Percepção dos profissionais de enfermagem sobre manejo de reação infusional a antineoplásicos: estudo qualitativo / Perception of nursing professionals on the management of infusion reactions to antineoplastics: qualitative study

Identificar a percepção dos profissionais de enfermagem sobre o manejo de reação infusional imediata a antineoplásicos. Método: Trata-se de um estudo descritivo de caráter exploratório com abordagem qualitativa realizado em um hospital no Rio Grande do Sul. Resultados: Todos os participantes afirmaram saber identificar uma reação infusional. Após a identificação da reação, nota-se que a maioria obedeceu a uma ordem de condutas a serem realizadas. Quanto aos cuidados para prevenção das reações infusionais, a maioria dos participantes mencionou a administração de medicamentos pré-quimioterápicos, como antialérgicos e antieméticos. Conclusão: Os achados demonstram que a maioria dos profissionais sabe reconhecer e manejar, porém há a necessidade de treinamentos e padronização das ações.(AU)

To identify the perception of nursing professionals about the management of immediate infusion reactions to antineoplastic drugs. Method: This is a descriptive, exploratory study with a qualitative approach carried out in a hospital in Rio Grande do Sul. Results: All the participants said they knew how to identify an infusion reaction. After identifying the reaction, it was noted that the majority followed an order of conduct to be carried out. As for precautions to prevent infusion reactions, most of the participants mentioned the administration of pre-chemotherapy drugs, such as anti-allergic and anti-emetic drugs. Conclusion: The findings show that most professionals know how to recognize and manage them, but there is a need for training and standardization of actions.(AU)

Identificar la percepción de los profesionales de enfermería sobre el manejo de las reacciones infusionales inmediatas a medicamentos antineoplásicos. Método: Se trata de un estudio descriptivo, exploratorio, con abordaje cualitativo, realizado en un hospital de Rio Grande do Sul. Resultados: Todos los participantes afirmaron saber identificar una reacción a la infusión. Después de identificar la reacción, la mayoría siguió un orden de conducta. En cuanto a las precauciones para prevenir las reacciones a la infusión, la mayoría de los participantes mencionó la administración de fármacos prequimioterápicos, como antialérgicos y antieméticos. Conclusión: Los hallazgos muestran que la mayoría de los profesionales saben reconocerlas y manejarlas, pero es necesaria la formación y la estandarización de actuaciones.(AU)

A novel agent for myeloma causing toxic keratopathy, belantamab mafodotin: a case report and literature review / Belantamabe-mafodotina, um novo agente para mieloma, causando ceratopatia tóxica: relato de caso e revisão da literatura

ABSTRACT A 60-year-old-male with refractory relapsed multiple myeloma presented with redness, pain, foreign body sensation, and blurred vision in both eyes that gradually increased after his third belantamab mafotodin infusion. Biomicroscopy revealed bilateral microcyst-like epithelial changes and epithelial crystal-like deposits, whereas in vivo confocal microscopy revealed intraepithelial and subepithelial hyperreflective deposits in corneal epithelium. Belantamab mafodotin therapy was discontinued for seven weeks due to corneal toxicity, which cleared progressively. We aim to demonstrate belantamab mafodotin-related corneal toxicity that may be detected using slit lamp and in vivo confocal biomicroscopy.

RESUMO Um homem de 60 anos, diagnosticado com mieloma múltiplo recidivante refratário, apresentou vermelhidão, dor, sensação de corpo estranho e visão turva em ambos os olhos, aumentando gradualmente após sua terceira infusão de belantamabe mafodotina. À biomicroscopia, foram observadas alterações epiteliais bilaterais semelhantes a microcistos e depósitos epiteliais semelhantes a cristais. A microscopia confocal in vivo revelou depósitos hiper-refletivos intraepiteliais e subepiteliais na córnea. Devido à toxicidade corneana, a terapia com belantamabe mafodotina foi interrompida por sete semanas e a toxicidade foi gradualmente resolvida. Nosso objetivo é demonstrar os achados à biomicroscopia confocal in vivo e à lâmpada de fenda da toxicidade corneana relacionada ao belantamabe mafodotina.

ERG and OCT abnormalities in retinoblastoma after melphalan intravitreous injection / Anormalidades do ERG e OCT em um caso de retinoblastoma após injeção intravítrea de melfalan

ABSTRACT The authors report full-field electroretinogram and optical coherence tomography findings of intravitreal melphalan retinal toxicity. An 18-month-old girl with unilateral group D retinoblastoma was evaluated with light-adapted 3 full-field electroretinogram protocol and optical coherence tomography (I-Stand optical coherence tomography, Optovue) after treatment with intravitreal melphalan for active vitreous seeds. After the third injection, the child developed retinal pigment epithelial changes near the injection site. The photopic response of the full-field electroretinogram standard flash cones showed a decrease in amplitude responses of waves a and b in the affected eye compared to the contralateral eye. Optical coherence tomography showed loss of photoreceptors and outer nuclear layers in the affected eye. Melphalan toxicity is dose-dependent, and despite its treatment benefits, it can affect vision. Our case shows an updated, in-depth retinal toxicity assessment of intravitreal melphalan in the human retina with optical coherence tomography and its correlation with electroretinogram changes.

RESUMO Os autores relatam os achados de eletrorretinograma de campo total e tomografia de coerência óptica (OCT) da toxicidade retiniana ao melfalan intravítreo. Menina de 18 meses com retinoblastoma foi avaliada com fases fotópicas do eletrorretinograma de campo total e tomografia de coerência óptica após o tratamento com melfalan intravítreo. Após a terceira injeção, a criança desenvolveu alterações do epitélio pigmentar da retina próximo ao local da injeção. A resposta fotópica do eletrorretinograma de campo total mostrou diminuição da amplitude das respostas das ondas a e b no olho afetado comparado com o olho sadio. A tomografia de coerência óptica mostrou alterações significativas nas camadas retinianas externas no olho comprometido. A toxicidade do melfalan é dose dependente e, apesar dos benefícios terapêuticos, podem causar alterações retinianas significativas. Este caso demonstra uma avaliação atual e aprofundada da toxicidade retiniana do melfalan intravítreo na retina humana através da tomografia de coerência óptica e sua correlação com as alterações no eletrorretinograma.

When the fever will not stop, stop the pills! A case report

ABSTRACT Neuroleptic malignant syndrome (NMS) is a neurologic emergency potentially fatal. This rare side effect is most commonly associated with first-generation antipsychotics and less frequently with atypical or second-generation antipsychotics. The diagnosis relies on both clinical and laboratory criteria, with other organic and psychiatric conditions being ruled out. CASE REPORT: A 39-year-old female patient, who is institutionalized and completely dependent, has a medical history of recurrent urinary infections and colonization by carbapenem-resistant Klebsiella pneumoniae. Her regular medication regimen included sertraline, valproic acid, quetiapine, risperidone, lorazepam, diazepam, haloperidol, baclofen, and fentanyl. The patient began experiencing dyspnea. Upon physical examination, she exhibited hypotension and a diminished vesicular murmur at the right base during pulmonary auscultation. Initially, after hospitalization, she developed high febrile peaks associated with hemodynamic instability, prompting the initiation of antibiotic treatment. Despite this, her fever persisted without an increase in blood inflammatory parameters, and she developed purulent sputum, necessitating antibiotherapy escalation. The seventh day of hospitalization showed no improvement in symptoms, suggesting NNMS as a differential diagnosis. All antipsychotic and sedative drugs, as well as antibiotherapy, were discontinued, after which the patient showed significant clinical improvement. CONCLUSION: Antipsychotic agents are commonly employed to manage behavioral changes linked to various disorders. However, their severe side effects necessitate a high degree of vigilance, the cessation of all medications, and the implementation of supportive care measures. A prompt and accurate diagnosis of NMS is crucial to alleviating the severe, prolonged morbidity and potential mortality associated with this syndrome.

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.

Um raro caso de vasculite leucocitoclástica induzida por oxacilina / A rare case of oxacillin-induced leukocytoclastic vasculitis

A vasculite leucocitoclástica é uma patologia cujos mecanismos estão associados ao processo de inflamação vascular. Estima-se que até 24% dos casos de vasculite estão relacionados ao uso de fármacos, sendo os antimicrobianos beta-lactâmicos um dos grupos farmacológicos comumente associados a este desfecho adverso. A oxacilina, uma penicilina semissintética, possui um anel beta-lactâmico que confere atividade biológica e está associada com maior frequência a relatos de vasculite leucocitoclástica. No entanto, casos semelhantes relacionados a esse antimicrobiano são raros, sendo identificados apenas três casos na literatura. Diante desse contexto, relatamos um quarto caso de vasculite leucocitoclástica em um homem de 56 anos, em tratamento com oxacilina, que desenvolveu a vasculite no 3º dia de uso do antimicrobiano. Além da suspensão da oxacilina, ele foi tratado com 125 mg/dia de metilprednisolona endovenosa por sete dias, seguido de 20 mg/dia de prednisona oral por quatro dias, resultan-do em remissão satisfatória das lesões cutâneas e ausência de novos desfechos adversos. Este caso corrobora a possível relação causal entre o uso de oxacilina e o desenvolvimento da vasculite leucocitoclástica, apesar de sua ocorrência ser rara. A resposta favorável às intervenções terapêuticas, incluindo a suspensão da oxacilina e o uso de corticosteroides, destaca a eficácia dessas abordagens no tratamento dessa complicação (AU).

Leukocytoclastic vasculitis is a pathology whose mechanisms are associated with the process of vascular inflammation. It is estimated that up to 24% of the cases of vasculitis are drug-related, with beta-lactam antimicrobials be-ing one of the pharmacological groups commonly associated with this adverse outcome. Oxacillin, a semisynthetic penicillin, has a beta-lactam ring that confers biological activity and is most frequently associated with reports of leukocytoclastic vasculitis. However, similar cases related to this antimicrobial are rare, with only three cases identified in the literature. Against this background, we report a fourth case of leukocytoclastic vasculitis in a 56-year-old man, on oxacillin treatment, who developed the vasculitis on the 3rd day of antimicrobial use. In addition to oxacillin suspension, he was treated with 125 mg/day of intravenous methylprednisolone for seven days, followed by 20 mg/day of oral prednisone for four days, resulting in satisfactory remission of the skin lesions and no new adverse outcomes. This case provides further evidence supporting the potential causal relationship between the use of oxacillin and the development of leukocytoclastic vasculitis, albeit a rare occurrence. The positive response to therapeutic interventions, such as oxacillin suspension and corticosteroid treatment, underscores the effectiveness of these approaches in addressing this complication (AU),

Managerial Decision-Making of Nurses in Hospitals: creation and validation of a simulation scenario / Tomada de Decisão Gerencial do Enfermeiro da Área Hospitalar: construção e validação de cenário de simulação / Toma de Decisiones Gerenciales del Enfermero en el Área Hospitalaria: construcción y validación de un escenario de simulación

Abstract Objective: to build and validate a clinical simulation scenario on hospital nurse managerial decision-making competence for undergraduate nursing students. Method: a descriptive and methodological study was carried out in a higher education institution, with the participation of 10 judges and five players. To do so, the conceptual simulation model proposed by Jeffries and standards of the International Nursing Association for Clinical Simulation and Learning were used to prepare the scenario and the checklist. Results: the scenario was called "Managerial decision-making of nurses in the face of adverse events in a hospital". The scenario script and checklist were built for validation. The checklist was face- and content-validated. Afterward, judges used the checklist to validate the scenario, which, in its final version, was composed of Prebriefing (seven items), Scenario in Action (18 items) and Debriefing (seven items). Conclusion: the scenario proved to be a teaching strategy that anticipates the reality of future nurses, bringing them the self-confidence to perform their activities and helping them to act critically and reflectively during decision-making processes.

Resumo Objetivo: construir e validar um cenário de simulação clínica sobre a competência tomada de decisão gerencial do enfermeiro hospitalar para estudantes de graduação em enfermagem. Método: estudo descritivo e metodológico realizado em uma instituição de ensino superior, com a participação de 10 juízes e cinco atores. Utilizou-se o modelo conceitual de simulação proposto por Jeffries e guias padronizadas da International Nursing Association for Clinical Simulation in Learning para a elaboração do cenário e do checklist. Resultados: o cenário ficou denominado como "Tomada de decisão gerencial do enfermeiro diante de eventos adversos no contexto hospitalar". Construiu-se o script do cenário e o checklist para a sua validação. Realizou-se validação de face e conteúdo do checklist. Posteriormente, juízes de posse do checklist, validaram o cenário que, em sua versão final, ficou composto por Prebriefing (sete itens), Cenário em Ação (18 itens) e Debriefing (sete itens). Conclusão: o cenário mostrou-se uma estratégia de ensino capaz de antecipar a realidade do futuro enfermeiro, trazendo autoconfiança na execução de suas atividades, contribuindo para agir de forma crítica e reflexiva durante o processo de tomada de decisão.

Resumen Objetivo: construir y validar un escenario de simulación clínica sobre la competencia en la toma de decisiones gerenciales del enfermero hospitalario para estudiantes del grado en enfermería. Método: estudio descriptivo y metodológico realizado en una institución de educación superior, con la participación de 10 jueces y cinco actores. Se utilizó el modelo conceptual de simulación propuesto por Jeffries y guías estandarizadas de la International Nursing Association for Clinical Simulation in Learning para la elaboración del escenario y del checklist. Resultados: el escenario se denominó "Toma de decisiones gerenciales del enfermero ante eventos adversos en el contexto hospitalario". Se construyó el script del escenario y el checklist para su validación. Se realizó la validez aparente y el contenido del checklist. Posteriormente, los jueces en posesión del checklist, validaron el escenario que, en su versión final, quedó compuesto por Prebriefing (siete ítems), Escenario en Acción (18 ítems) y Debriefing (siete ítems). Conclusión: el escenario demostró ser una estrategia de enseñanza capaz de anticipar la realidad del futuro enfermero, trayendo autoconfianza en la ejecución de sus actividades, contribuyendo para actuar de forma crítica y reflexiva durante el proceso de toma de decisiones.

Predicción de toxicidad de la quimioterapia y radioterapia en el paciente oncológico quirúrgico

Fundamento la toxicidad asociada a los tratamientos de quimioterapia y radioterapia eleva la morbilidad y la mortalidad en los pacientes oncológicos. Objetivo diseñar un modelo predictivo de toxicidad de la quimioterapia y la radioterapia en el paciente oncológico quirúrgico. Métodos estudio analítico, de casos y controles, en pacientes oncológicos quirúrgicos que cumplieron los criterios de inclusión para la predicción de toxicidad preoperatoria, en el periodo enero a diciembre de 2022, en el Hospital Provincial Docente Oncológico María Curie, de Camagüey. Mediante el paquete estadístico Statistical Package for the Social Sciences, se seleccionó una muestra aleatoria de 334 pacientes, 197 sin toxicidad (grupo control) y 137 con toxicidad (grupo de estudio). Se realizó estimación de predictores de toxicidad mediante regresión logística binaria. Se seleccionó el modelo de mejor ajuste. Resultados el modelo en el paso tres predice un porcentaje global de 83,5 % con respecto a los valores observados. La sensibilidad resultó ser de 81,8; y la especificidad, 84,8. El modelo presentó buen poder discriminativo. Las variables en la ecuación fueron: hipertensión arterial, fracción de eyección del ventrículo izquierdo y anemia. La comparación de la predicción con la realidad, mediante curva Receiver Operating Characteristic determinó un área bajo la curva de 0,901. Conclusión se obtuvo una función de regresión logística que permitió la estimación de la probabilidad de toxicidad en pacientes oncológicos quirúrgicos electivos, la cual proporcionó una herramienta para su predicción desde el preoperatorio.

Foundation the toxicity associated with chemotherapy and radiotherapy treatments increases morbidity and mortality in cancer patients. Objective to design a predictive model of chemotherapy and radiotherapy toxicity in surgical cancer patients. Methods analytical, case-control study, in surgical oncology patients who met the inclusion criteria for the prediction of preoperative toxicity, from January to December 2022, at the María Curie Provincial Teaching Oncology Hospital in Camagüey. Using the Statistical Package for the Social Sciences, a random sample of 334 patients was selected, 197 without toxicity (control group) and 137 with toxicity (study group). Toxicity predictors were estimated using binary logistic regression. The model with the best fit was selected. Results the model in step three predicts an overall percentage of 83.5% with respect to the observed values. The sensitivity turned out to be 81.8; and the specificity, 84.8. The model presented good discriminative power. The variables in the equation were: arterial hypertension, left ventricular ejection fraction, and anemia. The comparison of the prediction with reality, using the Receiver Operating Characteristic curve, determined an area under the curve of 0.901. Conclusion a logistic regression function was obtained that allowed the estimation of the toxicity probability elective surgical cancer patients, which provided a tool for its prediction from the preoperative period.

Manejo das irregularidades menstruais secundárias ao uso de contraceptivos ­ análise das recomendações atuais / Management of menstrual irregularities secondary to contraceptive use ­ analysis of current recommendations

As irregularidades menstruais representam uma série de desordens na quantida- de, duração, frequência ou regularidade do sangramento uterino. Entre suas cau- sas destaca-se o sangramento secundário ao uso de anticoncepcionais, uma razão frequente de descontinuidade dos contraceptivos, podendo aumentar as taxas de gestações não planejadas. Boa parte dos contraceptivos pode levar a mudanças no padrão de sangramento uterino, e a abordagem inicial do sangramentos irregula- res inclui a avaliação de outras possíveis causas, o reforço do uso correto da medi- cação, a tranquilização da paciente quanto à benignidade do quadro e à tendência a melhora com a continuidade do uso. Os anti-inflamatórios podem ser usados como estratégia inicial, e, não havendo resposta satisfatória, há alternativas espe- cíficas para cada método. Este trabalho visa identificar as recomendações atuais sobre o manejo do sangramento anormal decorrente de contraceptivos, por meio de revisão narrativa de estudos publicados sobre o tema nos últimos vinte anos.

Abnormal uterine bleeding represents a series of disorders in the amount, du- ration, frequency and or regularity of uterine bleeding. Among its causes, uterine bleeding secondary to the use of contraceptives stands out as a frequent reason for contraceptive discontinuity, which could lead to unplanned pregnancies. Most contraceptives can cause changes in the pattern of uterine bleeding, and the ini- tial approach of the abnormal bleeding includes assessing other possible cau- ses, reinforcing the correct use of medication, and reassuring the patient about the benignity of the condition and the tendency to improve with the continuity of the treatment. Anti-inflammatory drugs can be used as an initial strategy, and, if there is no satisfactory answer, there are specific alternatives for each contracep- tive method. This work aims to identify them current recommendations on the management of abnormal bleeding resulting from contraceptives use, through a narrative review of studies published on the subject in the last twenty years.

EGFR inhibitors: clinical aspects, risk factors and biomarkers for acneiform eruptions and other mucosal and cutaneous adverse effects

Abstract The frequency of the use of drugs that act on the epidermal growth factor receptor (EGFR) is increasing, with the consequent onset of cutaneous toxicity, specifically acneiform eruption. The authors extensively review the topic, focusing on describing how these drugs can affect the skin and its appendages, that is, the pathophysiology that encompasses the cutaneous toxicity related to the use of EGFR inhibitors. In addition, it was possible to list the risk factors that may be associated with adverse effects of these drugs. Based on this recent knowledge, the authors expect to aid in the management of patients who are more vulnerable to toxicity, reduce morbidities, and improve the quality of life of patients undergoing treatment with EGFR inhibitors. Other issues related to the toxicity of EGFR inhibitors, such as the clinical aspects of the acneiform eruption grades, and other different types of cutaneous and mucosal reactions, are also included in the article.

Safety and effectiveness of adding fentanyl or sufentanil to spinal anesthesia: systematic review and meta-analysis of randomized controlled trials

Abstract Introduction Spinal infusions of either fentanyl or sufentanil have been reported in international reports, articles, and scientific events worldwide. This study aimed to determine whether intrathecal fentanyl or sufentanil offers safety in mortality and perioperative adverse events. Methods MEDLINE (via PubMed), EMBASE, CENTRAL (Cochrane library databases), gray literature, hand-searching, and clinicaltrials.gov were systematically searched. Randomized controlled trials with no language, data, or status restrictions were included, comparing the effectiveness and safety of adding spinal lipophilic opioid to local anesthetics (LAs). Data were pooled using the random-effects models or fixed-effect models based on heterogeneity. Results The initial search retrieved 4469 records; 3241 records were eligible, and 3152 articles were excluded after reading titles and abstracts, with a high agreement rate (98.6%). After reading the full texts, 76 articles remained. Spinal fentanyl and sufentanil significantly reduced postoperative pain and opioid consumption, increased analgesia and pruritus. Fentanyl, but not sufentanil, significantly reduced both postoperative nausea and vomiting, and postoperative shivering; compared to LAs alone. The analyzed studies did not report any case of in-hospital mortality related to spinal lipophilic opioids. The rate of respiratory depression was 0.7% and 0.8% when spinal fentanyl or sufentanil was added and when it was not, respectively. Episodes of respiratory depression were rare, uneventful, occurred intraoperatively, and were easily manageable. Conclusion There is moderate to high quality certainty that there is evidence regarding the safety and effectiveness of adding lipophilic opioids to LAs in spinal anesthesia.

Reacciones adversas medicamentosas en ancianos de Matanzas, Cuba 2014-2019 / Adverse drug reactions in the elderly of Matanzas, Cuba 2014-2019

Resumen Objetivo: Caracterizar las sospechas de reacciones adversas a medicamentos que se presentaron en los adultos mayores en Matanzas, en el periodo 2014 al 2019. Materiales y Método: Estudio de serie de casos en Farmacovigilancia (FV). Se revisó la base de datos de reportes de sospecha de reacciones adversas a los medicamentos de la Unidad Coordinadora Provincial de Farmacovigilancia, entre 2014 y 2019. Resultados: Se evaluaron un total de 1926 reportes de reacciones adversas por medicamentos en ancianos, representaron el 24,3 % del total. Predominaron las mujeres (56,7 %) y el grupo de edad entre 60 y 69 años (51,4%). Prevaleció la erupción cutánea (13,4 %). Los antimicrobianos y los antiinflamatorios no esteroideos, fueron los que se asociaron más con las RAM en piel, así como del sistema digestivo. La tos estuvo relacionada con el captopril. Predominaron las reacciones adversas por medicamentos de baja frecuencia (55,2%), moderadas (83,8%) y las probables (77,1%) según imputabilidad. Conclusiones: El perfil de seguridad en ancianos en la provincia de Matanzas muestra un predominio de reacciones adversas frecuentes, moderadas y probables en mujeres con edades entre 60 a 69 años. Los antimicrobianos, los inhibidores de la enzima convertidora de angiotensina y los antiinflamatorios no esteroideos fueron los fármacos más notificados por los médicos y farmacéuticos produciendo síntomas a nivel del sistema digestivo y la piel.

Abstract Objective: To characterize suspected adverse drug reactions that occurred in older adults in Matanzas, from 2014 to 2019. Materials and methods: Pharmacovigilance (FV) case series study. The database of reports of suspected adverse drug reactions of the Provincial Pharmacovigilance Coordinating Unit, between 2014 and 2019, was reviewed. Results: A total of 1926 reports of adverse drug reactions in the elderly were evaluated, representing 24, 3% of the total. Women (56.7%) and the age group between 60 and 69 years (51.4%) predominated. Skin rash prevailed (13.4%). Antimicrobials and non-steroidal anti-inflammatory drugs were the ones most associated with ADRs in the skin, as well as in the digestive system. Cough was related to captopril. Adverse drug reactions of low frequency (55.2%), moderate (83.8%) and probable (77.1%) prevailed according to immutability. Conclusions: The safety profile in the elderly in the province of Matanzas shows a predominance of frequent, moderate and probable adverse reactions in women aged between 60 and 69 years. Antimicrobials, angiotensin-converting enzyme inhibitors and non- steroidal anti-inflammatory drugs were the drugs most reported by doctors and pharmacists, producing symptoms at the level of the digestive system and the skin.

Reacciones adversas a múltiples antibióticos / Adverse drug reactions to multiple antibiotics

Resumen La información sobre reacciones adversas es fundamental para conocer la seguridad real de los medicamentos comercializados. Existen casos de pacientes con síndrome de intolerancia a múl tiples drogas, una entidad poco reportada, la que puede presentarse cuando en un mismo paciente ocurren reacciones adversas a más de dos medicamentos no relacionados farmacológicamente. Se describe el caso de una mujer con diagnóstico de endocarditis por Staphylococcus aureus multisensible, que cursó con reacciones adversas a cinco antibióticos estructuralmente no relacionados y con mecanismos de acción diferentes, en dos internaciones consecutivas. Las reacciones fueron secundarias a cefazolina (tricitopenia), vancomicina (injuria renal), daptomicina (elevación de creatina fosfoquinasa) y linezolid (hepatotoxicidad) en la primera internación, y a cotrimoxazol (plaquetopenia) en la segunda. En todos los casos se observó daño transitorio en diferentes sistemas de órganos. Finalmente, se otorgó alta hospitalaria con clindamicina sin nuevas intercurrencias hasta finalizar tratamiento. Este caso podría corresponder al síndrome antes mencionado o a una entidad aún no caracterizada.

Abstract Adverse reaction reporting is essential to understand the actual safety of marketed medicines. There are cases of patients with multidrug intolerance syndrome, an under-reported entity, which can occur when adverse reactions to more than two pharmacologically unrelated drugs occur in the same patient. We describe the case of a woman diagnosed with multisensitive Staphylococcus aureus endocarditis who experienced adverse reactions to five structurally unrelated antibiotics with different mechanisms of action in two consecutive hospitalisations. The reactions were secondary to cefazolin (tricytopenia), vancomycin (renal injury), daptomycin (elevated creatine phosphokinase) and linezolid (hepatotoxicity) in the first hospitalization, and to cotrimoxazole (thrombocytopenia) in the second. Transient damage to different organ systems was observed in all cases. Finally, hospital discharge was granted with clindamycin without further intercurrences until treatment was completed. This case could cor respond to the aforementioned syndrome or to an as yet uncharacterized entity.

Effect of double dose plateletpheresis on target yield and donor platelet recovery

Abstract Introduction The demand for apheresis platelets has increased in the recent past and the shrinking donor pool has shifted the trend to collection of double-dose or higher yield of platelets. Objective The present study aimed to determine the effect of double-dose plateletpheresis on the target yield and donor platelet recovery. Methods The study was conducted on 100 healthy plateletpheresis donors, 50 of whom were in the study group, which underwent double-dose plateletpheresis (DDP), and 50 of whom were in the control group for single-donor plateletpheresis. Pre- and post-procedure samples of donors were subjected to a complete blood count. The DDP product was sampled for platelet yield and then split into two parts. Platelet yield, collection efficiency, collection rate, recruitment factor and donor platelet loss were calculated. Results The mean platelet yield in the SDP was 4.09 ± 1.15 × 1011 and in the DDP, 5.93 ± 1.04 × 1011. There was a significant correlation between the pre-donation platelet count and platelet yield. The total of platelets processed for the SDP were 5.42 ± 1.08 × 1011 and for the DDP, 7.94 ± 0.77 × 1011. The collection efficiency was 71.93 ± 25.14% in the SDP and 72.94 ± 16.28% in the DDP, while the collection rates were 0.78 × 1011 and 0.94 × 1011 per minute, respectively. The average recruitment factor observed was 0.98 in the SDP, while it was 0.99 in the DDP. The mean platelet loss observed in the SDP was 35.55 ± 8.53% and in the DDP, 37.76 ± 8.65%. Conclusion The double-dose plateletpheresis supplements the platelet inventory in developing countries where the apheresis donor pool is limited. It is prudent to ensure stringent donor selection criteria for donors donating high-yield platelet products, thus enhancing donor safety and retention.

Frequency And Factors Associated With Adverse Reactions After Administration of Inactivated COVID-19 Vaccine Among Health Workers

ABSTRACT Background: The 2019 coronavirus (COVID-19) has precipitated a significant public health crisis. Our study aimed to evaluate the prevalence and risk factors associated with adverse reactions to the inactivated CoronaVac vaccine. Methods: The study involved voluntary health workers who received CoronaVac vaccine. We documented the sociodemographic information of 2,019 participants who volunteered for our study. Of these, 1,964 and 1,702 participants were interviewed by phone 1 month after the first and second dose, respectively, during which they were queried about any adverse reactions. Results: Within the first week after the first dose, adverse reactions were observed in 856 (43.3%) participants, with 133 (6.7%) experiencing them during the second week, and 96 (4.9%) people at the end of the first month. For the second dose, 276 individuals (16.2%) reported adverse reactions. The prevalence of both local and systemic adverse events ranged from 9.5-11.2% overall. Fatigue was the most common adverse reaction overall, while pain at the injection site was the most frequent local adverse reaction. Conclusions: The evaluation of both systemic and local side effects revealed no significant adverse reactions to the inactivated CoronaVac vaccine (Sinovac Life Sciences, Beijing, China). Our study found that the incidence of systemic and local adverse responses to the CoronaVac vaccination was lower than the rates reported in studies involving the recombinant adenovirus type-5, BNT162b1, and ChAdOx1nCoV-19 COVID-19 vaccines, all of which underwent the World Health Organization LULUC/PQ evaluation process.

Cross-cultural adaptation and content validity of the Adverse Events Associated with Nursing Practices instrument / Adaptación intercultural y validez del contenido del instrumento Eventos Adversos Asociados a las Prácticas de Enfermería / Adaptação transcultural e validade de conteúdo do instrumento Eventos Adversos Associados às Práticas de Enfermagem

ABSTRACT Objective: To conduct the cross-cultural adaptation and evaluate the evidence of content validity of the Adverse Events Associated with Nursing Practices instrument in the Brazilian context. Method: Psychometric study, conducted between June 2021 and February 2023, following the stages of the Patient-Reported Outcomes Measurement Information System protocol. Semantic, idiomatic, experimental and conceptual equivalences were evaluated, along with content validity evidence, considering Content Validity Ratio (CVR) parameters, with the participation of 25 experts. Results: A Brazilian version with 55 items was obtained, demonstrating good linguistic equivalence to the original version (agreement rate=99.2%), and adjustments in the items writing. CVR values remained above 0.60. Cognitive testing indicated good understanding, confirmed by the 31 participants in this stage, with a short application time (average = 17 minutes). Conclusion: The final version of the instrument showed good linguistic equivalence, strong evidence of content validity and a good response process in the Brazilian context.

RESUMEN Objetivo: Realizar la adaptación transcultural y evaluar las evidencias de validez de contenido del instrumento Eventos Adversos Asociados a las Prácticas de Enfermería en el contexto brasileño. Método: Estudio psicométrico, realizado entre junio de 2021 y febrero de 2023, según los pasos del protocolo del Patient-Reported Outcomes Measurement Information System. Se evaluaron equivalencias semánticas, idiomáticas, experimentales y conceptuales, además de evidencias de validez de contenido, considerando parámetros de Relación de Validez de Contenido (RCV), con 25 participaciones de especialistas. Resultados: Se obtuvo una versión brasileña con 55 ítems, buena equivalencia lingüística a la versión original (tasa de acuerdo=99,2%), y ajustes en la redacción de los ítems. Los valores de RCV se mantuvieron por encima de 0,60. Las pruebas cognitivas indicaron una buena comprensión, confirmada por los 31 participantes en este paso de la investigación, con un tiempo de aplicación corto (promedio = 17 minutos). Conclusión: La versión final del instrumento mostró buena equivalencia lingüística, fuerte evidencia de validez de contenido y buen proceso de respuesta en el contexto brasileño.

RESUMO Objetivo: Realizar a adaptação transcultural e avaliar as evidências de validade de conteúdo do instrumento Eventos Adversos Associados às Práticas de Enfermagem no contexto brasileiro. Método: Estudo psicométrico, realizado entre junho de 2021 e fevereiro de 2023, de acordo com as etapas do protocolo Patient-Reported Outcomes Measurement Information System. Avaliadas as equivalências semântica, idiomática, experimental e conceitual, além das evidências de validade de conteúdo, considerando parâmetros de Content Validity Ratio (CVR), com participação de 25 especialistas. Resultados: Obteve-se versão brasileira com 55 itens, boa equivalência linguística à versão original (taxa de concordância=99,2%), e ajustes na redação dos itens. Os valores de CVR mantiveram-se acima de 0,60. A testagem cognitiva indicou boa compreensão, confirmada pelos 31 participantes dessa etapa, com curto tempo de aplicação (média = 17 minutos). Conclusão: A versão final do instrumento apresentou boa equivalência linguística, fortes evidências de validade de conteúdo e bom processo de resposta no contexto brasileiro.

Trackers for Adverse Events in Child Mental Health: descriptive analysis using the global trigger tool

Abstract The goal of this study is to identify the global trigger tool trackers used to place the adverse drug events presented in children that use psychotropic drugs accompanied by Child-adolescent Psychosocial Care Centers. This is a descriptive study carried out with the secondary data of 112 child care records that began in January 2017 in two Child-adolescent Psychosocial Care Centers. A median of medicine per child was 1.71 and among the most used we were to risperidone 100%, followed by valproic acid and periciazine with 16% each. A total of 42 adverse drug events were found in 36 medical records, being agitation 29.7% and agressive 16.2%, being the most frequent, and in 45.2% of infants presenting only one event. 50 were trackers detected in 83.3%, two records that identified adverse drug events. In 38.8% were found only one tracker, the most found ones were: combination of psychotropic medicines 32%, abrupt reduction of medicine dose 22% and abrupt cessation of medicine 12%. Finally, the present study showed that the global trigger tool evidenced adverse drug events by means of the detection of trackers in children and that it had to offer interventions to improve the quality of psychiatric therapy within two community services.

Adverse effects of cannabinoid use: what is the safety paradigm? / Efeitos adversos do uso dos canabinoides: qual o paradigma de segurança?

ABSTRACT BACKGROUND AND OBJECTIVES: Interest in the use of marijuana (Cannabis sativa) for medicinal purposes has increased exponentially in recent decades, and the plant and its derivatives are becoming more frequently found in prescriptions for patients with chronic pain. All prescription drugs and illicit substances have adverse effects, even those from plants, fruits, and flowers, as has been well established with the use of tobacco, alcohol, and opium. Marijuana is no exception. The purpose of this study was to review and synthesize the evidence related to the adverse effects promoted by plant-derived cannabinoids, and the implications for the safety of using these substances in pain patients. CONTENTS: A narrative review was conducted based on articles published in scientific journals indexed in Pubmed and Scielo between the years 2000 and 2022. CONCLUSION: The evidence is still contradictory and weak on many aspects of adverse effects and clearly there is a need for further research and advances towards a more detailed elucidation of these effects for both non-medical and medical cannabis use. Screening and monitoring of such use, identifying situations of vulnerability to mental illness and dependence, with careful surveillance for adverse effects, is critical.

RESUMO JUSTIFICATIVA E OBJETIVOS: O interesse na utilização da maconha (Cannabis sativa) com fins medicinais aumentou de forma exponencial nas últimas décadas e a planta e seus derivados vêm se tornando mais frequentemente encontrados nas prescrições médicas de pacientes com dor crônica. Todos os fármacos prescritos e substâncias ilícitas têm efeitos adversos, mesmo aquelas provenientes de plantas, frutas e flores, como já ficou bem estabelecido com o uso do tabaco, álcool e ópio. A maconha não é exceção. O objetivo deste estudo foi revisar e sintetizar as evidências relacionadas aos efeitos adversos promovidos pelos canabinoides derivados da planta, e às implicações sobre a segurança do uso destas substâncias em pacientes com dor. CONTEÚDO: Foi realizada uma revisão narrativa baseada em artigos publicados em revistas científicas indexadas no Pubmed e Scielo, entre os anos de 2000 e 2022. CONCLUSÃO: As evidências ainda são contraditórias e frágeis em relação a muitos aspectos dos efeitos adversos e claramente há a necessidade de mais pesquisas e avanços para uma elucidação mais detalhada destes efeitos tanto para o uso não medicinal quanto médico de cannabis. É fundamental uma triagem e monitoramento desse uso, identificando situações de vulnerabilidade a doenças mentais e dependência, com cuidadosa vigilância de efeitos adversos.

Prevalence and underreporting of immunization errors in childhood vaccination: results of a household survey / Prevalencia y subregistro de errores de inmunización en la vacunación infantil: resultados de una encuesta de hogares / Prevalência e subnotificação de erros de imunização na vacinação de crianças: resultados de um inquérito domiciliar

ABSTRACT Objective: To investigate underreporting of immunization errors based on vaccination records from children under five years of age. Method: An epidemiological, cross-sectional analytical study, carried out through a household survey with 453 children aged 6 months to 4 years in three municipalities in Minas Gerais in 2021. A descriptive analysis was carried out, and the prevalence of the error was calculated per 100 thousand doses applied between 2016 and 2021. The magnitude was estimated of the association between variables by prevalence and 95% Confidence Intervals (95%CI). To analyze underreporting, State reporting records were used. Results: A prevalence of immunization errors was found to be 41.9/100,000 doses applied (95%CI:32.2 - 51.6). The highest prevalence occurred between 2020 (50.0/100,000 doses applied) and 2021 (78.6/100,000 doses applied). The most frequent error was an inadequate interval between vaccines (47.2%) associated with adsorbed diphtheria, tetanus and pertussis (DTP) vaccine (13.7/100,000) administration. Vaccination delay was related to immunization errors (7.55 95% CI:2.30 - 24.80), and the errors found were underreported. Conclusion: The high prevalence of underreported errors points to a worrying scenario, highlighting the importance of preventive measures.

RESUMEN Objetivo: Investigar el subregistro de errores de vacunación a partir de los registros de vacunación de niños menores de cinco años. Método: Estudio epidemiológico, analítico transversal, realizado mediante encuesta de hogares con 453 niños de 6 meses a 4 años en tres municipios de Minas Gerais en 2021. Análisis descriptivo y cálculo de la prevalencia de error por 100 mil dosis aplicadas entre 2016 y 2021. La magnitud de la asociación entre las variables se estimó mediante prevalencia e intervalos de confianza del 95% (IC95%). Para analizar el subregistro se utilizaron los registros de notificaciones estatales. Resultados: Se encontró una prevalencia de errores de inmunización de 41,9/100.000 dosis aplicadas (IC95%: 32,2 - 51,6). La prevalencia más alta se produjo entre 2020 (50,0/100.000 dosis aplicadas) y 2021 (78,6/100.000 dosis aplicadas). El error más frecuente fue un intervalo inadecuado entre vacunas (47,2%) asociado a la administración de la vacuna adsorbida contra la difteria, el tétanos y la tos ferina (DTP) (13,7/100.000). El retraso en la vacunación estuvo relacionado con errores de vacunación (7,55 IC 95%: 2,30 - 24,80), y los errores encontrados fueron subreportados. Conclusión: La alta prevalencia de errores no reportados apunta a un escenario preocupante, destacando la importancia de las medidas preventivas.

RESUMO Objetivo: Investigar a subnotificação de erros de imunização a partir dos registros de vacinação da caderneta de crianças menores de cinco anos. Método: Estudo epidemiológico, transversal analítico, realizado por inquérito domiciliar com 453 crianças de 6 meses a 4 anos em três municípios de Minas Gerais em 2021. Realizaram-se a análise descritiva e o cálculo da prevalência do erro por 100 mil doses aplicadas entre 2016 e 2021. Estimou-se a magnitude da associação entre as variáveis pela prevalência e Intervalos de Confiança 95% (IC95%). Para a análise da subnotificação, utilizaram-se os registros de notificação do Estado. Resultados: Encontrou-se uma prevalência de erros de imunização de 41,9/100.000 doses aplicadas (IC95%:32,2 - 51,6). A maior prevalência ocorreu entre 2020 (50,0/100.000 doses aplicadas) e 2021 (78,6/100.000 doses aplicadas). O erro mais frequente foi intervalo inadequado entre vacinas (47,2%) associado à administração da vacina adsorvida difteria, tétano e pertussis (DTP) (13,7/100.000). O atraso vacinal relacionou-se ao erro de imunização (7,55 IC95%:2,30 - 24,80), e os erros encontrados foram subnotificados. Conclusão: A alta prevalência de erros subnotificados aponta para um cenário preocupante, ressaltando a importância de medidas preventivas.

Atualização dos rastreadores para detecção de eventos adversos a medicamentos em pacientes hematológicos / Update of triggers for detection of adverse drug events in hematologic patients / Actualización de los rastreadores para detectar eventos farmacológicos adversos en pacientes hematológicos

Resumo: A utilização de rastreadores para a busca ativa e detecção de eventos adversos a medicamentos (EAM) tem ganhado espaço nos serviços de farmacovigilância. Assim, o objetivo principal do estudo foi propor uma nova lista de rastreadores para ser empregada em um centro especializado em hematologia do Rio de Janeiro, Brasil. A atualização da lista de rastreadores consistiu na revisão da lista atual, com a exclusão e inclusão de rastreadores. Para verificar o desempenho da nova lista de rastreadores, realizou-se um estudo transversal em que os novos rastreadores foram utilizados para investigar a ocorrência de EAM em pacientes atendidos na emergência ou hospitalizados no período de janeiro a março de 2022. Para cada suspeita de EAM identificada, caracterizaram-se o perfil do paciente e as reações adversas a medicamentos (RAM) quanto à causalidade e gravidade. O desempenho dos rastreadores e sua capacidade de captação de EAM foram calculados por meio dos indicadores: frequência do rastreador por 100 prontuários, frequência de EAM por 100 prontuários e valor preditivo positivo (VPP). Para avaliar o desempenho global da nova lista proposta, calculou-se o VPP. Foram identificadas 374 prescrições de rastreadores em 186 prontuários. Os mais eficientes na detecção de possíveis EAM foram: lidocaína, loperamida, bisacodil, filgrastim e clister de glicerina. O VPP global da nova lista sugerida foi 48% contra 10% da lista anterior. Este estudo demonstrou a importância de uma lista de rastreadores atualizada para o monitoramento dos EAM e o aprimoramento da assistência prestada.

Abstract: The use of triggers for the active search and detection of adverse drug events (ADEs) has been gaining ground within pharmacovigilance services. Thus, the main objective of the study was to propose a new list of triggers to be used in a center specialized in hematology in Rio de Janeiro, Brazil. The update of the list of triggers consisted of revising the current list, with the exclusion and inclusion of new triggers. To verify the performance of the new list of triggers, a cross-sectional study was conducted in which the new triggers were used to investigate the occurrence of ADEs in patients attended in the emergency unit or hospitalized from January to March 2022. For each suspected ADEs, the patient's profile and adverse drug reactions (ADRs) were characterized regarding causality and severity. The performance of the triggers and their ability to capture ADEs were estimated using the following indicators: frequency of the trigger per 100 medical records, frequency of ADEs per 100 records, and positive predictive value (PPV). To evaluate the overall performance of the proposed new list, the PPV was estimated. A total of 374 prescriptions for triggers were identified in 186 medical records. The most efficient in the detection of possible ADEs were: lidocaine, loperamide, bisacodyl, filgrastim and glycerin clyster. The overall PPV of the new suggested list was 48% versus 10% of the previous list. This study demonstrated the importance of an updated list of triggers for the monitoring of ADEs and improvement of the care provided.

Resumen: El uso de rastreadores en la búsqueda y detección activa de eventos adversos de medicamentos (EAM) viene ganando espacio dentro de los servicios de farmacovigilancia. Por lo tanto, el objetivo principal de este estudio fue proponer una nueva lista de rastreadores que se utilizarán en un centro de hematología especializado en Río de Janeiro, Brasil. La actualización de la lista de rastreadores consistió en la revisión de la lista actual, con la exclusión e inclusión de rastreadores. Para verificar el desempeño de la nueva lista de rastreadores, se realizó un estudio transversal en el que se utilizaron los nuevos rastreadores para investigar la aparición de EAM en pacientes atendidos en urgencias u hospitalizados en el periodo de enero a marzo de 2022. Para cada sospecha de EAM identificados, el perfil del paciente y las reacciones adversas a medicamentos (RAM) se caracterizaron por su causalidad y gravedad. El desempeño de los rastreadores y su capacidad para capturar EAM se calcularon mediante los indicadores: frecuencia del rastreador por cada 100 registros médicos, frecuencia de EAM por cada 100 registros médicos y valor predictivo positivo (VPP). Para evaluar el desempeño general de la nueva lista propuesta, se calculó el VPP. Se identificaron 374 recetas de rastreadores en 186 registros médicos. Los más eficientes en la detección de posibles EAM fueron lidocaína, loperamida, bisacodilo, filgrastim y enema de glicerina. El VPP general de la nueva lista sugerida fue del 48% frente al 10% de la lista anterior. Este estudio demostró la importancia de una lista actualizada de rastreadores para monitorear EAM y mejorar la atención brindada.