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. Objetivos prescripción Métodos 20192020. 20192020 2020. 2020 2019-2020 ACR, , (ACR) clave Resultados 201 57 3 65 29 6 interrupciones electrónica trabajo personal Conclusiones proceso 2019202 202 2019-202 (ACR 20 5 2 201920 2019-20 20192 2019-2 2019-

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. Objetivos prescrição oncopediátricos Métodos 20192020. 20192020 2019 2020. 2020 2019-2020 ACR, , (ACR) Resultados registraramse registraram se 57 ativa identificaramse identificaram 3 65 29 6 interrupções eletrônico trabalho funcionários Conclusões processo 2019202 201 202 2019-202 (ACR 5 2 201920 20 2019-20 20192 2019-2 2019-

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. Objectives prescribing patients Methods 20192020. 20192020 2019 2020. 2020 2019-2020 RCA, , (RCA) Results recorded 57 prescriptionrelated. prescriptionrelated prescription related. related prescription-related search 3 65 29 6 interruptions alert overload shortages Conclusions process 2019202 201 202 2019-202 (RCA 5 2 201920 20 2019-20 20192 2019-2 2019-

Resumo Este artigo tem como objetivo analisar características do fornecimento e fatores associados ao tratamento da artrite reumatoide no Brasil, com foco nos medicamentos biológicos modificadores do curso da doença (MMCDbio). Foi realizado um estudo retrospectivo com dados secundários do Sistema de Informação Ambulatorial do Sistema Único de Saúde. Foram incluídos pacientes com 16 anos ou mais, atendidos nos doze meses do ano de 2019. As análises foram feitas com fatores de exposição em relação aos desfechos: uso de MMCDbio e porte populacional. O estudo incluiu 155.679 pacientes, sendo 84,6% mulheres. Observou-se maior troca de MMCDbio e maior provisão de médicos reumatologistas nos municípios de maior porte (mais de 500 mil habitantes). Quase 40% dos pacientes utilizaram MMCDbio e estes apresentaram maior adesão ao tratamento (57,0% versus 64%, p=0,001). A dispensação de MMCDbio ocorreu para mais de um terço dos pacientes tratados para AR no Brasil e esteve associada ao maior percentual de disponibilidade de médicos reumatologistas e ao maior porte populacional dos municípios.

Abstract This study analyzes supply characteristics and factors associated with the treatment of rheumatoid arthritis in Brazil, with a focus on disease course-modifying biological drugs (bioDMARDs). A retrospective study was conducted with secondary data from the Outpatient Information System of the Unified Health System. Patients aged 16 years or older who were treated in 2019 were eligible. The analyses were performed with exposure factors in relation to the outcomes: bioDMARD use and population size. The study included 155,679 patients, 84.6% of whom were women. There was a greater exchange of bioDMARDs and a greater supply of rheumatologists in the larger municipalities (more than 500,000 inhabitants). Almost 40% of the patients used bioDMARDs, and they showed greater adherence to treatment (57.0% versus 64%, p=0.001). The dispensing of bioDMARDs occurred in more than one-third of the patients treated for rheumatoid arthritis (RA) in Brazil and was associated with a higher percentage of availability of rheumatologists and larger population size.

Abstract This study analyzes supply characteristics and factors associated with the treatment of rheumatoid arthritis in Brazil, with a focus on disease course-modifying biological drugs (bioDMARDs). A retrospective study was conducted with secondary data from the Outpatient Information System of the Unified Health System. Patients aged 16 years or older who were treated in 2019 were eligible. The analyses were performed with exposure factors in relation to the outcomes: bioDMARD use and population size. The study included 155,679 patients, 84.6% of whom were women. There was a greater exchange of bioDMARDs and a greater supply of rheumatologists in the larger municipalities (more than 500,000 inhabitants). Almost 40% of the patients used bioDMARDs, and they showed greater adherence to treatment (57.0% versus 64%, p=0.001). The dispensing of bioDMARDs occurred in more than one-third of the patients treated for rheumatoid arthritis (RA) in Brazil and was associated with a higher percentage of availability of rheumatologists and larger population size. coursemodifying course modifying bioDMARDs. . (bioDMARDs) 1 201 eligible outcomes size 155679 155 679 155,67 846 84 6 84.6 women 500000 500 000 500,00 inhabitants. inhabitants inhabitants) 40 57.0% 570 57 0 (57.0 64 64% p=0.001. p0001 p p=0.001 001 p=0.001) onethird one third RA (RA (bioDMARDs 20 15567 15 67 155,6 8 84. 50000 50 00 500,0 4 57.0 5 (57. p000 p=0.00 2 1556 155, 5000 500, 57. (57 p00 p=0.0 (5 p0 p=0. ( p=0 p=

Resumo Este artigo tem como objetivo analisar características do fornecimento e fatores associados ao tratamento da artrite reumatoide no Brasil, com foco nos medicamentos biológicos modificadores do curso da doença (MMCDbio). Foi realizado um estudo retrospectivo com dados secundários do Sistema de Informação Ambulatorial do Sistema Único de Saúde. Foram incluídos pacientes com 16 anos ou mais, atendidos nos doze meses do ano de 2019. As análises foram feitas com fatores de exposição em relação aos desfechos: uso de MMCDbio e porte populacional. O estudo incluiu 155.679 pacientes, sendo 84,6% mulheres. Observou-se maior troca de MMCDbio e maior provisão de médicos reumatologistas nos municípios de maior porte (mais de 500 mil habitantes). Quase 40% dos pacientes utilizaram MMCDbio e estes apresentaram maior adesão ao tratamento (57,0% versus 64%, p=0,001). A dispensação de MMCDbio ocorreu para mais de um terço dos pacientes tratados para AR no Brasil e esteve associada ao maior percentual de disponibilidade de médicos reumatologistas e ao maior porte populacional dos municípios. MMCDbio. . (MMCDbio) Saúde 1 2019 desfechos 155679 155 679 155.67 846 84 6 84,6 mulheres Observouse Observou se 50 habitantes. habitantes habitantes) 40 57,0% 570 57 0 (57,0 64 64% p=0,001. p0001 p p=0,001 001 p=0,001) (MMCDbio 201 15567 15 67 155.6 8 84, 5 4 57,0 (57, p000 p=0,00 00 20 1556 155. 57, (57 p00 p=0,0 2 (5 p0 p=0, ( p=0 p=

Abstract In pediatrics, drug therapy is commonly performed through adaptations of the dosage forms to adult use, increasing the risk of adverse drug reactions. In this context, studies assessing the severity and avoidability of the adverse reactions in children, especially those caused by antimicrobials, are still scarce. This work aimed to investigate suspected antimicrobial adverse reactions (ATM-ADRs) in pediatric patients admitted to a public hospital in northeastern Brazil, focusing on causality and avoidability analysis. A cohort study was carried out over a period of six months in a 64-bed pediatric unit. The incidence of suspected adverse reactions caused by antimicrobials was 14.65%. Most reactions were rated as probable (89.13%), with moderate severity (84.78%) and possibly avoidable (45.65%). The analysis indicated that the use of a larger number of medications (p<0.0001) and longer hospital stay (p=0.004) were related to the occurrence of ATM-ADR. Our findings demonstrated that almost half of the suspected reactions could be prevented and that the antimicrobial’s clinical management is relevant in this context. Besides, increasingly accurate adverse reaction classification instruments are essential. These results can support the development of therapeutic guidelines addressed to a safe and effective pharmacotherapy in the pediatric area.