RESUMO
Polymyxins have been available since the 1960s, however, because of their adverse effects, their use has been reserved for the treatment of infections caused by multiresistant bacteria. The increase in the clinical experience acquired in recent years and the published medical literature have raised doubts about the information provided by the product, indicating the need to update dosage recommendations, pharmacokinetics and pharmacokinetic/pharmacodynamic information (PK/PD). In addition, differences in concentration and dose between the different products of colistin may lead to errors of indication/administration and pose a risk to patients. In 2013, the European Medicines Agency (EMA) commissioned the Committee for Medicinal Products for Human Use (CHPM) to review available data and to make updated recommendations on the use of colistin. This procedure yielded a first report in 2014. This review highlights critical safety and efficacy aspects, reviews the recent pharmacokinetic and stability advances, the available pharmaceutical forms in Chile, providing the schemes currently recommended by health care agencies and experts in the field.
Assuntos
Antibacterianos/administração & dosagem , Colistina/administração & dosagem , Antibacterianos/farmacocinética , Chile , Colistina/farmacocinética , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , HumanosRESUMO
Resumen Las polimixinas están disponibles desde la década de los 60; sin embargo, debido a sus efectos adversos su uso ha sido reservado para el tratamiento de infecciones provocadas por bacterias multi-resistentes. El aumento en la experiencia clínica adquirida en los últimos años y la literatura médica publicada han planteado dudas respecto de la información entregada del producto, poniendo en manifiesto la necesidad de actualizar las recomendaciones posológicas, su farmacocinética y la información farmacocinética/farmacodinámica. Además, las diferencias en cuanto a concentración y dosis entre los distintos productos del colistín pueden dar lugar a errores de indicación/administración y suponer un riesgo para los pacientes. El año 2013, la Agencia Europea de Medicamento (EMA) encargó al Comité de Productos Medicinales para uso Humano (CHPM) la revisión de los datos disponibles y que formulara recomendaciones actualizadas del uso de colistín. Dicho procedimiento arrojó un primer informe en 2014. Esta revisión destaca los aspectos críticos de seguridad y eficacia, revisa los recientes avances farmacocinéticos y de estabilidad, las formas farmacéuticas disponibles en Chile, proporcionando los esquemas actualmente recomendados por agencias sanitarias y expertos en el tema para distintos escenarios clínicos.
Polymyxins have been available since the 1960s, however, because of their adverse effects, their use has been reserved for the treatment of infections caused by multiresistant bacteria. The increase in the clinical experience acquired in recent years and the published medical literature have raised doubts about the information provided by the product, indicating the need to update dosage recommendations, pharmacokinetics and pharmacokinetic/pharmacodynamic information (PK/PD). In addition, differences in concentration and dose between the different products of colistin may lead to errors of indication/administration and pose a risk to patients. In 2013, the European Medicines Agency (EMA) commissioned the Committee for Medicinal Products for Human Use (CHPM) to review available data and to make updated recommendations on the use of colistin. This procedure yielded a first report in 2014. This review highlights critical safety and efficacy aspects, reviews the recent pharmacokinetic and stability advances, the available pharmaceutical forms in Chile, providing the schemes currently recommended by health care agencies and experts in the field.
Assuntos
Humanos , Colistina/administração & dosagem , Antibacterianos/administração & dosagem , Chile , Colistina/farmacocinética , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Antibacterianos/farmacocinéticaRESUMO
Surveillance of antimicrobial consumption is a central part in programs of antibiotic stewardship. However, in Chile there are no national data on antibiotic consumption representing a significant number of hospitals by clinical services. In 2013 a survey was sent to multiple Chilean hospitals to evaluate antimicrobial consumption in medical services (MS), surgery services (SS) and critical care units (ICU). We used the standardized methodology recommended by the WHO, using the number of DDD/100 days beds. In the MS and SS beta-lactam and no beta-lactam antibiotics commonly used were evaluated. In the ICU consumption vancomycin, linezolid, imipenem, merope-nem, colistin and tigecycline was evaluated. Fifteen hospitals reported the density of antimicrobial consumption. Ceftriaxone and cloxacillin were the most commonly used antibiotics in general services (average cloxacillin 4,9 DDD/100 bed days in MS and 8,0 DDD/100 in SS; ceftriaxone 13,5 DDD/100 in MS and 16,7 DDD/100 in SS). In the SS there was also a significant consumption of metronidazole (average 14,5 DDD/100 bed days). In the ICU there was an important variability of consumption of selected antibiotics. This study reports the average and range of antibiotic consumption in MS, SS, and ICU from a significant number of hospitals in the country, during 2013. This information allows hospitals to compare their consumption of antibiotics with a significant sample of Chilean hospitals. Analysis of this information should consider a careful interpretation according to the sample shown here and the reality of each hospital.
Assuntos
Antibacterianos/uso terapêutico , Revisão de Uso de Medicamentos/estatística & dados numéricos , Hospitais/estatística & dados numéricos , Chile , Prescrições de Medicamentos/estatística & dados numéricos , Farmacorresistência Bacteriana , Humanos , Fatores de TempoRESUMO
La vigilancia del consumo de antimicrobianos es parte central en los programas de utilización de antimicrobianos. Sin embargo, en Chile no se conocen datos del consumo de antibacterianos por servicios clínicos, que representen un número importante de hospitales. En el año 2013 se envió una encuesta a múltiples hospitales chilenos para evaluar el consumo de antimicrobianos en los servicios clínicos de Medicina (SM), Cirugía (SC) y Unidades de Pacientes Críticos (UPC). Para ello se usó la metodología estandarizada recomendada por la OMS de DDD/100 días camas. En los SM y SC se evaluaron antibacterianos β-lactámicos y no β-lactámicos de uso frecuente. En las UPC se evaluó el consumo de vancomicina, linezolid, imipenem, meropenem, colistín y tigeciclina. Se obtuvo resultados de 15 hospitales, los cuales informaron la densidad de consumo de antimicrobianos de los servicios mencionados. Ceftriaxona y cloxacilina fueron los antimicrobianos más utilizados en servicios generales (promedio cloxacilina 4,9 DDD/100 días cama en SM y 8,0 DDD/100 en SC; ceftriaxona 13,5 DDD/100 en SM y 16,7 DDD/100 en SC). En los SC se agrega además un consumo importante de metronidazol (promedio 14,5 DDD/100 días cama). En las UPC destaca la variabilidad de consumo de antimicrobianos seleccionados. Este estudio reporta el promedio y rangos de consumo de antibacterianos en SM, SC y UPC de un número importante de hospitales del país durante el año 2013. Esta información permite a los hospitales comparar su consumo de antibacterianos con una muestra significativa de hospitales chilenos. El análisis de esta información debe considerar una cuidadosa interpretación de acuerdo a la muestra aquí representada y la realidad de cada uno de los hospitales.
Surveillance of antimicrobial consumption is a central part in programs of antibiotic stewardship. However, in Chile there are no national data on antibiotic consumption representing a significant number of hospitals by clinical services. In 2013 a survey was sent to multiple Chilean hospitals to evaluate antimicrobial consumption in medical services (MS), surgery services (SS) and critical care units (ICU). We used the standardized methodology recommended by the WHO, using the number of DDD/100 days beds. In the MS and SS beta-lactam and no beta-lactam antibiotics commonly used were evaluated. In the ICU consumption vancomycin, linezolid, imipenem, merope-nem, colistin and tigecycline was evaluated. Fifteen hospitals reported the density of antimicrobial consumption. Ceftriaxone and cloxacillin were the most commonly used antibiotics in general services (average cloxacillin 4,9 DDD/100 bed days in MS and 8,0 DDD/100 in SS; ceftriaxone 13,5 DDD/100 in MS and 16,7 DDD/100 in SS). In the SS there was also a significant consumption of metronidazole (average 14,5 DDD/100 bed days). In the ICU there was an important variability of consumption of selected antibiotics. This study reports the average and range of antibiotic consumption in MS, SS, and ICU from a significant number of hospitals in the country, during 2013. This information allows hospitals to compare their consumption of antibiotics with a significant sample of Chilean hospitals. Analysis of this information should consider a careful interpretation according to the sample shown here and the reality of each hospital.
Assuntos
Humanos , Revisão de Uso de Medicamentos/estatística & dados numéricos , Hospitais/estatística & dados numéricos , Antibacterianos/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Fatores de Tempo , Chile , Farmacorresistência BacterianaRESUMO
Five issues were reviewed in depth at the 2014 annual meeting of Colaborative Group Against Bacterial Resistance and the antecedents and conclusions are detailed in this document. I.- News in CLSI 2014: the difficulties and implications on its implementation at the local level were reviewed and recommendations were set. II.- Criteria for determining the incidence of multi-resistant microorganism in critical care units where indicators and monitoring methodology for better quantification of microorganisms were defined. III.- Quality requirements were established to be considered by the professionals involved in the selection of antimicrobials in the hospital. IV.- Transfer policies, screening and contact precautions for the control of transmission of multiresistant bacteria. V.- Recommendations for health facilities when a carbapenemase producing enterobacteriacea is detected, in a checklist format for rapid deployment in hospitals without endemia of these agents. These are suggestions that arise from the joint work of specialists from many hospitals that do not represent consensus or recommendation, but may help to control the resistance level of each health facility in the country.
Assuntos
Antibacterianos/farmacologia , Infecções Bacterianas/microbiologia , Farmacorresistência Bacteriana , Controle de Infecções , Chile , Comportamento Cooperativo , Humanos , Testes de Sensibilidade MicrobianaRESUMO
Five issues were reviewed in depth at the 2014 annual meeting of Colaborative Group Against Bacterial Resistance and the antecedents and conclusions are detailed in this document. I.- News in CLSI 2014: the difficulties and implications on its implementation at the local level were reviewed and recommendations were set. II.- Criteria for determining the incidence of multi-resistant microorganism in critical care units where indicators and monitoring methodology for better quantification of microorganisms were defined. III.- Quality requirements were established to be considered by the professionals involved in the selection of antimicrobials in the hospital. IV.- Transfer policies, screening and contact precautions for the control of transmission of multiresistant bacteria. V.- Recommendations for health facilities when a carbapenemase producing enterobacteriacea is detected, in a checklist format for rapid deployment in hospitals without endemia of these agents. These are suggestions that arise from the joint work of specialists from many hospitals that do not represent consensus or recommendation, but may help to control the resistance level of each health facility in the country.
En la reunión anual del Grupo Colaborativo de Resistencia Bacteriana del año 2014 se revisaron en profundidad cinco tópicos cuyos antecedentes y conclusiones se detallan en este documento. Los temas fueron: I.- Novedades del CLSI 2014: se revisaron las dificultades e implicancias de su implementación a nivel local y se establecen recomendaciones. II.- Criterios para la determinación de incidencia de microoganismos multi-resistentes en unidades de pacientes críticos, donde se definieron los indicadores y la metodología de vigilancia para una mejor cuantificación del problema. III.- Se establecieron requisitos de calidad a considerar por los profesionales que participan en la selección de antimicrobianos en el hospital. IV.- Se discutieron las políticas de traslado, tamizaje y precauciones de contacto para el control de la transmisión de bacterias multiresistentes. V.- Se establecieron recomendaciones para los establecimientos de salud frente a la pesquisa de una enterobacteria productora de carbapenemasa en formato de lista de chequeo para la implementación rápida en hospitales sin endemia de estos agentes. Estas sugerencias nacen del trabajo conjunto de especialistas de muchos hospitales, no representan un consenso o normativa pero pueden ser de ayuda para el control de la resistencia en cada establecimiento de salud del país.