Root cause analysis of safety incidents in antineoplastic use in children.

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.

Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use-A Narrative Review.

The spread of antimicrobial resistance (AMR) is a global challenge. Close and continuous surveillance for quick detection of AMR can be difficult, especially in remote places. This narrative review focuses on the contributions of pharmacovigilance (PV) as an auxiliary tool for identifying and monitoring the ineffectiveness, resistance, and inappropriate use of antibiotics (ABs). The terms "drug ineffective", "therapeutic failure", "drug resistance", "pathogen resistance", and "multidrug resistance" were found in PV databases and dictionaries, denoting ineffectiveness. These terms cover a range of problems that should be better investigated because they are useful in warning about possible causes of AMR. "Medication errors", especially those related to dose and indication, and "Off-label use" are highlighted in the literature, suggesting inappropriate use of ABs. Hence, the included studies show that the terms of interest related to AMR and use are not only present but frequent in PV surveillance programs. This review illustrates the feasibility of using PV as a complementary tool for antimicrobial stewardship activities, especially in scenarios where other resources are scarce.

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.

A Rare Case of Transfusion Transmission of Hepatitis A Virus to Two Patients with Haematological Disease.

BACKGROUND: This paper describes the transmission of hepatitis A virus (HAV) to two blood recipients from a healthy donor that later presented to the blood bank with jaundice. METHODS: The RNA of HAV was detected by qualitative nested reverse transcription polymerase chain reaction (nested RT-PCR) and quantified by real-time RT-PCR. HAV RNA samples were genotyped by direct sequencing of PCR products. A sequence from a fragment of 168 bp from the VP1/2A HAV region was used to construct a phylogenetic tree. CASE REPORT: A 31-year-old male donor accepted for donation of a whole blood unit returned to the blood bank with clinical jaundice 20 days after donation. His serological and NAT tests were negative for HBV and HCV. Serological tests for HAV IgM and IgG were negative on donation sample but positive on follow-up sample, confirming donor's HAV acute infection. Both recipients of red blood cells (R1) and platelet concentrate (R2) from the same implicated donation were HAV IgM-negative and IgG-positive. Qualitative PCR was positive on samples from all three individuals and phylogenetic analysis of viruses proved HAV transmission to the two recipients of blood products. HAV viral load on donor follow-up sample and the platelet recipient was 1.3 and 1.5 × 10(3) IU/ml, respectively. The RBC recipient, also infected by HCV, was undergoing bone marrow transplantation and died from fulminant hepatitis, 26 days after the implicated HAV transfusion. CONCLUSION: The blood donor, a garbage collector, spontaneously returned to the blood bank when developing jaundice. This highlights the importance of donor education to immediately report to blood banks of any signs and symptoms related to infectious disease developed after blood donation. The fact that one immunocompromised patient with HCV infection died from fulminant hepatitis after receiving a HAV-contaminated platelet transfusion underpins the importance of a HAV vaccination program for these group of patients.

Fatores relacionados à utilização de flumazenil em pacientes hospitalizados / Factors related to use of flumazenil in hospitalized patients / Factores relacionados con el uso de flumazenil en pacientes hospitalizados

Interações medicamentosas (IM) exacerbam o risco de eventos adversos graves relacionados ao uso de benzodiazepínicos. Este estudo objetivou conhecer aspectos relacionados à utilização de flumazenil em pacientes hospitalizados. Através do método observacional, foram analisados prescrições e prontuários de 31 pacientes internados entre junho/2008 e junho/2010 quanto à indicação do flumazenil, aos fatores que podem ter contribuído para intoxicação por benzodiazepínicos e à frequência de IM potenciais (IMP). A frequência de indicação para reversão de sedação excessiva foi aproximadamente 1,3 prescrições por 1.000 pacientes. Foram identificadas IMP em 84% dessas prescrições. Para sete casos, não houve prescrição prévia de benzodiazepínicos. O exame permitiu a identificação dos eventos com necessidade do manejo da sedação excessiva relacionados à ocorrência de IMP entre benzodiazepínicos e outros medicamentos para um elevado percentual de pacientes. Observou-se que idade elevada, quadro clínico com muitas comorbidades e administração de medicamentos com interações bem definidas estiveram associados à hipersedação...

Drug interactions (DIs) heighten the risk of severe adverse events connected with use of benzodiazepines. This observational study aimed to ascertain aspects of use of flumazenil in hospital inpatients. The prescriptions and medicalrecords of 31 patients admitted between June 2008 and June 2010 were examined for indication of flumazenil, factors that could have contributed to benzodiazepine intoxication, and potential drug interaction (PDI) frequency. In 1.3 prescriptions per 1,000 patients the indication was for reversal of excessive sedation. PDIs were observed in 84% of these prescriptions. In 7 cases there was no prior prescription of benzodiazepines. The examination identified events requiring management of excessive sedation associated with occurrence of PDI between benzodiazepines and other drugs in a high percentage of patients. It was observed that more advanced age, clinical condition with many comorbidities, and administration of drugs with well-defined interactions were observed to associate with over-sedation...

Interacciones medicamentosas (IM) incrementan el riesgo de efectos adversos graves. Este estudio observacional investigó los aspectos relacionados con el uso de flumazenil en los pacientes hospitalizados. Se analizaron las prescripciones y prontuarios de 31 pacientes ingresados entre junio/2008 y junio/2010. La frecuencia de la indicación de reversión de la sedación excesiva fue de 1,3 prescripciones por 1.000 pacientes. Se identificaron IMP en 84% de estas prescripciones. En siete casos no hubo prescripción previa de benzodiazepínicos. Este estudio permitió la identificación de la sedación excesiva asociada con la aparición de IMP entre los benzodiazepínicos y otras drogas para un alto porcentaje de pacientes. Se ha observado que la edad avanzada, cuadro clínico con muchas comorbilidades y administración de fármacos con interacciones bien definidas se asociaron con excesiva sedación...

Incorporação e gasto com medicamentos de relevância financeira em hospital universitário de alta complexidade. / Incorporation and usage of financially relevant medicines in a highly complex federal university hospital.

O presente estudo analisou a incorporação e o gasto com medicamentos de relevância financeira, entre outubro de 2008 e setembro de 2009, em um hospital universitário federal de grande porte e alta complexidade situado no Estado do Rio de Janeiro. Foram consultadas fontes de consumo e custo da unidade para determinação dos gastos no período. Os medicamentos foram classificados pelo método ABC e, para aqueles de maior relevância financeira, buscaram-se informações sobre o processo de seleção, por meio dos documentos da Comissão de Farmácia e Terapêutica (CFT), para entendimento da dinâmica da incorporação. Foram gastos cerca de sete milhões de reais na aquisição de medicamentos, excetuando-se soluções parenterais de grande volume. O mesilato de imatinibe foi o medicamento de maior despesa anual, representando 23% do total gasto no período para tratamento de menos de 30 pacientes. Outros 56 itens de alto valor financeiro, somados ao imatinibe, representaram 15% do total de medicamentos e 85% do gasto anual, destacando-se os antineoplásicos e imunomoduladores. Foi observada grande escassez de dados sobre os critérios de seleção e monitoramento do uso de medicamentos de maior relevância nos gastos, apesar da instituição da CFT no hospital há mais de dez anos.

The present study analyzed incorporation and usage of financially relevant medicines in a large and highly complex university hospital in Rio de Janeiro, Brazil, between October 2008 and September 2009. All available sources of consumption and cost of the hospital were consulted in order to determine the expenses in this period. An ABC analysis was carried out to classify the medicines and the selection process of those with financial relevance was examined through Pharmacy and Therapeutic Committee (PTC) documents, to better understand the dynamics of incorporation of medicines. Approximately seven million reais were spent on medicines during the period, with the exception of large volume parenteral solutions. Imatinib mesylate accounted for the greatest annual expense, being responsible for 23% of usage in the period, used for chronic treatment of less than 30 patients. Added to imatinibe, the other 56 financially relevant items accounted for 15% of medicines and 85% of annual usage, with highlight to antineoplastics and immunomodulators. There was a notable lack of data regarding selection criteria and monitoring of use of financially relevant medicines, despite the presence of PTC in the hospital for more than a decade.