Latin American Consensus for the Evaluation and Treatment of Patients With Metastatic/Locally Advanced Urothelial Carcinoma.

PURPOSE: Urothelial cancer accounts for approximately 3% of new cancer cases worldwide, with a high burden of disease in countries with medium and low human development indexes where its incidence and mortality are increasing. The purpose of this consensus is to develop statements on the evaluation and treatment of locally advanced and metastatic urothelial carcinoma that would further guide the clinical practice in Latin America. METHODS: A systematic review of the literature was conducted by an independent team of methodologists. Then, a modified Delphi method was developed with clinical specialists from different Latin American countries. RESULTS: Forty-two consensus statements, based on evidence, were developed to address the staging, the evaluation (suitability for chemotherapy, risk assessment, and biomarkers), and systemic treatment (first-line and subsequent therapies) of locally advanced or metastatic urothelial carcinoma. The statements made in this consensus are suggested practice recommendations in the Latin American context; however, the importance of a complete and individualized patient evaluation as a guide for therapeutic selection is highlighted. The availability and affordability of support tools for the evaluation of the disease, as well as specific therapies, may limit the application of the best practices suggested. RECOMMENDATIONS: Therapeutic decisions need to be tailored to the context-specific clinical setting and availability of resources. Local research is promoted to improve outcomes for patients with this challenging cancer in Latin America.

Premezclados como alternativa para el uso seguro de medicamentos intravenosos en escenarios de atención en salud / Premixed products, an alternative for safe intravenous medications use in health care settings / As pré-misturas como alternativa para o uso seguro de drogas intravenosas em ambientes de saúde

RESUMEN Objetivo: presentar el panorama de errores de medicación, los recursos asociados a la preparación de medicamentos intravenosos y el uso de premezclados en la aten ción en salud. Metodología: se realizaron búsquedas en diferentes bases de datos, sin límite de fecha o tipo de estudio. Adicionalmente se realizó un análisis para estimar los costos, validando con expertos los recursos en central de mezclas. Resultados: los errores de medicación son un error médico común a nivel global. Los datos disponi bles son heterogéneos, pero sugieren que los errores de medicación pueden ser una causa considerable de morbilidad y mortalidad en ciertas poblaciones y contextos, con intervenciones adicionales, estancias hospitalarias prolongadas, mayores costos de atención y reducción en la probabilidad de que el tratamiento sea oportuno y eficaz. En medicinas intravenosas resultan escenarios de mayor gravedad y mayor nivel de costos. Los costos laborales anuales para una central de mezclas en Colombia se estiman entre 281,5 y 422,3 millones de pesos. La estandarización, como parte de los fármacos premezclados proporciona menor riesgo de contaminación, menor posibilidad de error en la preparación, menor incidencia de complicaciones rela cionadas con la terapia, disminución del desperdicio, mejora en la oportunidad de dispensación, optimización en el trabajo de los equipos de farmacia y reducción de costos asociados con este proceso. Conclusiones: el uso de premezclados, como parte de un programa de reducción de errores de medicación, puede mejorar los indicadores de calidad en administración de medicamentos y garantizar un uso más seguro de la terapia intravenosa.

SUMMARY Objective: To present an overview of medication preparation and administration errors, the resources implied in the preparation of intravenous medications, and the use of premixed drugs in healthcare settings. Methodology: We performed a litera ture review without limits by date or type of study. Additionally, analysis and vali dation by pharmaceutical experts were carried out to estimate the use of resources and related costs. Results: The available heterogeneous data suggest that medication errors are a significant cause of morbidity and mortality in specific populations and settings. Error medications cause additional interventions, prolonged hospitalization, higher costs of care, and a reduction in the treatment probability of success. Errors involving intravenously administered drugs have more severe consequences and generate higher costs. Annual labor costs for centralized medication mixing in Colombia are estimated between $281.5 and $422.3 million. Premixed drugs decrease the risk of contamination, the possibility of error in the preparation, and the incidence of complications related to therapy. Also, its use is related to the reduc tion of waste, improvement in the timing of dispensing, optimizing the pharmacy team, and reducing costs associated with this process. Conclusions: The use of premixes as part of a program to reduce medication errors can improve the quality indicators in drug administration and guarantee a safer use of intravenous therapy.

RESUMO Objetivo: apresentar o panorama dos erros de medicação, os recursos associados ao preparo de medicamentos intravenosos e o uso de pré-misturas na assistência à saúde. Metodologia: as buscas foram realizadas em diferentes bases de dados, sem limite de data ou tipo de estudo. Além disso, foi realizada uma análise para estimar os custos, validando com especialistas os recursos no centro de mistura. Resultados: erros de medicação são um erro médico comum globalmente. Os dados disponíveis são heterogêneos, mas sugerem que os erros de medicação podem ser uma causa significativa de morbidade e mortalidade em certas populações e contextos, com intervenções adicionais, internações hospitalares mais longas, custos mais altos de atendimento e probabilidade reduzida de que o tratamento seja oportuno e eficaz. Nos medicamentos intravenosos, resultam cenários de maior gravidade e maior nível de custos. Os custos anuais de mão de obra para uma usina de mistura na Colômbia são estimados entre 281,5 e 422,3 milhões de pesos. A padronização, como parte dos medicamentos pré-misturados, proporciona menor risco de contaminação, menor possibilidade de erro no preparo, menor incidência de complicações relacionadas à terapêutica, redução de desperdícios, melhoria na oportunidade de dispensação, otimização no trabalho das equipes. da farmácia e redução dos custos associados a este processo. Conclusões: o uso de pré-misturas, como parte de um programa de redução de erros de medicação, pode melhorar os indicadores de qualidade na admi nistração de medicamentos e garantir um uso mais seguro da terapia intravenosa.

Efecto de terapias farmacológicas para el control glicémico en pacientes con diabetes mellitus tipo 2 en los desenlaces vasculares / Effect of pharmacological therapies for glycemic control in patients with type 2 diabetes mellitus on vascular outcomes

Resumen Introducción: en los últimos 5 años la publicación de conocimiento relacionado con la enfermedad vascular y la diabetes mellitus tipo 2 (DT2) ha ido en aumento. Sin embargo, debido a la ausencia de una revisión que recopilara todos los desenlaces vasculares de la DT2, la presente revisión de literatura tiene como objetivo agrupar todos los desenlaces vasculares relacionados con la DT2 y describir cómo la terapia farmacológica hipoglicemiante puede ser eficaz para lograr el control de estos desenlaces. Los eventos cardiovasculares como desenlace principal demuestran que los medicamentos antidiabéticos innovadores como la empagliflozina y la liraglutida pueden agregar un beneficio significativo para pacientes con DT2. Materiales y métodos: búsqueda sistemática de la literatura, de la cual se obtuvieron 141 referencias, después de eliminar duplicados, para la tamización pareada. Posterior a esto, se identificaron 2l referencias que cumplían con los criterios de inclusión para ser considerados en el análisis. Resultados: el efecto de un buen control glucémico, sobre los resultados clínicos, específicamente en la progresión de la enfermedad renal diabética, ha sido objetivo de múltiples estudios a gran escala, tanto en pacientes diabéticos tipo 1 como en diabéticos tipo 2. Los desenlaces micro y macrovasculares son los principales desenlaces de la DMT2, que incrementan la incidencia de comorbilidades y representan, a su vez, una mayor morbilidad. Conclusiones: dentro de las principales causas de morbilidad y mortalidad de los pacientes con DT2, se encuentran las relacionadas con daño vascular, en especial enfermedad cardiovascular y compromiso renal. En este contexto, el tratamiento farmacológico de la diabetes mellitus se ha enfocado en encontrar medicamentos que reduzcan de manera significativa los eventos cardiovasculares y que al mismo tiempo retrasen la aparición de nefropatía o su progresión. Las tiazolidinedionas, los inhibidores de DPP4 (alogliptina, saxagliptina y sitagliptina), la insulina glargina y degludec han demostrado seguridad cardiovascular, pero no beneficio cardiovascular incremental en pacientes con DT2 que tienen alto riesgo de enfermedad cardiovascular aterosclerótica.

Abstract Introduction: In the last 5 years the publication of knowledge related to vascular disease and diabetes mellitus type 2 (DT2) has been increasing. However, due to the absence of a review that collects all the vascular outcomes of T2D, the current review of the literature aims to group all vascular outcomes related to T2D and describe how hypoglycemic drug therapy can be effective for the control of these outcomes. Cardiovascular events as the main outcome show that innovative antidiabetic drugs such as empagliflozin and liraglutide can add significant benefits for patients with T2D. Materials and methods: Systematic search of the literature, from which 141 references were obtained, after eliminating duplicates, for paired screening. Subsequently, 21 references were identified that met the inclusion criteria to be considered in the analysis. Results: The effect of good glycemic control on clinical outcomes, specifically in the progression of diabetic kidney disease, has been the objective of multiple large-scale studies, both in type 1 diabetic patients and type 2 diabetics and macrovascular outcome of the primary DMT2, increasing the incidence of comorbidities and in turn representing greater morbidity. Conclusions: Among the main causes of morbidity and mortality of patients with T2D, are those with vascular damage, especially cardiovascular disease and renal involvement. In this context, the pharmacological treatment of diabetes mellitus has focused on finding drugs that reduce the importance of cardiovascular events and that at the same time delay the onset of nephropathy or its progression. Thiazolidinediones, DPP4 inhibitors (alogliptin, saxagliptin and sitagliptin), insulin glargine and degludec have demonstrated cardiovascular safety, but not incremental cardiovascular benefits, in patients with T2D who are at high risk of atherosclerotic cardiovascular disease.

[Adequate diagnosis of acquired hemophilia A]. / Importancia de la orientación diagnóstica en hemofilia A adquirida.

Acquired hemophilia A (AHA) is a rare and life-threatening autoimmune hemorrhagic disorder where autoantibodies are developed against factor VIII. An early diagnosis is challenging and mandatory: an immediate hemostatic control is required to reduce morbidity and mortality. Laboratory features of AHA are: presence of autoantibodies against factor VIII, prolonged activated partial thromboplastin time (with normal prothrombin time and thrombin time) and decreased factor VIII levels. In some cases, the results of laboratory tests may be incorrect due to errors in analysis, blood extraction or manipulation of samples; also worth of consideration are limitations in the measurement range and low sensitivity of the tests. This review highlights the importance of adequate screening in patients with suspected AHA to make an adequate diagnosis and reduce overall fatal outcomes.

Recomendaciones basadas en evidencia para el manejo del dolor oncológico (revisión de la literatura) / Evidence-based recommendations for the management of cancer pain (review of the literature)

Resumen: Objetivo: Describir recomendaciones basadas en evidencia para el manejo integral del dolor oncológico. Metodología: Revisión temática basada en una búsqueda de guías de práctica clínica para el manejo integral del dolor oncológico, desde el 2012 al 2017. De las referencias incluidas, se recolectó información relacionada con la evaluación, clasificación, indicaciones de tratamiento, principios de manejo farmacológico y no farmacológico. Resultados: Se incluyeron 12 estudios relacionados con el manejo del dolor oncológico, después de la eliminación de duplicados. Se realizó una síntesis y análisis de aspectos relevantes enfocados en: 1) evaluación del dolor; 2) clasificación del dolor oncológico; 3) principios y metas de manejo del dolor, así como el tratamiento farmacológico y no farmacológico; y 4) seguimiento. Se recomienda que los pacientes con dolor leve (puntaje de 1 a 3) que no hayan sido tratados con opioides previamente, sean tratados con acetaminofén o antiinflamatorios no esteroideos (AINEs). Para pacientes con dolor leve que no responden a analgésicos no opioides y para pacientes con intensidad del dolor mayor o igual a 4, se recomiendan opioides de acción corta. Conclusión: El dolor oncológico inadecuadamente tratado constituye un problema de salud pública, por lo que es primordial una adecuada evaluación para asegurar de manera oportuna un manejo efectivo desde el diagnóstico, seguimiento a intervalos regulares y cuando se inicie un nuevo tratamiento.

Abstract: Objective: To describe the evidence-based recommendations for the integral management of oncological pain. Methodology: Literature review based on a search of clinical practice guidelines for the comprehensive management of oncological pain, from 2012 to 2017. From the included references, it was obtained information related the evaluation, classification, indications of treatment, principles of pharmacological management and not pharmacological. Results: We included 12 studies related for the management of oncological pain, after the elimination of duplicates. The synthesis and analysis of relevant aspects focused on 1) pain assessment; 2) classification of oncological pain; 3) principles and goals of pain management, as well as pharmacological and non-pharmacological management; and 4) follow-up. It is recommended that patients with mild pain (score of 1 to 3) who have not been previously treated with opioids, should be treated with acetaminophen or NSAIDs. For patients with mild pain who do not respond to non-opioids and for patients with pain intensity greater than or equal to four, short-acting opioids are recommended. Conclusion: Oncological pain inadequately treated constitutes a public health problem, which is why adequate evaluation is essential to ensure proper management from the moment of diagnosis, with follow-up at regular intervals and when a new treatment is initiated, in order to find best balance between efficacy and safety of the interventions, and maximizing functionality and improving the patient's quality of life. The management of oncological pain therefore requires a multidisciplinary approach.

Importancia de la orientación diagnóstica en hemofilia A adquirida / Adequate diagnosis of acquired hemophilia A

Acquired hemophilia A (AHA) is a rare and life-threatening autoimmune hemorrhagic disorder where autoantibodies are developed against factor VIII. An early diagnosis is challenging and mandatory: an immediate hemostatic control is required to reduce morbidity and mortality. Laboratory features of AHA are: presence of autoantibodies against factor VIII, prolonged activated partial thromboplastin time (with normal prothrombin time and thrombin time) and decreased factor VIII levels. In some cases, the results of laboratory tests may be incorrect due to errors in analysis, blood extraction or manipulation of samples; also worth of consideration are limitations in the measurement range and low sensitivity of the tests. This review highlights the importance of adequate screening in patients with suspected AHA to make an adequate diagnosis and reduce overall fatal outcomes.

Recomendaciones basadas en la evidencia para el manejo del dolor neuropático (revisión de la literatura) / Evidence-based recommendations for the management of neuropathic pain (review of the literature)

Objetivo: Sintetizar, mediante una revisión de la literatura, las recomendaciones actuales en el manejo del dolor neuropático. Metodología: Revisión temática basada en una búsqueda de literatura altamente sensible para la identificación de guías de práctica clínica y revisiones sistémicas de la literatura enfocadas en diagnóstico y manejo del dolor neuropático, desde 2012 a 2017. De las referencias incluidas, se obtuvo información relacionada con definiciones, consideraciones relevantes, indicaciones y objetivos del tratamiento, tanto farmacológico como no farmacológico y criterios de remisión. Resultados: Se incluyeron 34 guías de práctica clínica relevantes para el manejo del dolor neuropático. Se realizó una síntesis de aspectos relevantes enfocados en: 1) las herramientas de tamización disponibles para la identificación y clasificación del dolor neuropático; 2) el diagnóstico y seguimiento de las pruebas de confirmación; 3) principios del manejo del dolor, así como el manejo farmacológico y no farmacológico de primera, segunda y tercera línea, de acuerdo con la localización de las lesiones; y 4) seguimiento. Los tratamientos de primera línea más comúnmente recomendados influyen los antidepresivos tricíclicos, α2δ-ligandos (pregabalina y gabapentina) y los inhibidores selectivos de la recaptación de serotonina/noradrenalina. Conclusión: El dolor neuropático es una condición común en la práctica clínica, donde el médico no especialista en dolor realizará el diagnóstico basado en una historia clínica detallada y examen físico dirigido. El tratamiento debe ser multidisciplinario e iniciarse precozmente con fármacos de primera línea

Objective: To synthesize, through a literature review, the current recommendations in the management of neuropathic pain. Methodology: Thematic review based on a highly sensitive literature search for the identification of clinical practice guidelines and systematic reviews, focused on diagnosis and management of neuropathic pain, from 2012 to 2017. From the included references, it was obtained information related to definitions, relevant considerations, indications and objectives of treatment, both pharmacological and non-pharmacological, as well as remission criteria. Results: We included 34 relevant clinical practice guidelines for the management of neuropathic pain. The synthesis of relevant aspects focused on: 1) the screening tools available for identification and classification of neuropathic pain; 2) diagnosis and follow-up of confirmation tests; 3) pain management principles, as well as pharmacological and non-pharmacological management as first, second and third line, according to the location of lesions; and 4) follow-up. The most commonly recommended first-line treatments include tricyclic antidepressants, α2δ-ligands (pregabalin and gabapentin), and selective serotonin / noradrenaline reuptake inhibitors. Conclusion: Neuropathic pain is a common condition in clinical practice, where the non-pain specialist will perform the diagnosis based on a detailed clinical history and directed physical exam. The treatment must be multidisciplinary and begin early with first-line drugs