Fatores associados ao comprometimento da segurança do paciente na unidade de terapia intensiva / Factors associated with the commitment of patient safety in the intensive care unit / Factores asociados al compromiso de la seguridad del paciente en la unidad de cuidados intensivos

Objetivo: conhecer os fatores associados ao comprometimento da segurança do paciente. Método: trata-se de um artigo de revisão integrativa da literatura a partir das bases de dados Scientific Electrônic Library Online, PubMed e Literatura Latino-americana e do Caribe em Ciências da Saúde, realizada entre abril e maio de 2022. Resultados: foi visto os principais fatores que corroboram para o comprometimento da segurança, sendo a utilização inadequada dos equipamentos, falta de rotina e ausência de protocolo no setor. Foi detectado a problemática da carga exacerbada de trabalho. Conflitos na equipe também foi tido como um preditor para existência de evento adverso. E por fim, o quesito da subnotificação dos erros. Conclusão: é visto a necessidade da gestão reverter esses problemas, para que a assim a porcentagem de erros seja diminuída.

Objective: to know the factors associated with compromised patient safety. Method: this is an integrative literature review article based on the Scientific Electronic Library Online, PubMed and Latin American and Caribbean Literature in Health Sciences databases, carried out between April and May 2022. Results: it was seen the main factors that corroborate for the compromise of safety, being the inadequate use of equipment, lack of routine and lack of protocol in the sector. The problem of exacerbated workload was detected. Conflicts in the team was also considered a predictor for the existence of an adverse event. And finally, the issue of underreporting of errors. Conclusion: the need for management to reverse these problems is seen, so that the percentage of errors is reduced.

Objetivos:conocer los factores asociados a la seguridad del paciente comprometida. Método: este es un artículo de revisión integradora de la literatura basado en las bases de datos Scientific Electronic Library Online, PubMed y Latin American and Caribbean Literature in Health Sciences, realizado entre abril y mayo de 2022. Resultados: se vieron los principales factores que corroboran para el compromiso de seguridad, siendo el uso inadecuado de equipos, falta de rutina y falta de protocolo en el sector. Se detectó el problema de la sobrecarga de trabajo. Los conflictos en el equipo también fueron considerados predictores de la existencia de un evento adverso. Y por último, el tema del subregistro de errores. Conclusión: se ve la necesidad de que la gestión revierta estos problemas, de modo que se reduzca el porcentaje de errores.

Headache as the most prevalent post-vaccination adverse event after Covid-19 vaccination / Dor de cabeça como evento adverso pós-vacinação mais prevalente após a vacinação contra Covid-19

BACKGROUND: In 2020, the first vaccines were approved, according to the WHO. However, speculations arose regarding their efficacy and post-vaccination adverse events (AEFV). OBJECTIVE: To evaluate the prevalence of headache as AEFI from the SARSCoV-2 vaccine in Piauí, Brazil. METHODS: This is a quantitative, observational, cross-sectional, and prevalence study. Data were provided by the Post-Vaccination Adverse Event Information System (SI-AEFV), from reported cases from January to September 2021. Data were analyzed, and the research was approved by the UFPI Research Ethics Committee. RESULTS: A total of 2,008 cases were analyzed. Headache was reported in 752 cases (27.99%) as an AEFV after vaccination against SARS-CoV-2. In most cases, patients were from Teresina (67.62%), of brown race/ethnicity (52.67%), female (79.00%), and the majority were not healthcare professionals (54.27%). The most common age of patients, with the original data, was 33 years. After data correction, the most common age was 28 years. The majority of these cases were not severe (96.44%), and the majority of cases were associated with the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine (43.18%).CONCLUSION: Thus, it is concluded from the partial analysis of the results that headache is the most common adverse event after vaccination against SARS-CoV-2. The profile of patients with the most notifications was brown women aged 30 to 40 years who received the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine. Regarding the severity of events, the vast majority were considered non-severe, and no deaths were mentioned, demonstrating the safety of immunobiologicals.

FUNDAMENTO: Em 2020, foram aprovadas as primeiras vacinas, segundo a OMS. No entanto, surgiram especulações quanto à sua eficácia e eventos adversos pós-vacinais (EAPV). OBJETIVO: Avaliar a prevalência de cefaleia como EAPV da vacina SARSCoV-2 no Piauí, Brasil. MÉTODOS: Trata-se de um estudo quantitativo, observacional, transversal e de prevalência. Os dados foram fornecidos pelo Sistema de Informação de Eventos Adversos Pós-Vacinação (SI-AEFV), dos casos notificados no período de janeiro a setembro de 2021. Os dados foram analisados ​​e a pesquisa foi aprovada pelo Comitê de Ética em Pesquisa da UFPI. RESULTADOS: Foram analisados ​​2.008 casos. Cefaleia foi relatada em 752 casos (27,99%) como EAPV após vacinação contra SARS-CoV-2. Na maioria dos casos, os pacientes eram procedentes de Teresina (67,62%), de raça/etnia parda (52,67%), do sexo feminino (79,00%) e a maioria não era profissional de saúde (54,27%). A idade mais comum dos pacientes, com os dados originais, era de 33 anos. Após correção dos dados, a idade mais comum foi 28 anos. A maioria desses casos não foi grave (96,44%), e a maioria dos casos esteve associada à primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca (43,18%).CONCLUSÃO: Assim, conclui-se a partir da análise parcial dos resultados de que cefaleia é o evento adverso mais comum após vacinação contra SARS-CoV-2. O perfil dos pacientes com mais notificações foi de mulheres pardas com idade entre 30 e 40 anos que receberam a primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca. Quanto à gravidade dos eventos, a grande maioria foi considerada não grave e não foram mencionados óbitos, demonstrando a segurança dos imunobiológicos.

Myelotoxicity and kidney dysfunction related to the use of trimethoprim-sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia: a case report of severe adverse events with a common drug

ABSTRACT Trimethoprim-sulfamethoxazole (TMP-SMX) is the primary therapeutic option for Pneumocystis jirovecii pneumonia (PCP). Gastrointestinal symptoms and cutaneous rash are common side effects, with hyperkalemia being uncommon in patients without kidney dysfunction, and myelotoxicity being even rarer. We present the case of a male patient with hypertension and a recent diagnosis of non-Hodgkin lymphoma, undergoing rituximab treatment for two months. He was admitted to the intensive care unit due to dyspnea, tachypnea, and pleuritic pain, requiring mechanical ventilation. Chest computed tomography showed bilateral and multilobed ground-glass opacities, compromising more than 80% of the lung parenchyma. Pulmonary tuberculosis and COVID-19 were ruled out. An angiotomography and Doppler ultrasound revealed an extensive pulmonary thrombus and deep venous thrombosis. Empiric treatment with TMP-SMX for PCP was initiated, but within four days, the patient experienced metabolic acidosis and severe hyperkalemia, necessitating hemodialysis. He also presented with progressive pancytopenia and critical levels of leukopenia and thrombocytopenia. The hypothesis of TMP-SMX-induced myelotoxicity was suspected. Considering the unavailability of an alternative treatment, it was opted to continue TMP-SMX and initiate a granulocyte-colony-stimulating factor. However, the patient maintained medullary deterioration, becoming refractory to the transfusion of blood derivates. On the 17th day of treatment, a clinical decision was made to suspend TMP-SMX, leading to improvements within 48 hours in marrow and kidney functions, metabolic acidosis, and hyperkalemia. Despite all efforts, the patient died after 35 days of hospitalization due to hospital-acquired infections. This case highlights the importance of clinicians recognizing potential myelotoxicity with TMP-SMX and promptly discontinuing the drug if necessary.

Safety Evaluation of Tianzhi Granules in Treating Mild-to-moderate Vascular Dementia / 中国实验方剂学杂志

ObjectiveTo systematically evaluate the safety of Tianzhi granules used in the treatment of mild-to-moderate vascular dementia. MethodA randomized， double-blind， double-simulated， positive drug/placebo parallel controlled multi-center phase Ⅳ clinical trial and an open multi-center phase Ⅳ clinical trial of Tianzhi granules in the treatment of mild-to-moderate vascular dementia were conducted. Safety data of 1 492 patients were included and analyzed according to inclusion and exclusion criteria. The main evaluation measures were the incidence rate of adverse events/adverse reactions， laboratory indicators， vital signs， and electrocardiogram （ECG） results. ResultA total of six adverse events possibly related to the test drug occurred in 520 patients of the double-blind trial， and the symptoms were all mild and recovered. The incidence of adverse events was not statistically different among Tianzhi granules， donepezil， and placebo groups. Nine adverse events possibly related to the test drug were observed in 972 patients of the open trial， and the symptoms were mild and recovered. Laboratory tests （blood routine， urine routine， liver function， kidney function， and coagulation） and vital signs were compared before treatment （baseline） and after treatment of 12 and 24 weeks， respectively. There was no statistical significance in the main indicators before and after treatment. In the double-blinded trial， there was no significant difference in safety indicators between different groups before and after treatment. The most frequent adverse reaction was gastrointestinal discomfort， with an incidence rate of 6.64‰. ConclusionAdverse reactions occasionally occur in patients using Tianzhi granules， and it is safe to use Tianzhi granules to treat mild-to-moderate vascular dementia clinically.

Sistemas de notificación de eventos adversos como estrategia para la cultura de calidad y seguridad del paciente / Adverse event reporting systems as a strategy for a culture of quality and patient safety

Introducción: el objetivo de los Sistemas de Notificación de Eventos Adversos, Eventos Centinela y Cuasifallas, es conocer la frecuencia con la que se presentan y generar las estrategias para su disminución y la no repetición de dichos eventos. Se debe informar al personal de salud involucrado en los procesos de atención, principalmente a quienes tienen contacto directo con los pacientes. Desarrollo: se realizó una revisión bibliográfica conceptual y de investigación sobre los sistemas de notificación de eventos adversos. La búsqueda y selección de artículos publicados de 2016 a 2021, fue en la base de datos PubMed y el índice de revistas de acceso abierto Medigraphic, mediante los siguientes criterios de búsqueda en español e inglés: sistemas de notificación, evento adverso, evento centinela, sistema VENCER, Instituto Mexicano del Seguro Social, Secretaría de Salud; así como el uso del operador booleano AND: Notificatión AND adverse event, notification system AND sentinel event, adverse event AND quality plan. Se obtuvo un aproximado de 194 resultados, de los cuales se seleccionaron los artículos que se apegaban al objetivo de esta revisión. Conclusiones: con la presente revisión bibliográfica se muestra que la notificación de los eventos adversos por parte del personal de la salud involucrados en los procesos de atención, adquiere especial relevancia cuando ésta es proporcional a la adquisición de luna cultura de calidad y seguridad en la atención de los pacientes... (AU)

Abstract Introduction: The objective of the Notification Systems for Adverse Events, Sentinel Events and Near Failures is to know the frequency with which they occur and to generate strategies for their reduction and non-repetition of said events. Health personnel involved in the care processes should be informed, mainly those who have direct contact with patients. Development: A conceptual and research literature review on adverse event reporting systems was carried out. The search and selection of articles published from 2016 to 2021 was in the PubMed database and the Medigraphic open access journal index, using the following search criteria in Spanish and English: notification systems, adverse event, sentinel event, VENCER system, Mexican Institute of Social Security, Ministry of Health, as well as the use of the boolean operator AND: Notification AND adverse event, notification system AND sentinel event, adverse event AND quality plan. An approximate of 194 results were obtained, from which the articles that met the objective of this review were selected. Conclusions: This bibliographic review shows that the notification of adverse events by health personnel involved in care processes acquires special relevance when it is proportional to the acquisition of a culture of quality and safety in care. from the patients.

Neurotoxidad inducida por ifosfamida / Ifosfamide-induced neurotoxicity

Introducción: La ifosfamida es un agente alquilante utilizado para el tratamiento de enfermedades oncohematológicas. Entre sus eventos adversos agudos se encuentra la neurotoxicidad. Esta puede presentarse desde el inicio de la infusión hasta tres días después. El tratamiento consiste en suspender la administración y asegurar una adecuada hidratación. Objetivo: Describir eventos neurológicos asociados al uso de ifosfamida en pacientes pediátricos con enfermedades oncohematológicas. Materiales y métodos: Estudio observacional, descriptivo, retrospectivo y transversal. Los datos se obtuvieron de historias clínicas de pacientes internados en el Hospital Garrahan que infundieron ifosfamida y desarrollaron síntomas neurológicos. Se analizaron edad, diagnóstico de base, dosis de ifosfamida, síntomas neurológicos y su relación con la infusión, tratamiento instaurado, exámenes complementarios y posibles factores de riesgo asociados. Resultados: Se registraron un total de catorce eventos neurológicos en doce pacientes, sin diferencia de sexo, con una mediana de edad de 9,5 años. La enfermedad de base más prevalente fue osteosarcoma. Las convulsiones fueron el síntoma más frecuente (50%), seguido de somnolencia y paresias. La combinación de ifosfamida y etopósido con/sin carboplatino se asoció en un 36% cada uno. El 64% desarrolló neurotoxicidad dentro de las primeras cuatro horas. Ningún paciente presentó alteraciones en los exámenes complementarios. Todos presentaron recuperación ad integrum. Conclusión: Este estudio brinda información acerca del tiempo de aparición de esta complicación, lo cual facilitará su detección precoz y tratamiento oportuno (AU)

Introduction: Ifosfamide is an alkylating agent used for the treatment of cancer. Among its acute adverse events is neurotoxicity. This can occur from the beginning of the infusion up to three days afterwards. Treatment consists of discontinuing administration and ensuring adequate hydration. Objective: To describe neurological events associated with the use of ifosfamide in children with cancer. Materials and methods: Observational, descriptive, retrospective, and cross-sectional study. Data were obtained from clinical records of patients admitted to the Garrahan Hospital who received ifosfamide infusion and developed neurological symptoms. Age, baseline diagnosis, ifosfamide dose, neurological symptoms and their relationship with the infusion, treatment, complementary tests, and possible associated risk factors were analyzed. Results: A total of fourteen neurological events were recorded in twelve patients, without difference in sex and with a median age of 9.5 years. The most prevalent underlying disease was osteosarcoma. Seizures were the most frequent symptom (50%), followed by drowsiness and paresis. The combination of ifosfamide and etoposide with/without carboplatin was associated in 36% each. Sixty-four percent developed neurotoxicity within the first four hours. None of the patients presented with abnormalities in the complementary examinations. All recovered ad integrum. Conclusion: This study provides information about the time of onset of this complication, which will facilitate its early detection and timely treatment (AU)

Adverse Events Following Immunization- The Known Unknowns and Black Box

Although vaccines are one of the most rigorously tested biological products, the safety concerns persist globally. The vaccine safety concerns linked to measles, pentavalent and human papillomavirus (HPV) vaccines have affected the vaccine coverage significantly in past. While surveillance of adverse events following immunization (AEFI) is part of the national immunization program mandate, it suffers from challenges and biases related to reporting, completeness, and quality. Some conditions of concern, termed as adverse events of special interest (AESI) following vaccination, mandated specialised studies to prove/disprove the association. The AEFIs/AESIs are usually caused by one of the four pathophysiologic mechanisms, but for several AEFIs/AESIs, the exact pathophysiology remains elusive. For the causality assessment of AEFIs, a systematic process with checklists and algorithm are followed to classify into one of the four causal association categories. While the causal association primarily banks on epidemiological observations for several AEFIs, the emerging evidences indicate roles of underlying genetic, gender, age and other pro-inflammatory risk factors for AEFIs and AESIs. The emerging evidences suggest role of antigenic mimicry, autoantibody(ies) and underlying genetic susceptibility for the AEFIs/AESIs. The uncertainty about the frequency, profile, interval, and severity of AEFIs/AESIs and variations across the population, ambiguity about the exact pathophysiology mechanism, absence of definite markers, suggest a possible black box effect of the vaccines. Unless these unanswered questions concerning the AEFIs/AESIs are addressed appropriately and communicated to the stakeholders (professionals, care providers, beneficiaries, general public and media), the anti-vaccine movement shall keep challenging the vaccine and vaccination program.

Autoimmune encephalitis related to nivolumab followed by tumor regression / Encefalitis autoinmune relacionada con nivolumab se guida de regresión tumoral

Abstract Immune checkpoints inhibitors have shown a re markable improvement in overall survival of stage IV renal cell carcinoma patients. Nevertheless, there is a wide range of immune-related adverse events (IRAE) that arise from these revolutionary treatments. Autoim mune encephalitis is a rare but severe central nervous system IRAE in these cancer patients. The severities of these IRAEs preclude patients from continuing im munotherapy treatment. Few cases of autoimmune encephalitis with immunotherapy have been described in the literature and optimal clinical management of these events as well as patient's immune-mediated response after treatment suspension is still unclear. Here, we report a case of a 67 years-old woman with stage IV renal cell carcinoma under treatment with nivolumab who developed autoimmune encephalitis. After high doses of corticosteroids patient's condition improved significantly with full recovery after 5 days of treatment. Even though nivolumab was not reinstalled, a persistent response of her oncologic disease was evi denced. We expect that this case can contribute to the existing literature of both subjects, the management of autoimmune encephalitis as grade IV immune related adverse event and the responses of immune checkpoint inhibitors after IRAE.

Resumen Los inhibidores de puntos de control inmunológico han mostrado una importante mejoría en la supervi vencia global de los pacientes con carcinoma de riñón estadio IV. Sin embargo, existe una amplia variedad de efectos adversos inmunomediados que surgen a partir de estos tratamientos revolucionarios. La encefalitis au toinmune es un infrecuente pero grave efecto adverso inmunomediado del sistema nervioso central en estos pacientes. La gravedad de este cuadro impide que los pa cientes continúen con el tratamiento de inmunoterapia. Se han descrito pocos casos de encefalitis autoinmune con inmunoterapia en la literatura y aún no está claro el manejo clínico óptimo de estos eventos, ni cómo continua la respuesta inmunomediada después de la suspensión del tratamiento. Presentamos el caso de una mujer de 67 años con carcinoma de células renales estadio IV que desarrolló encefalitis autoinmune durante el tratamiento con nivolumab. La paciente mejoró significativamente luego del inicio del tratamiento con altas dosis de cor ticoides, con una recuperación completa después de 5 días del mismo. Si bien el nivolumab no se reinició, se evidenció una respuesta persistente de su enfermedad oncológica. Esperamos que este caso pueda contribuir a la literatura existente de ambos temas, el manejo de la encefalitis autoinmune como efecto adverso inmunome diado grado IV y las respuestas que se obtienen con la inmunoterapia luego de estos efectos adversos.

Prevalência de reações adversas após vacinação contradengue em população jovem, no Paraná / Prevalence of adverse reactions after dengue vaccinein a young population, in Paraná

Objetivo: o presente estudo tem por objetivo demonstrar a prevalência de eventos adversos com uma vacina para dengue e sua correlação com características sociodemográficas e clínicas. Material e Método: trata-se de um estudo de coorte, foi aplicado questionário aos participantes e realizado contato telefônico após as doses da vacina. Foram também utilizados os dados do prontuário eletrônico do HU de Londrina, do Gerenciador de Ambiente Laboratorial do Paraná, do Sistema de Informação da Secretaria Municipal de Saúde e do aplicativo de Controle de Vacinação da Dengue do Paraná. As associações entre as variáveis e a presença de reação vacinal foram realizadas por meio do teste do qui-quadrado ou Exato de Fisher, após foi aplicada regressão logística binária. Resultados: dos 1.815 participantes, 6,5% tiveram alguma reação (sistêmica ou local) após a vacina. As reações mais prevalentes foram: cefaleia (59,6%), seguida de mal-estar (32,1%), febre (26,6%), mialgia (22%) e dor local (14,6%), sendo que a dor local foi a única reação que esteve presente nas três doses. Ocorreu maior chance de reação na primeira dose do que nas doses subsequentes (p<0,0001). Ser do sexo feminino [OR 1,701 (1,144-2,5416), p<0,009] aumentou a chance de reação vacinal; entretanto, ter doença de base [OR 0,001 (0,000-0,002), p=0,000] foi um fator protetor. Conclusão: o estudo demonstrou baixa reação adversa na população vacinada com a vacina da dengue.

Objective: the present study's purpose is to demonstrate the prevalence of dengue vaccine adverse events and its correlation with sociodemographic and clinical characteristics. Material and Methodology: as a cohort study, a questionnaire and phone interviews were applied to the young adults, and data was collected from a database of local services, the Laboratory Environment Manager Abstract of Paraná, and the Dengue Vaccination Control Application. The relation between variables and the presence of vaccine reaction was made via the chi-squared and Fisher exact tests, afterwards, the binary logistic regression method was applied. Results: from 1,815 participants, 6.5% have had some reaction, systemic or local, after receiving the vaccine dose. The most recurrent reactions identified were headaches (59.6%), followed by malaise (32.1%), fever (26.6%), myalgia (22%), local pain (14.6%), considering the last one the only reaction present in three vaccine doses. The first vaccine dose has had a greater chance of reaction comparing to the subsequent doses (p<0.0001). Being female [OR 1.701 (1.144-2.5416), p<0.009] increased the chance of vaccine reaction; however, to have an underlying disease [OR 0.001(0.000-0.002), p=0.000] was a protective factor. Conclusion: the study demonstrated low adverse reactions in the population vaccinated with the dengue vaccine.

Sufficient versus deficient rims during percutaneous closure of ostium secundum type atrial septal defect: A systematic review and meta-analysis

Background: The aim of this meta-analysis was to compare the efficacy and adverse events of percutaneous occlusion among patients with sufficient and deficient rims. Methods: A systematic review of all articles published in the Pubmed, MEDLINE and Google Scholar databases was performed. Odds ratio (OR) and 95% CI were used as a measure of effect of the combination of studies. I2 with 95% CI was estimated to assess study heterogeneity. For the meta-analysis, a random effects model was used. Results: The systematic search identified ten studies which included 4355 patients; 2661 of those had sufficient rim and the remaining 1694 patients showed some rim deficiency. Implant failure rate was 4.13% CI 95% 3.53e4.72%. Compared to frequency of failures in the group with a deficient rim (5.43% CI 95% 4.35e6.50%), implant failure in patients with a sufficient rim was significantly lower (3.30% CI 95% 2.62e3.97%), OR 2.27 CI 1.34e3.83 (p 0.002). The combined adverse events were 5.19% CI 95% 4.22e6.35% vs 2.7% CI 95% 2.08e3.31% in the deficient vs sufficient rim groups respectively (OR 2.21 CI 0.93e5.29; p 0.07). Implant failures and adverse events were more frequent in patients with posterior inferior rim deficiency. Conclusion: Patients presenting a posteroinferior rim deficiency are associated to both, an increased incidence of closure failure and a combined adverse events occurrence. More studies on posterior rim deficiency are necessary to ensure the feasibility and safety of the percutaneous approach.

Serious adverse event following immunization and thromboembolic events associated with COVID19 vaccination: An analysis of nationwide causality assessment from India

Background: Vaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following Immunization (AEFIs) reported for COVID-19 vaccines from India. Methods: Secondary data analysis of the causality assessment reports for the 1112 serious AEFIs published by the Ministry of Health & Family Welfare, Government of India, was conducted. For the current analysis, all the reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal association and the thromboembolic events. Results: The majority of the serious AEFIs assessed were either coincidental (578, 52%) or vaccine product related (218, 19.6%). All the serious AEFIs were reported among the Covishield (992, 89.2%) and COVAXIN (120, 10.8%) vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted analysis, females, the younger age group and non-fatal AEFIs showed a statistically significant consistent causal association with COVID-19 vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant association with higher age and case fatality rate. Conclusion: Deaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the COVID-19 vaccines than the recovered hospitalizations in India. No consistent causal association was found between the thromboembolic events and the type of COVID-19 vaccine administered in India

Guía práctica para el uso de clozapina en niños/as y adolescentes / Practical guidelines for the use of clozapine in children and adolescents

El uso de clozapina (CZP) en niños/as y adolescentes ha estado históricamente limitado, debido a los efectos adversos y riesgos médicos asociados al fármaco, a pesar de ser una herramienta farmacológica de gran efectividad en la psiquiatría general. A continuación, se presenta una guía clínica con los siguientes objetivos: 1) identificar los criterios de indicación de CZP en niños, niñas y adolescentes (NNA) según la evidencia disponible; 2) entregar algunas directrices a los clínicos y profesionales de salud respecto a la prescripción de CZP y precauciones a tener en consideración en esta población y; 3) entregar algunos datos comparativos del uso de CZP entre población infantojuvenil y población adulta. Todo lo anterior tiene como finalidad poder entregar la información necesaria para que los clínicos no limiten el uso de este fármaco y puedan prescribirlo de acuerdo con la evidencia científica disponible.

The use of clozapine (CZP) in children and adolescents has historically been limited due to the adverse effects and medical risks commonly associated with the drug, despite being a highly effective pharmacological tool in general psychiatry. Below we developed a clinical guideline with the following objectives: 1) identify the indication criteria for CZP in children and adolescents (NNA) according to the available evidence; 2) provide some guidelines to clinicians and health professionals regarding the prescription of CZP and precautions to be taken into account in this population and; 3) provide some comparative data on the use of CZP between the pediatric and adult population. The purpose of the guideline is to provide the necessary information so that clinicians do not limit the use of CLZ when needed and can prescribe it safely and according to the available scientific evidence.

Avaliação de prescrições médicas de medicamentos em uma emergência hospitalar / Evaluation of drug prescriptions in a hospital emergency department / Evaluación de la prescripción de medicamentos en un servicio de urgencias hospitalario

RESUMO Objetivo: avaliar a adesão das prescrições médicas de medicamentos às recomendações para segurança do paciente por meio do checklist - Lista de Verificação de Segurança na Prescrição de Medicamentos. Método: trata-se de um estudo observacional, transversal, realizado entre maio a junho de 2022, com 341 prescrições médicas de medicamentos, numa emergência hospitalar no interior da Bahia - Brasil, cujos dados foram analisados através de análise descritiva. Resultados: 80% a 89% das prescrições tiveram adesão às recomendações de segurança; o item de maior adesão foi identificação da data da prescrição, menor adesão foi possuir medicamentos com nomes semelhantes identificados com caixa alta ou negrito. Cerca de 18,63% (n=514) dos medicamentos prescritos fazem parte da lista de medicamentos potencialmente perigosos de uso hospitalar. Conclusão: a avaliação das prescrições médicas de medicamentos evidenciou barreiras existentes na prática clínica, o que possibilita a elaboração de mecanismos mais efetivos para promoção da segurança do paciente.

ABSTRACT Objective: To evaluate the adherence of medical prescriptions to patient safety recommendations using the Medication Prescription Safety Checklist. Method: This is an observational, cross-sectional study carried out between May and June 2022, with 341 medical prescriptions for medicines in a hospital emergency room in the interior of Bahia - Brazil, whose data were analyzed through descriptive analysis. Results: 80% to 89% of the prescriptions adhered to the safety recommendations; the item with the highest adherence was identification of the date of the prescription, and the lowest adherence was having drugs with similar names identified in upper case or bold. Around 18.63% (n=514) of the drugs prescribed are on the list of potentially dangerous drugs for hospital use. Conclusion: The evaluation of medical prescriptions for medicines highlighted existing barriers in clinical practice, which makes it possible to develop more effective mechanisms to promote patient safety.

RESUMEN Objetivo: Evaluar la adhesión de las prescripciones médicas a las recomendaciones de seguridad del paciente utilizando la checklist - Lista de verificación de la Seguridad de la Prescripción de Medicamentos. Método: Se trata de un estudio observacional, transversal, realizado entre mayo y junio de 2022, con 341 prescripciones médicas de medicamentos, en la sala de urgencias de un hospital del interior de Bahia - Brasil, cuyos datos fueron analizados mediante análisis descriptivo. Resultados: Entre el 80% y el 89% de las prescripciones cumplieron las recomendaciones de seguridad; el punto con mayor cumplimiento fue la identificación de la fecha de la prescripción, y el de menor cumplimiento, que los medicamentos con nombres similares se identificaran en mayúsculas o en negrita. Alrededor del 18,63% (n=514) de los medicamentos prescriptos figuran en la lista de medicamentos potencialmente peligrosos de uso hospitalario. Conclusiones: La evaluación de las prescripciones médicas de medicamentos puso de manifiesto los obstáculos existentes en la práctica clínica, lo que permite desarrollar mecanismos más eficaces para promover la seguridad de los pacientes.

A cultura de segurança do paciente na perspectiva da equipe de enfermagem / Patient safety culture from the nursing team's perspective / La cultura de seguridad del paciente desde la perspectiva del equipo de enfermería

RESUMO Objetivo: identificar o conhecimento da equipe de enfermagem sobre a segurança do paciente e a ocorrência de eventos adversos em Pronto Atendimento Médico. Método: estudo transversal, quantitativo, desenvolvido em hospital de ensino da região Centro-Oeste do Brasil. Foi realizado com profissionais de enfermagem por meio de um questionário online contendo questões relacionadas à segurança do paciente, aplicado em setembro de 2021. A análise dos dados foi descritiva. Resultado: Noventa profissionais participaram do estudo, sendo 28(31,1%) enfermeiros e 62(68,9%) técnicos de enfermagem. Na avaliação dos itens do questionário, o melhor índice de acerto foi sobre higienização das mãos 84(93,3%), o pior item avaliado foi protocolo de identificação do paciente 45(50%). A lesão por pressão foi apontada como o evento adverso mais frequente 28(33%). Conclusão: os resultados evidenciam que a educação permanente é fundamental para os profissionais aplicarem as metas internacionais de segurança do paciente na prática.

ABSTRACT Objective: to identify the nursing staff knowledge about patient safety and the occurrence of adverse events in Emergency Medical Care. Method: cross-sectional, quantitative study, developed in a teaching hospital in the Midwest region of Brazil. It was conducted with nursing professionals through an online questionnaire containing questions related to patient safety, applied in September 2021. The data analysis was descriptive. Results: Ninety professionals participated in the study, 28(31.1%) being nurses and 62(68.9%) nursing technicians. In the evaluation of the questionnaire items, the best score was about hand hygiene 84(93.3%), the worst evaluated item was patient identification protocol 45(50%). Pressure ulcers were indicated as the most frequent adverse event 28(33%). Conclusion: the results indicate that continuing education is essential for professionals to apply the international patient safety goals in practice.

RESUMEN Objetivo: identificar el conocimiento del equipo de enfermería sobre la seguridad del paciente y la ocurrencia de eventos adversos en la Atención Médica de Urgencia. Método: estudio transversal, cuantitativo, desarrollado en un hospital escuela de la región Centro-Oeste de Brasil. Se realizó a profesionales de enfermería a través de un cuestionario online con preguntas relacionadas con la seguridad del paciente, aplicado en septiembre de 2021. El análisis de los datos fue descriptivo. Resultado: Noventa profesionales participaron en el estudio, siendo 28(31,1%) enfermeros y 62(68,9%) técnicos de enfermería. En la evaluación de los ítems del cuestionario, el mejor porcentaje de aciertos fue sobre higiene de manos 84(93,3%), el ítem peor evaluado fue protocolo de identificación del paciente 45(50%). Las úlceras por presión se señalaron como el acontecimiento adverso más frecuente 28(33%). Conclusión: los resultados muestran que la formación continua es esencial para que los profesionales apliquen en la práctica los objetivos internacionales de seguridad del paciente.

Adverse events in anesthesia: Analysis of claims against anesthesiologists affiliated to an insurance fund in Colombia. Cross-sectional study / Eventos adversos en anestesia: Análisis de las reclamaciones contra anestesiólogos afiliados a un fondo de aseguramiento en Colombia. Estudio de corte transversal

Abstract Introduction: Prevention, identification, analysis and reduction of adverse events (AEs) are all activities designed to increase safety of care in the clinical setting. Closed claims reviews are a strategy that allows to identify patient safety issues. This study analyzes adverse events resulting in malpractice lawsuits against anesthesiologists affiliated to an insurance fund in Colombia between 2013-2019. Objective: To analyze adverse events in closed medicolegal lawsuits against anesthesiologists affiliated to an insurance fund between 2013-2019. Methods: Cross-sectional observational study. Convenience sampling was used, including all closed claims in which anesthesiologists affiliated to an insurance fund in Colombia were sued during the observation period. Variables associated with the occurrence of AEs were analyzed. Results: Overall, 71 claims were analyzed, of which 33.5% were due to anesthesia-related AEs. Adverse events were found more frequently among ASA I-II patients (78.9%), and in surgical procedures (95.8%). The highest number of adverse events occurred in plastic surgery (29.6%); the event with the highest proportion was patient death (43.7%). Flaws in clinical records and failure to comply with the standards were found in a substantial number of cases. Conclusions: When compared with a previously published study in the same population, an increase in ethical, disciplinary and administrative claims was found, driven by events not directly related to anesthesia. Most of the anesthesia-related events occurred in the operating room during surgical procedures in patients and procedures categorized as low risk, and most of them were preventable.

Resumen Introducción: La prevención, identificación, análisis y reducción de los eventos adversos (EA), son actividades direccionadas a incrementar la seguridad de la atención en el entorno clínico. El estudio de los casos cerrados es una estrategia que permite identificar problemas relacionados con la seguridad del paciente. En este estudio se analizan eventos adversos conducentes a procesos medicolegales cerrados contra anestesiólogos afiliados a un fondo de aseguramiento en Colombia entre 2013-2019. Objetivo: Analizar los eventos adversos en procesos medicolegales cerrados de anestesiólogos afiliados a un fondo de aseguramiento entre 2013-2019. Métodos: Estudio observacional de corte transversal. Se analizó una muestra a conveniencia en la que se incluyeron todos los casos cerrados en los que anestesiólogos afiliados a un fondo de aseguramiento en Colombia fueron objeto de reclamaciones en el período de observación. Se analizaron variables relacionadas con la presentación del EA. Resultados: Se analizaron 71 reclamaciones, de las cuales el 33,5 % fueron por EA relacionado con anestesia. Los eventos adversos se encontraron con mayor frecuencia en pacientes ASA I-II (78,9 %), y en procedimientos quirúrgicos (95,8 %). El mayor número de eventos adversos se presentó en cirugía plástica (29,6 %); el evento de mayor proporción fue el fallecimiento del paciente (43,7 %). En un importante número de casos se demostró fallos en el registro de la historia clínica e incumplimiento de normas. Conclusiones: En relación con un estudio publicado previamente en la misma población, se encuentra un incremento en los procesos éticos, disciplinarios y administrativos, motivados por eventos sin una relación directa con el acto anestésico. La mayoría de eventos adversos relacionados con anestesia se presentan en procedimientos quirúrgicos, en salas de cirugía, en pacientes y procedimientos catalogados como de bajo riesgo, y son en su mayoría prevenibles.

Eventos adversos sistémicos post-vacuna BCG. Serie de casos pediátricos

La vacuna BCG es clave para el control de la tuberculosis. En ocasiones se observan eventos adversos sistémicos causados por Mycobacterium bovis BCG; usualmente asociados a inmunodeficiencia. Describimos seis casos clínicos de niños vacunados con BCG al nacer, con complicaciones sistémicas post-vacunación. Método: Revisión de historias clínicas de pacientes con infección por M. bovis BCG atendidos en un hospital pediátrico, entre 2010 y 2019. Resultados: De 400 casos confirmados de infecciones por complejo Mycobacterium tuberculosis; ocho fueron identificados como M. bovis BCG; seis casos correspondieron a eventos adversos sistémicos post-vacuna BCG: dos con lesiones cutáneas a distancia, dos osteomielitis y dos infecciones generalizadas. En cinco de los seis pacientes se detectó una alteración de la respuesta inmune. Un paciente falleció por falla multiorgánica, uno se derivó y cuatro completaron 12 meses de tratamiento: dos meses de isoniacida, rifampicina, etambutol, y moxifloxacina, y 10 meses de isoniacida y rifampicina. Tuvieron buena tolerancia a los medicamentos, sin recaída a los dos años. Conclusión: La infección grave por M. bovis BCG es una rara complicación sistémica de la vacunación. Es razonable buscar defectos inmunológicos en los niños que desarrollan este tipo de eventos adversos.

The BCG vaccine is key to tuberculosis control. Systemic adverse events caused by Mycobacterium bovis BCG are occasionally observed; usually associated with immunodeficiency. In this report we describe six cases of children vaccinated with BCG at birth, with post-vaccination systemic complications. Method: retrospective review of medical records of patients with M. bovis BCG infection treated in a pediatric hospital between 2010 and 2019. Results: Of 400 confirmed cases of Mycobacterium tuberculosis complex infection, eight identified as M. bovis BCG, six corresponded to systemic adverse events post-BCG vaccine: two distant skin lesions, two osteomyelitis and two generalized infections. An altered immune response was detected in five of the six patients. One patient died of multiorgan failure, one was referred and four completed 12 months of treatment: two months of isoniazid, rifampin, ethambutol, and moxifloxacin, and 10 months of isoniazid and rifampin. They had good tolerance to medications, without relapse at two years. Conclusion Serious M. bovis BCG infection is a rare systemic complication of vaccination. It is reasonable to look for immunological defects in children who develop these types of adverse events.

Knowledge and attitude of materiovigilance among doctors in a tertiary care teaching hospital: A cross-sectional survey

Background: Post marketing surveillance of medical devices has to be done to avoid injuries and it is highly required to evaluate and ascertain the risks and benefits associated with the medical devices. Aims and Objectives: The aim of the study was to assess the knowledge and attitude about materiovigilance among doctors working in a tertiary care hospital. Materials and Methods: A cross-sectional study involving faculty and postgraduate residents of a tertiary care hospital using questionnaire which had 12 questions pertaining to attitude and knowledge of materiovigilance. Results: The survey questionnaire was sent to 300 health-care professionals among them, 259 respondents completely answered the questions. There were 96 teaching faculty, 163 were postgraduates residents. The average response rate was 86.3%. There was no statistical significant difference seen between the two groups (P = 0.85). Conclusion: More workshops and training programs need to be conducted to create awareness and reporting of adverse reactions due to medical instruments.

Rituximab, a Safer Option for Rheumatoid Arthritis: A Comparison of the Reported Adverse Events of Approved Monoclonal Antibodies

Monoclonal antibodies (mAbs), which are commonly used to treat rheumatoid arthritis (RA), have been linked to a variety of adverse events (AEs). The objective of the study was to compare the safety profiles of six FDA approved mAbs (sarilumab, tocilizumab, adalimumab, golimumab, infliximab, and rituximab) marketed for the treatment of RA. A systematic review of the literature was conducted using the databases PubMed, Cochrane Library, and Science Direct. The manuscript comprised a total of 23 clinical studies. The percentage of patients who had AEs was calculated and presented using box-whisker and forest plots. Infections and infestations were found to be the most common AEs in RA patients treated with mAbs. Raised alanine aminotransferase (ALT), aspartate aminotransferase (AST), upper respiratory tract infection (URTI), and nasopharyngitis were frequently reported. The most common AEs were reported with adalimumab. The highest percentage of patients reporting AEs was associated with golimumab (52%), while rituximab had the fewest AEs (4.9%). In conclusion, rituximab appears to be a safer treatment option for RA as it is found to be associated with a lower risk of AEs, particularly respiratory infections.

Effect of Obesity on the Recovery Profile After General Anesthesia in Children: A Prospective Cohort Study

Background: Obesity has become a serious problem not only in adult patients but also in pediatric patients. Aim: To evaluate whether obesity affects the recovery profile after general anesthesia in children. Participants: 40 children (aged 2–12 years) who underwent surgery under general anesthesia and had an American Society of Anesthesiologists (ASA) physical I and II. Methods: This prospective cohort study was conducted over a period of 3 months (January- April, 2021). The patients were divided into two groups according to body mass index (BMI): Group I comprised obese children (BMI ?95th for age percentile) (n=20) and Group II comprised children with a normal BMI (25– 75th for-age percentile) (n=20). Anesthesia induction and maintenance were performed as per standard guidelines in both the groups. Outcome: The recovery profile was evaluated with the following parameters: time to spontaneous ventilation, laryngeal mask airway removal time, time to open eyes, and postanesthesia care unit discharge time. Results: When the recovery profiles were compared, no significant differences were found between the groups. Time to spontaneous ventilation [mean difference (95% CI); 0.66 (0.09- 1.42); P=0.085], laryngeal mask airway removal time [MD (95% CI); 1.12 (0.06–2.22); P=0.057), time to open eyes [MD (95% CI) 0.66 (0.40–1.74); P=0.217], and post-anesthesia care unit discharge time [MD (95% CI) 3.60 (0.59-7.25); P=0.054] were higher in Group II; however, these differences lacked both statistical and clinical significance. Conclusion: The results suggest that obesity has no effect on the recovery profile after general anesthesia in children in our setting.

Awareness and outlook of health-care professionals regarding materiovigilance in a tertiary care teaching hospital in South Rajasthan

Background: Post-marketing surveillance regulates the safety, quality, and performance of medical devices (MDs). Medical professionals play a key role in the monitoring and reporting of MD Adverse Events (AEs). Since the launch of Materiovigilance (MV) Programme of India, very few published studies were found regarding reporting of MDAE. Aim and Objective: This study aims to know about awareness and outlook of medical professionals regarding MV. Materials and Methods: A cross-sectional study done among medical professionals of various specialties in a tertiary care teaching hospital in South Rajasthan. A pre-validated questionnaire was circulated to 200 doctors containing questions related to knowledge, attitude and practice of MV. Results: About 58.6% of the doctors came to know about the term MV during this study. About 76.7% of participants knew that MD could lead to an AE, but only 11.2% of the participants had the correct knowledge of how to report an AE related to MD. About 66.8% of participants had positive attitude regarding reporting of AE, 23.7% reported the event and 66.6% did not report as they found them mild. Conclusion: Majority of doctors had the knowledge about reporting of AEs, but they were largely unaware of the term MV. Knowledge regarding where to report is very limited. Despite adequate level of knowledge, reporting practices are very limited. Hence, there is a need for regular sensitization and training programs to foster the habit of reporting AE related to MD even if they are mild.