications in pediatric oncology patients. Methods: a quality improvement study focused on oncopediatric pharmaceutical care processes that identified and analyzed incidents between 2019-2020. A multidisciplinary group performed root cause analysis (RCA), identifying main contributing factors. Results: in 2019, seven incidents were recorded, 57% of which were prescription-related. In 2020, through active search, 34 incidents were identified, 65% relating to prescription, 29% to preparation and 6% to dispensing. The main contributing factors were interruptions, lack of electronic alert, work overload, training and staff shortages. Conclusions: the results showed that adequate recording and application of RCA to identified incidents can provide improvements in the quality of pediatric oncology care, mapping contributing factors and enabling managers to develop an effective action plan to mitigate risks associated with the process.

RESUMEN Objetivos: identificar y analizar los factores que contribuyen a la ocurrencia de incidentes de seguridad en los procesos de prescripción, preparación y dispensación de medicamentos antineoplásicos en pacientes pediátricos con cáncer. Métodos: estudio de mejora de la calidad centrado en los procesos de atención farmacéutica oncopediátrica que identificó y analizó incidencias entre 2019-2020. Un grupo multidisciplinario realizó un análisis de causa raíz (ACR), identificando los factores contribuyentes clave. Resultados: en 2019 se registraron siete incidentes, el 57% relacionados con la prescripción. En 2020, mediante búsqueda activa se identificaron 34 incidencias, el 65% relacionadas con la prescripción, el 29% con la preparación y el 6% con la dispensación. Los principales factores contribuyentes fueron las interrupciones, la falta de alerta electrónica, la sobrecarga de trabajo, la capacitación y la escasez de personal. Conclusiones: los resultados mostraron que el registro adecuado y la aplicación del ACR a los incidentes identificados pueden proporcionar mejora de la calidad de la atención del cáncer pediátrico mediante el mapeo de los factores contribuyentes y permitiendo a los administradores desarrollar un plan de acción eficaz para mitigar los riesgos asociados con el proceso.

RESUMO Objetivos: identificar e analisar os fatores contribuintes para ocorrência de incidentes de segurança nos processos de prescrição, preparo e dispensação de medicamentos antineoplásicos em pacientes oncopediátricos. Métodos: estudo de melhoria da qualidade focado nos processos de assistência farmacêutica oncopediátrica que identificou e analisou incidentes entre 2019-2020. Um grupo multidisciplinar realizou análise de causa raiz (ACR), identificando principais fatores contribuintes. Resultados: em 2019, registraram-se sete incidentes, sendo 57% relacionados à prescrição. Em 2020, através de busca ativa, identificaram-se 34 incidentes, sendo 65% relativos à prescrição, 29% ao preparo e 6% à dispensação. Os principais fatores contribuintes foram interrupções, ausência de alerta eletrônico, sobrecarga de trabalho, treinamento e déficit de funcionários. Conclusões: os resultados mostraram que registro adequado e aplicação da ACR aos incidentes identificados podem proporcionar melhoria na qualidade do cuidado oncopediátrico mapeando os fatores contribuintes e possibilitando aos gestores desenvolverem plano de ação efetivo para mitigar riscos associados ao processo.

Conciliación de la medicación al ingreso en paciente crónico pediátrico: estudio multicéntrico / Medication reconciliation at admission in paediatric patients with chronic illness: A multicentre study

Introducción: La conciliación de la medicación (CM) es una de las principales estrategias para disminuir los errores de medicación en las transiciones asistenciales. En España existen publicadas diferentes guías con recomendaciones para la implantación y el desarrollo de la CM orientadas a la población adulta, sin estar los pacientes pediátricos incluidos. En el año 2018 se llevó a cabo un estudio que permitió la posterior publicación de un documento con criterios de selección de pacientes pediátricos en los que priorizar la CM. Objetivos: Describir las características de los pacientes pediátricos con mayor probabilidad de sufrir errores de conciliación (EC), para confirmar si los resultados de un estudio previo son extrapolables. Metodología: Estudio prospectivo y multicéntrico con pacientes pediátricos ingresados. Se analizaron los EC detectados durante la realización de la CM al ingreso. La mejor historia farmacoterapéutica posible del paciente fue obtenida utilizando diferentes fuentes de información y confirmándose con una entrevista con el paciente/cuidador. Resultados: Se detectaron 1.043 discrepancias, determinándose como EC 544, afectando a 317 pacientes (43%). La omisión de algún medicamento fue el error más común (51%). La mayoría de los EC se asociaron con los medicamentos de los grupos A (31%), N (23%) y R (11%) de la clasificación ATC. La polimedicación y la enfermedad de base onco-hematológica fueron los factores de riesgo asociados a la presencia de EC con significación estadística. Conclusiones: Los hallazgos de este estudio permiten priorizar la CM en un grupo concreto de pacientes pediátricos, favoreciendo la eficiencia del proceso. Los pacientes onco-hematológicos y la polimedicación se confirman como los principales factores de riesgo para la aparición de EC en la población pediátrica.(AU)

Introduction: Medication reconciliation (MR) is one of the main strategies used to reduce medication errors in care transitions. In Spain, several guidelines have been published with recommendations for the implementation and development of MR processes aimed at the adult population, and not applicable to paediatric patients. In 2018, a study was carried out that allowed the subsequent publication of a document establishing criteria for the selection of paediatric patients in whom CM should be prioritised. Objectives: To describe the characteristics of the paediatric patients most likely to be subject to reconciliation errors (REs) to confirm whether the results of a previous study could be extrapolated. Methodology: Prospective, multicentre study in paediatric inpatients. We analysed the REs detected in the MR at the time of admission. We obtained the best possible medication history of the patient using different sources of information, subsequently confirmed through an interview with the patient/caregiver. Results: 1043 discrepancies were detected, of which 544 were categorised as REs, affecting 317 patients (43%). Omission of a drug was the most common error (51%). Most REs involved drugs in groups A (31%), N (23%) and R (11%) of the ATC classification. Polypharmacy and oncological/haematological disease were the risk factors that exhibited a statistically significant association with the occurrence of REs. Conclusions: The findings of this study allow the prioritisation of MR in a specific group of paediatric patients, contributing to improve the efficiency of the process. Oncological/haematological disease and polypharmacy were confirmed as the main risk factors for the occurrence of REs in the paediatric population.(AU)

Estudio multicéntrico de conciliación de la medicación en onco-hematología pediátrica / Multicentre study of medication reconciliation in paediatric onco-hematology

Objetivo determinar la prevalencia de errores de conciliación (EC) al ingreso hospitalario en la población pediátrica onco-hematológica para comprobar si ésta presenta una susceptibilidad similar a la de los adultos para ser afectados por estos EC y describir las características de los pacientes en los que se producen.Métodoestudio prospectivo y multicéntrico de 12 meses de duración, de conciliación de medicación al ingreso en la población pediátrica onco-hematológica para evaluar la incidencia de EC y describir las características de los pacientes en los que se producen.Resultadosse concilió la medicación de 157 pacientes. En 96 pacientes se detectó al menos una discrepancia de la medicación. De las discrepancias detectadas, el 52,1% fueron justificadas por la nueva situación clínica del paciente o por el médico responsable mientras que el 48,9% se consideraron EC. El tipo de EC más frecuente fue la «omisión de algún medicamento», seguido por «una dosis, frecuencia o vía de administración diferente». Se efectuaron un total de 77 intervenciones farmacéuticas, de las que se aceptaron el 94,2%. En el grupo de pacientes con un número igual o mayor a 4 fármacos en tratamiento domiciliario se observó un incremento de 2,1 veces la probabilidad de experimentar un EC.Conclusionespara evitar o reducir los errores en uno de los puntos críticos de seguridad como son las transiciones asistenciales, existen medidas, como la conciliación de la medicación. En el caso de los pacientes pediátricos crónicos complejos, como los pacientes onco-hematológicos, el número de fármacos como parte del tratamiento domiciliario es la variable que se ha asociado a la presencia de EC al ingreso hospitalario, siendo la omisión de algún medicamento la causa principal de estos errores. (AU)

Objective To determine the prevalence of reconciliation errors (RE) on admission to hospital in the paediatric onco-haematological population in order to check whether they are similarly susceptible to these RE as adults and to describe the characteristics of the patients who suffer them.MethodsA 12-month prospective, multicentre study of medication reconciliation on admission in the paediatric onco-haematological population to assess the incidence of RE and describe the characteristics of the patients in whom they occur.ResultsMedication reconciliation was performed in 157 patients. At least 1 medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were justified by the patient's new clinical situation or by the physician, while 48.9% were determined to be RE. The most frequent type of RE was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a RE.ConclusionsIn order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic paediatric patients, such as onco-haematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication RE on admission to hospital, with the omission of some medication being the main cause of these errors. (AU)

Análisis del grado de implantación de las prácticas de prevención de errores de medicación en los hospitales españoles (2022) / Analysis of the degree of implementation of medication error prevention practices in Spanish hospitals (2022)

Objetivo conocer el grado de implantación de las prácticas de prevención de errores de medicación en los hospitales españoles. Método estudio descriptivo multicéntrico del grado de implantación de las prácticas seguras recogidas en el «Cuestionario de autoevaluación de la seguridad del uso de los medicamentos en los hospitales. Versión II». Participaron aquellos hospitales españoles que cumplimentaron este cuestionario entre octubre de 2021 y septiembre de 2022. El cuestionario contiene 265 ítems de evaluación agrupados en 10 elementos clave. Se calculó la puntuación media y el porcentaje medio sobre el valor máximo posible para el cuestionario completo, los elementos clave y los ítems de evaluación. Los resultados se compararon con los del estudio realizado en 2011. Resultados participaron 131 hospitales de 15 comunidades autónomas. La puntuación media del cuestionario completo en los hospitales fue de 898,2 (57,4% del valor máximo posible). No se encontraron diferencias según la dependencia, el tamaño o la finalidad asistencial, ni en el cuestionario completo ni en los elementos clave. Presentaron los valores más bajos los elementos clave VIII, I y VI, sobre competencia y formación de los profesionales en prácticas seguras (45,1%), disponibilidad y accesibilidad de la información esencial sobre los pacientes (48%) y dispositivos para la administración de medicamentos (52,3%). Con respecto a 2011, se encontraron aumentos significativos tanto en el cuestionario completo como en los elementos clave, excepto en el V y VII, referentes a la estandarización, almacenamiento y distribución de medicamentos, y a los factores del entorno y recursos humanos. ...(AU)

Objective To assess the degree of implementation of medication error prevention practices in Spanish hospitals. Method Descriptive multicenter study of the degree of implementation of the safety practices included in the "Medication use-system safety self-assessment for hospitals. Version. II". Spanish hospitals that completed the questionnaire between October/2021 and September/2022 participated. The survey contains 265 items for evaluation grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements and for each individual item of evaluation were calculated. The results were compared with those of the previous 2011 study. Results A total of 131 hospitals from 15 autonomous regions participated in the study. The mean score of the overall questionnaire in all hospitals was 898.2 (57.4% of the maximum possible score). No differences were found according to dependency, size or type of hospital, either in the overall questionnaire or in the key elements. The lowest values were found for key elements 8, 1 and 6, on competence and training of health professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and devices for administering drugs (52.3%). With respect to 2011, significant increases were found both in the overall questionnaire and in the key elements, except 5 and 7, referring to standardization, storage and distribution of medications, and environmental factors and human resources. Several evaluation items on the safe management of high-risk drugs, medication reconciliation, incorporation of clinical pharmacists into the healthcare teams and implementation of technologies that allow full traceability throughout the medication system, showed low percentages. Conclusions.... (AU)

Atención farmacéutica en pacientes con inmunodeficiencia adquirida y/o tuberculosis en el área ambulatoria de un hospital pediátrico / Pharmacovigilance in patients with acquired immunodeficiency and/or tuberculosis in the outpatient area of a pediatric hospital

La Atención farmacéutica (AF) ayuda a los pacientes a alcanzar objetivos terapéuticos reduciendo los problemas relacionados al medicamento (PRM). Objetivos: analizar los PRM en la práctica de la AF a pacientes con inmunodeficiencia adquirida (IDA) y/o tuberculosis (TBC) y evaluar su impacto. Método: estudio, descriptivo, observacional, en el área ambulatoria de Farmacia. Se incluyeron pacientes con IDA y/o TBC con: inicio de tratamiento, polifarmacia, reinternaciones frecuentes, regular/mala adherencia, reacciones adversas a medicamentos (RAM) previas y/o comorbilidades. Se entrevistaron pacientes o cuidadores y se registraron PRM, errores, grados de adherencia y conocimiento farmacoterapéutico, retiro oportuno de medicamentos y parámetros clínicos. Se registró la intervención farmacéutica y entregó material educativo. Se repitieron las mediciones en una segunda entrevista. Resultados: Se estudiaron 54 pacientes (28 con IDA y 26 con TBC). Se realizaron 93 intervenciones (29.9% dirigidas al prescriptor, 27.8% a otros profesionales) y se detectaron 8 RAM y 53 errores (28 IDA y 25 TBC), el principal PRM fue la mala/regular adherencia con bajo porcentaje de conocimiento farmacoterapéutico completo. Después de la AF, en IDA el grado de adherencia tuvo una mejora estadísticamente significativa (p= 0.012), también fue significativa la mejora en el retiro oportuno de la medicación (28.6% a 71.4% p=0.005 IDA). Se obtuvieron resultados favorables de carga viral (CV) en 72% pacientes con IDA y aumento de peso en 92% pacientes con TBC, aunque no fueron estadísticamente significativos. Conclusiones: mediante AF se mejoró la adherencia y la comunicación en pacientes pediátricos con IDA y/o TBC (AU)

Pharmacovigilance (PV) helps patients achieve therapeutic goals by reducing drug-related problems (DRP). Objectives: to analyze DRPs in the practice of PV in patients with acquired immunodeficiency (AIDS) and/or tuberculosis (TB) and to evaluate its impact. Methods: A descriptive, observational study was conducted in the outpatient pharmacy area. Patients with AIDS and/or TB with: treatment initiation, polypharmacy, frequent readmissions, regular/poor adherence, previous adverse drug reactions (ADR) and/or comorbidities were included. Patients or caregivers were interviewed, and DRP, errors, adherence and pharmacotherapeutic knowledge, timely drug withdrawal, and clinical parameters were recorded. The pharmaceutical intervention was recorded and educational material was delivered. Measurements were repeated in a second interview. Results: We studied 54 patients (28 with AIDS and 26 with TB). Ninety-three interventions were performed (29.9% addressed to the drug prescriber, 27.8% to other professionals) and 8 ADRs and 53 errors were detected (28 AIDS and 25 TB). The main DRP was poor/regular adherence together with a low level of complete pharmacotherapeutic knowledge. After PV, in patients with AIDS the degree of adherence statistically significantly improved (p= 0.012). The improvement in timely medication withdrawal was also significant (28.6% vs. 71.4% p=0.005 AID). Favorable viral load results were obtained in 72% of patients with AIDS and weight gain in 92% of patients with TB, although they were not statistically significant. Conclusions: PV improved adherence and communication in pediatric patients with AIDS and/or TB (AU)

Nurseped: tecnología educativa para la seguridad en el manejo de antibióticos intravenosos en pediatría / Nurseped: educational technology for safety in the management of intravenous antibiotics in pediatrics / Nurseped: tecnologia educacional para a segurança no manejo de antibióticos endovenosos em pediatria

Objetivo: desarrollar y validar el contenido de un serious game sobre el manejo seguro de medicamentos intravenosos en pediatría. Método: estudio metodológico para el desarrollo y validación de contenido de una tecnología educativa. Los casos y desafíos del serious game se basaron en una revisión de la literatura y fueron validados por 11 enfermeros con formación y experiencia en el área. Se adoptaron índices de validez de contenido y concordancia para el análisis de concordancia y consistencia interna (mínimo de 0,8). Resultados: el contenido se basa en los principales antibióticos utilizados en el manejo clínico de infecciones en niños hospitalizados y en la seguridad del paciente. Se obtuvo una concordancia absoluta en 60 de los 61 ítems evaluados, y el mínimo obtenido fue de 0,82 en el índice de validación de contenido y 0,80 en concordancia. Los expertos sugirieron ajustes en la formulación de respuestas de un caso específico y se implementaron para mejorar la calidad del contenido de la tecnología. Conclusión: el contenido del serious game Nurseped fue validado por enfermeros expertos en salud infantil en cuanto a casos clínicos, enunciados de preguntas y respuestas de opción múltiple, además del feedback que presenta al usuario una respuesta basada en evidencia tras acertar o fallar en el desafío.

Objective: to develop and validate the content of a serious game on the safe management of intravenous medications in pediatrics. Method: methodological study for the development and content validation of an educational technology. The cases and challenges of the serious game were developed based on a literature review and validated by 11 nurses with training and experience in the area. Content validity and agreement indices were adopted to analyze agreement and internal consistency (minimum of 0.8). Results: the content is based on the main antibiotics used in the clinical management of infections in hospitalized children and patient safety. Absolute agreement was obtained in 60 of the 61 items evaluated, and the minimum obtained was 0.82 in the content validation index and 0.80 in agreement. Adjustments were suggested by experts in the response statement for a specific case and implemented to improve the quality of the technology content. Conclusion: the content of the serious game Nurseped was validated by nurse experts in child health regarding clinical cases, question statements and multiple-choice answers, in addition to feedback that presents the user with an evidence-based answer after getting the challenge right or wrong.

Objetivo: desenvolver e validar o conteúdo de um serious game sobre o manejo seguro de medicamentos endovenosos em pediatria. Método: estudo metodológico para o desenvolvimento e validação de conteúdo de uma tecnologia educacional. Os casos e desafios do serious game foram desenvolvidos com base em revisão da literatura e validados por 11 enfermeiros com formação e atuação na área. Adotou-se os índices de validade de conteúdo e concordância, para análise de concordância e consistência interna (mínimo de 0,8). Resultados: o conteúdo é baseado nos principais antibióticos utilizados no manejo clínico de infecções em crianças hospitalizadas e na segurança do paciente. Obteve-se concordância absoluta em 60 dos 61 itens avaliados, o mínimo obtido foi 0,82 no índice de validação de conteúdo e 0,80 na concordância. Ajustes foram sugeridos pelos experts no enunciado de respostas de um caso específico e implementados para o aprimoramento da qualidade do conteúdo da tecnologia. Conclusão: o conteúdo do serious game Nurseped foi validado por enfermeiros experts em saúde da criança quanto aos casos clínicos, aos enunciados das perguntas e às respostas de múltipla escolha, além do feedback que apresenta ao usuário uma resposta baseada em evidências após o acerto ou erro do desafio.

Medication reconciliation on admission in paediatric chronic patients: A multicentre study.

INTRODUCTION: Medication reconciliation (MC) is one of the main strategies to reduce medication errors in care transitions. In Spain, several guidelines have been published with recommendations for the implementation and development of MC aimed at the adult population, although paediatric patients are not included. In 2018, a study was carried out that led to the subsequent publication of a document with criteria for selecting paediatric patients in whom CM should be prioritised. OBJECTIVES: To describe the characteristics of paediatric patients most likely to suffer from errors of reconciliation (EC), to confirm whether the results of a previous study can be extrapolated. METHODOLOGY: Prospective, multicentre study of paediatric inpatients. We analysed the CE detected during the performance of the CM on admission. The best possible pharmacotherapeutic history of the patient was obtained using different sources of information and confirmed by an interview with the patient/caregiver. RESULTS: 1043 discrepancies were detected, 544 were identified as CD, affecting 317 patients (43%). Omission of a drug was the most common error (51%). The majority of CD were associated with drugs in groups A (31%), N (23%) and R (11%) of the ATC classification. Polymedication and onco-haematological based disease were the risk factors associated with the presence of CD with statistical significance. CONCLUSIONS: The findings of this study allow prioritisation of CM in a specific group of paediatric patients, favouring the efficiency of the process. Onco-haematological patients and polymedication are confirmed as the main risk factors for the appearance of CD in the paediatric population.

[Translated article] Analysis of the degree of implementation of medication error prevention practices in Spanish hospitals (2022).

OBJECTIVE: To assess the degree of implementation of medication error prevention practices in Spanish hospitals. METHOD: Descriptive multicenter study of the degree of implementation of the safety practices included in the "Medication use-system safety self-assessment for hospitals. Version. II". Spanish hospitals that completed the questionnaire between October, 2021 and September, 2022 participated. The survey contains 265 items for evaluation grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements, and for each individual item of evaluation were calculated. The results were compared with those of the previous 2011 study. RESULTS: A total of 131 hospitals from 15 autonomous regions participated in the study. The mean score of the overall questionnaire in all hospitals was 898.2 (57.4% of the maximum possible score). No differences were found according to dependency, size, or type of hospital, either in the overall questionnaire or in the key elements. The lowest values were found for key elements VIII, I and VI, on competence and training of health professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and devices for administering drugs (52.3%). With respect to 2011, significant increases were found both in the overall questionnaire and in the key elements, except V and VII, referring to standardization, storage, and distribution of medications, and environmental factors and human resources. Several evaluation items on the safe management of high-risk drugs, medication reconciliation, incorporation of clinical pharmacists into the healthcare teams, and implementation of technologies that allow full traceability throughout the medication system, showed low percentages. CONCLUSIONS: There has been appreciable progress in the degree of implementation of some medication error prevention practices in Spanish hospitals, but many proven efficacy practices recommended by the World Health Organization and safety organizations are still poorly implemented. The information obtained can be useful for prioritizing the practices to be addressed and as a new baseline for monitoring progress.