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1.
Rev. Bras. Saúde Mater. Infant. (Online) ; 21(4): 1075-1082, Oct.-Dec. 2021. tab, graf
Article in English | LILACS | ID: biblio-1360720

ABSTRACT

Abstract Objectives: to evaluate the performance of a trigger tool in identifying adverse drug events (ADE) in hospitalized children. Methods: a retrospective cohort study review on 133 medical records at a federal maternal and child reference hospital in Rio de Janeiro in 2016. A list of 14 triggers was developed to detect ADE in the pediatric population. Three steps were performed: (1) search for triggers; (2) selection of suspected cases of ADE and (3) final determination of ADE by experts' consensus. Results: 360 triggers were identified in 100 hospitalizations (75.2%), with an average of 2.7 triggers/ hospitalization. The most frequent triggers were "abrupt medication stop" (79.7%); "antiemetics use" (8.9%) and "laxatives use" (7.2%); while the "diphenhydramine use", "phytomenadione use" and "excessive sedation/lethargy/fall/hypotension" obtained the highest performance indicating ADE every time they occurred. Thirty-one ADE were identified in 12.8% of the hospitalizations; 11 (35.5%) ADE were detected without the aid of the triggers thus, pruritus and diarrhea were the most frequent. Conclusion: the trigger tool proved to be useful in identifying ADE in hospitalized children, especially if high performance and high frequency triggers are used in identifying the events. The inclusion of the triggers "diarrhea" and "pruritus", may favor the identification of ADE in patients at pediatric wards.


Resumo Objetivos: avaliar o desempenho de uma ferramenta de rastreamento de eventos adversos a medicamentos (EAM) em crianças hospitalizadas. Métodos: estudo de coorte retrospectivo com revisão de 133 prontuários de hospital federal de referência materno infantil no Rio de Janeiro, em 2016. Uma lista de 14 rastreadores foi usada para detecção de EAM na população pediátrica. Foram realizadas 3 etapas: (1) busca de rastreadores; (2) seleção dos casos suspeitos de EAM e (3) determinação final do EAM por consenso entre especialistas. Resultados: foram identificados 360 rastreadores em 100 internações (75,2%), com média de 2,7 rastreadores/internação. Os rastreadores mais frequentes foram "interrupção abrupta da medicação" (79,7%); "uso de antieméticos" (8,9%) e "uso de laxantes" (7,2%) enquanto que "uso de difenidramina", "uso de fitomenadiona" e "excesso de sedação/letargia/queda/hipotensão" obtiveram o maior rendimento indicando EAM em todas as vezes que ocorreram. Trinta e um EAM foram identificados em 12,8% das internações; 11(35,5%) EAM foram detectados sem auxílio dos rastreadores, sendo prurido e diarreia os mais frequentes. Conclusão: a ferramenta de rastreadores mostrou-se útil para a identificação de EAM em crianças hospitalizadas, principalmente se forem utilizados rastreadores com alto rendimento e alta frequência na identificação de eventos. A inclusão dos rastreadores diarreia e prurido pode favorecer a identificação de EAM em pacientes de enfermaria pediátrica.


Subject(s)
Humans , Pediatric Nursing , Child, Hospitalized , Drug Monitoring , Drug-Related Side Effects and Adverse Reactions , Hospitals, Pediatric , Brazil , Medical Records , Cohort Studies , Maternal-Child Health Services , Patient Safety
2.
Washington; Organización Panamericana de la Salud; abr. 7, 2021. 5 p.
Non-conventional in English | LILACS | ID: biblio-1177307

ABSTRACT

En las campañas de vacunación, como en la actual situación de COVID-19, es habitual que los países señalen posibles efectos adversos después de la vacunación. Esto no significa necesariamente que los eventos estén relacionados con la vacunación en sí, pero es necesario investigarlos. También muestra que el sistema de vigilancia funciona y que existen controles efectivos. La Organización Mundial de la Salud (OMS) está en contacto regular con la Agencia Europea de Medicamentos (EMA) y otras autoridades reguladoras del mundo para obtener la información más reciente sobre la seguridad de todas las vacunas para COVID-19.


Subject(s)
Humans , Pneumonia, Viral/immunology , Viral Vaccines/adverse effects , Coronavirus Infections/immunology , Upper Extremity Deep Vein Thrombosis/chemically induced , Pandemics/prevention & control , Betacoronavirus/immunology , Drug Monitoring/adverse effects , Immunization Programs/organization & administration , Europe
3.
Arq. gastroenterol ; 57(4): 507-510, Oct.-Dec. 2020. graf
Article in English | LILACS | ID: biblio-1142339

ABSTRACT

ABSTRACT Therapeutic drug monitoring (TDM) of infliximab (IFX) has been recognized as an important strategy in the management of secondary loss of response to this agent, guiding clinical decision-making in the management of inflammatory bowel diseases (IBD). Although most of the data on the application of TDM for IFX refer to the maintenance phase of treatment, many studies have associated higher drug concentrations, specially in the induction phase, with achievement of important treatment targets, such as clinical remission and mucosal healing. This brief communication aims to summarize the literature on the use of TDM during induction phase of IFX and propose application of a simplified approach which can be useful into clinical practice, aiming better outcomes to IBD patients.


RESUMO A monitorização terapêutica dos níveis séricos (Therapeutic drug monitoring - TDM) de infliximabe (IFX) é uma estratégia reconhecida na tomada de decisão clínica frente a perda de resposta secundária a esta droga no manejo das doenças inflamatórias intestinais (DII). Embora a maioria dos dados sobre a aplicação dessa estratégia para IFX se refira à fase de manutenção do tratamento, muitos estudos associaram concentrações mais altas de IFX, especialmente na fase de indução, com o alcance de importantes alvos de tratamento, como remissão clínica e cicatrização da mucosa. Este artigo visa resumir as evidências da literatura sobre o uso de níveis séricos durante a fase de indução do IFX e propor a aplicação de uma abordagem simplificada que pode ser extremamente útil na prática clínica, visando melhores resultados para os pacientes.


Subject(s)
Humans , Inflammatory Bowel Diseases/drug therapy , Drug Monitoring , Infliximab/therapeutic use , Algorithms , Gastrointestinal Agents/therapeutic use
4.
Rev. chil. pediatr ; 91(5): 828-837, oct. 2020. tab, graf
Article in Spanish | LILACS | ID: biblio-1144283

ABSTRACT

La metodología estadística Bayesiana permite, si se conoce la probabilidad poblacional de que un suceso ocurra, modificar su valor cuando se dispone de nueva información individual. Aunque las metodologías Bayesiana y frecuentista (clásica) tienen idénticos campos de aplicación, la primera se aplica cada vez más en investigación científica y análisis de big data. En la farmacoterapia moderna, la farmacocinética clínica ha sido responsable de la expansión de la monitorización, facilitada por desarrollos técnico-analíticos y matemático-estadísticos. La farmacocinética poblacional ha permitido identificar y cuantificar las características fisiopatológicas y de tratamiento en una población de pacientes determinada, en particular en pediatría y neonatología, y otros grupos vulnerables, explicando la variabilidad farmacocinética interindividual. Asimismo, la estimación Bayesiana resulta importante como herramienta estadística aplicada en programas informáticos de optimización farmacoterapéutica cuando la monitorización farmacológica se basa en la interpretación farmacocinética clínica. Aunque con ventajas y limitaciones, la optimización farmacoterapéutica basada en la estimación Bayesiana es cada vez más usada en la actualidad, siendo el método de referencia. Esto es particularmente conveniente para la práctica clínica de rutina debido al limitado número de muestras requeridas por parte del paciente, y a la flexibilidad en cuanto a los tiempos de muestreo de sangre para cuantificación de fármacos. Así, la aplicación de los principios Bayesianos a la práctica de la farmacocinética clínica resulta en la mejora de la atención farmacoterapéutica.


If one knows the probability of an event occurring in a population, Bayesian statistics allows mo difying its value when there is new individual information available. Although the Bayesian and frequentist (classical) methodologies have identical fields of application, the first one is increasin gly applied in scientific research and big data analysis. In modern pharmacotherapy, clinical phar macokinetics has been used for the expansion of monitoring, facilitated by technical-analytical and mathematical-statistical developments. Population pharmacokinetics has allowed the identification and quantification of pathophysiological and treatment characteristics in a specific patient popu lation, especially in the pediatric and neonatal population and other vulnerable groups, explaining interindividual variability. Likewise, Bayesian estimation is important as a statistical tool applied in pharmacotherapy optimization software when pharmacological monitoring is based on clinical phar macokinetic interpretation. With its advantages and despite its limitations, pharmacotherapeutic op timization based on Bayesian estimation is increasingly used, becoming the reference method today. This characteristic is particularly convenient for routine clinical practice due to the limited number of samples required from the patient and the flexibility it shows regarding blood sampling times for drug quantification. Therefore, the application of Bayesian principles to the practice of clinical phar macokinetics has led to the improvement of pharmacotherapeutic care.


Subject(s)
Humans , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , Pharmacology, Clinical/methods , Research Design , Pharmacokinetics , Data Interpretation, Statistical , Models, Statistical , Bayes Theorem , Pharmacology, Clinical/statistics & numerical data , Drug Monitoring/methods , Drug Monitoring/statistics & numerical data
5.
Rev. epidemiol. controle infecç ; 10(3): 1-14, jul.-set. 2020. ilus
Article in Portuguese | LILACS | ID: biblio-1247345

ABSTRACT

Justificativa e objetivos: A Monitorização Terapêutica de Fármacos (MTF) é uma importante ferramenta na otimização da terapia com vancomicina, utilizada no tratamento de infecções graves causadas por bactérias Gram-positivas. O objetivo deste estudo foi implementar um protocolo de monitoramento terapêutico de vancomicina em um hospital e descrever as características clínicas, laboratoriais e de uso deste medicamento após sua implementação. Métodos: Para o desenvolvimento do protocolo, foram utilizados os consensos internacionais sobre MTF de vancomicina. Os dados dos pacientes adultos foram coletados dos prontuários e das estimativas do software farmacocinético. Resultados: O protocolo de vancomicina foi implementado na instituição hospitalar e disponibilizado ao corpo clínico. Foram avaliados 49 pacientes. A vancomicina foi indicada principalmente para tratar pneumonia 15 (30,6%). Entre os microrganismos identificados, Staphylococcus aureus foi o mais presente ­ 8 (50%), e 9 (56,3%) das culturas eram resistentes à oxacilina. Média de uso de vancomicina foi 10,6 (± 6,6) dias, e dose de ataque foi administrada em 33 (67,3%) dos pacientes. Apresentaram insuficiência renal aguda 5 (11,1%) pacientes. O monitoramento das concentrações mínimas no vale (Cmin) de vancomicina ocorreu em 43 (87,8%) pacientes. Na primeira medição, 16 deles (37,2%) apresentaram Cmin inferiores a 10 mcg/dL, e 11 (25,6%), superiores a 20 mcg/dL, dados considerados fora da faixa terapêutica. Conclusão: A elaboração de um protocolo de MTF para a vancomicina orienta o uso racional e seguro desse antibiótico. Formação continuada em recursos humanos e investimento em softwares farmacocinéticos para ajustes de doses podem contribuir para a otimização da terapia com vancomicina.(AU)


Background and objectives: Therapeutic Drug Monitoring (TDM) is an important tool in optimizing vancomycin therapy, a drug used to treat serious infections caused by gram-positive bacteria. The aim of this study was to implement a protocol for the therapeutic monitoring of vancomycin in hospitals and to describe the clinical, laboratory and use characteristics of this drug after its implementation. Methods: The international consensus on vancomycin TDM was used for protocol development. Patient data were collected from medical records and pharmacokinetic software estimates. Results: The vancomycin protocol was implemented at a hospital and made available to the clinical staff. We evaluated 49 patients. Vancomycin was prescribed mainly to treat pneumonia 15 (30.6%). Among the identified microorganisms, Staphylococcus aureus was the most common with 8 cases (50%), and 9 (56.3%) patients were resistant to oxacillin. The average use of vancomycin was 10.6 (± 6.6) days and the loading dose was administered in 33 (67.3%) patients. A total of 5 (11.1%) patients had acute renal failure. Monitoring of Minimal Concentrations in the vancomycin valley (Cmin) occurred in 43 (87.8%) patients. In the first measurement, 16 of them (37.2%) presented Cmin below 10 mcg/dL and 11 (25.6%) above 20 mcg/dL, data considered outside the therapeutic range. Conclusion: The elaboration of an MTF protocol for vancomycin guides the rational and safe use of this antibiotic. Continued training in human resources and investment in dose-adjusting pharmacokinetic software may contribute to the optimization of vancomycin therapy.(AU)


Justificación y objetivos: La monitorización terapéutica de medicamentos (MTF) es una importante herramienta para optimizar la terapia con vancomicina, utilizada para tratar infecciones graves causadas por bacterias grampositivas. El objetivo de este estudio fue implementar un protocolo de MTF de vancomicina en el hospital y describir las características clínicas, de laboratorio y de uso de vancomicina después de su implementación. Métodos: El consenso internacional sobre vancomicina MTF se utilizó para el desarrollo del protocolo. Los datos de los pacientes adultos se obtuvieron de los registros médicos y las estimaciones del software farmacocinético. Resultados: El protocolo se implementó en el hospital y se puso a disposición al personal clínico. Se evaluaron 49 pacientes. La vancomicina fue indicada para pneumonía 15 (30,6%). Entre los microorganismos identificados, Staphylococcus aureus fue el más presente 8 (50%) y 9 (56,3%) de los cultivos fueron resistentes a oxacilina. El promedio del uso de vancomicina fue de 10,6 (± 6,6) días, y la dosis de ataque se administró en 33 (67,3%) pacientes. La insuficiencia renal aguda se encontró en 5 (11,1%) pacientes. El monitoreo de concentraciones mínimas en el valle de vancomicina (Cmin) ocurrió en 43 (87,8%) pacientes. En la primera medición, 16 de ellos (37,2%) presentaron Cmin por debajo de 10 mcg/dL, y 11 (25,6%), por encima de 20 mcg/dL, datos considerados fuera del rango terapéutico. Conclusión: La elaboración de un protocolo de MTF para vancomicina guía el uso racional y seguro de ese antibiótico. La capacitación continua en recursos humanos y la inversión en softwares farmacocinéticos de ajuste de dosis pueden contribuir a la optimización de la terapia con vancomicina.(AU)


Subject(s)
Humans , Vancomycin , Clinical Protocols , Drug Monitoring , Gram-Positive Bacterial Infections
6.
Rev. Méd. Clín. Condes ; 31(2): 197-203, mar.-abr. 2020. tab
Article in Spanish | LILACS | ID: biblio-1223696

ABSTRACT

INTRODUCCIÓN La fenitoína es usada con mucha frecuencia en nuestro medio, por lo que se requiere hacer estudios de monitorización terapéutica, que contribuya a minimizar los efectos adversos y optimizar la terapia farmacológica. En ese contexto, nuestro objetivo ha sido determinar el índice nivel/dosis de la fenitoína en pacientes epilépticos voluntarios de Mérida. MÉTODOS Se realizó un estudio descriptivo, observacional y por reclutamiento consecutivo concurrente, conformado por 30 pacientes voluntarios con diagnóstico de epilepsia. Las muestras de suero se obtuvieron en niveles mínimos de pacientes que estaban en tratamiento con fenitoína durante 1 mes. Los niveles del fármaco se cuantificaron por el método de Inmunoensayo de enzima donante clonada en el equipo Indiko Thermo Scientific. RESULTADOS El índice nivel/dosis fue de 1,4 y 1,6, la concentración plasmática de 4,8mg/l y 8,0mg/l, la capacidad metabólica de 388,4 y 462,9mg/día, respectivamente en mujeres y hombres. Mientras que el nivel de la concentración plasmática en el estado estacionario fue de 6,5mg/l y 5,5mg/l, la dosis de carga máxima de 237,3mg y de 395,6mg, respectivamente en mujeres y hombres con epilepsia de la ciudad de Mérida. CONCLUSIONES Nuestros resultados sugieren que se debe individualizar la dosis en base al índice nivel/dosis de cada paciente, ya que no se puede extrapolar para todos los pacientes con epilepsia, debido a diversos factores como al fenotipo metabólico y al uso de fármacos inductores e inhibidores enzimáticos.


INTRODUCTION Phenytoin is used very frequently in our environment, so it is necessary to do studies of therapeutic monitoring, which helps to minimize adverse drug reaction and optimize pharmacological therapy. In this context, our objective was to determine the level/dose index of phenytoin in volunteer epileptic patients from Mérida. METHODS A descriptive, observational and consecutive concurrent recruitment study was carried out, consisting of 30 volunteer patients with a diagnosis of epilepsy. The serum samples were obtained in minimum levels from patients who were in treatment with phenytoin for 1 month. The levels of the drug were quantified by the method of donor enzyme immunoassay cloned in the Indiko Thermo Scientific equipment. RESULTS The level/dose index was 1,4 and 1,6, the plasma concentration of 4,8mg/l and 8,0mg/l, the metabolic capacity of 388,4 and 462,9mg/day, respectively in women and men. While the level of plasma concentration at steady state was 6,5mg/l and 5,5mg/l, the maximum loading dose of 237,3mg and 395,6mg, respectively in women and men with epilepsy of the city of Mérida. CONCLUSIONS Our results suggest that the dose should be individualized based on the level/dose index of each patient, since it can not be extrapolated for all patients with epilepsy, due to various factors such as the metabolic phenotype and the use of enzyme-inducing drugs and inhibitors.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Young Adult , Phenytoin/administration & dosage , Epilepsy/drug therapy , Anticonvulsants/administration & dosage , Phenytoin/blood , Phenytoin/pharmacokinetics , Cross-Sectional Studies , Drug Monitoring , Anticonvulsants/blood , Anticonvulsants/pharmacokinetics
7.
Dement. neuropsychol ; 14(1): 24-27, Jan.-Mar. 2020. tab
Article in English | LILACS | ID: biblio-1089820

ABSTRACT

ABSTRACT Dementia is a chronic neurodegenerative disease and Alzheimer's disease (AD) is the most prevalent type. Objective: To describe the drug monitoring of patients enrolled in a Clinical Protocol and Therapeutic Guidelines of Alzheimer's Disease (PCDTDA) in Brazil. Methods: A descriptive study based on interviews conducted in 2017 was performed. Patients diagnosed with Alzheimer's disease (AD) enrolled on the PCDTDA were included. The variables assessed were age, sex, time since diagnosis, clinical parameters of Mini-Mental State Exam (MMSE) and Clinical Dementia Rating (CDR), drug therapy used and AD drug collection. Results: The drug monitoring of 143 patients was evaluated. Observing the requirements of the screening tests for patient enrolment on the PCDTDA, all patients had scores for at least one MMSE and CDR assessment at protocol admission. None of the patients underwent the first reassessment of the effectiveness of AD drug therapy or the semiannual reassessment. Conclusion: Although PCDTDA provides the best evidence of AD treatment, the data showed failures in the monitoring of the effectiveness of AD drug therapy at dispensing.


RESUMO A demência é uma doença crônica e neurodegenerativa, e a doença de Alzheimer (DA) é a mais prevalente. Objetivo: Descrever o monitoramento da farmacoterapia de pacientes inseridos no Protocolo Clínico e Diretrizes Terapêuticas da Doença de Alzheimer (PCDTDA), Brasil. Métodos: Estudo descritivo, conduzido por meio de entrevistas em 2017. Foram incluídos pacientes com diagnóstico da doença de Alzheimer (DA) inseridos no PCDTDA. As variáveis foram idade; sexo; tempo de diagnóstico e farmacoterapia da DA; os parâmetros clínicos Mini-exame do estado mental (MEEM) e Clinical Dementia Rating (CDR); e farmacoterapia em uso. Resultados: O monitoramento de 143 pacientes foi avaliado. Considerando a exigência dos testes de rastreio para a inserção do paciente no PCDTDA, observou-se que todos os pacientes tinham pelo menos um escore no MEEM e no CDR na admissão no protocolo. Nenhum paciente foi submetido à primeira reavaliação da efetividade da farmacoterapia da DA e nem à reavaliação semestral. Conclusão: Apesar do PCDTDA ser a maior evidência do tratamento da DA, dados evidenciam falhas no monitoramento da efetividade da farmacoterapia da DA na dispensação.


Subject(s)
Humans , Safety , Pharmaceutical Preparations/administration & dosage , Clinical Protocols , Drug Monitoring , Dementia , Alzheimer Disease , Patient Safety
8.
Rev. ciênc. farm. básica apl ; 41: [13], 01/01/2020. tab, ilus
Article in English | LILACS | ID: biblio-1128572

ABSTRACT

The therapeutic drug monitoring (TDM) is an important strategy for the effectiveness and safety of long-term pharmacotherapy, such as the use of phenobarbital as an anticonvulsant drug in epilepsy. In this sense, HLPC has been presented as a technique for the measurement of phenobarbital in serum. However, the ideal conditions for carrying out the method must be established for each laboratory reality. An analytical method using HPLC was developed and validated in order to identify and quantify Phenobarbital in blood. The chromatographic conditions were C-18 column (Shimpack XR-ODS 50L x 3.0), acetonitrile-water mobile phase (30:70, v v-1), 0.2 mL min-1 flow and reading wavelength of 210 nm. Linearity was established in the range of 2.5 to 80 µg mL-1, the linear correlation coefficient was 0.9981. The average of the coefficient of variation of the precision was 5.30%. The relative standard error of the accuracy was -2.17% and of the recovery coefficient was 97.83%. In all eleven patients, phenobarbital concentrations were below the therapeutic range. The tested method was selective, linear, precise, accurate and showed good recovery.(AU)


Subject(s)
Humans , Male , Female , Phenobarbital/blood , Drug Monitoring/methods , Anticonvulsants/pharmacokinetics , Phenobarbital/adverse effects , Chromatography, High Pressure Liquid/methods , Drug Combinations , Validation Studies as Topic
9.
Rev. Pesqui. (Univ. Fed. Estado Rio J., Online) ; 12: 468-475, jan.-dez. 2020. ilus, tab
Article in English, Portuguese | LILACS, BDENF | ID: biblio-1087433

ABSTRACT

Objetivo: a avaliação da cultura de segurança do paciente permite aos hospitais identificar e gerir prospectivamente questões relevantes de segurança em suas rotinas de trabalho. Método: estudo quantitativo, transversal e descritivo, ocorrida no ano de 2017 na Unidade de Terapia Intensiva Adulta em um hospital privado, localizado em Niterói/RJ. A população foram os profissionais médicos e equipe de enfermagem, utilizando análise estatística por meio de programa R, com a interface Rcmdr. Resultados: baseados nas respostas às perguntas sobre notificação de eventos aplicada com a Pesquisa de Cultura de Segurança do Paciente a 97 profissionais, com uma taxa de resposta de 85,6%, correspondendo a 83 profissionais. Menos de 45% dos participantes da pesquisa sempre notificam um erro, engano ou falha, que afete ou não o paciente, 59,0% não fizeram nenhuma notificação nos últimos 12 meses antecedentes à pesquisa e não houve diferença significativa na quantidade de notificação que destacasse uma categoria profissional, graduados ou não. Discussão: houve maior adesão à notificação de eventos pelos com maior tempo de hospital e com maior tempo naquela terapia intensiva. Não se encontrou correlação do número de notificações relatadas com o tempo de profissão e com a carga horária de trabalho. Conclusão: no que tange à conscientização de incrementar a adesão à notificação de eventos, a análise realizada contribuiu para a melhoria da segurança do paciente


Objective: ealuating the patient's safety culture allows hospitals to identify and manage relevant safety issues prospectively in their work routines. Method: a quantitative, transversal and descriptive study, carried out in 2017 at the Adult Intensive Care Unit in a private hospital, located in Niterói / RJ. The population were medical professionals and nursing staff, using statistical analysis through program R, with the Rcmdr interface. Results: based on responses to questions about event notification applied with the Patient Safety Culture Survey to 97 professionals, with a response rate of 85.6%, corresponding to 83 professionals. Less than 45% of respondents report an error, deception, or failure, affecting the patient, 59.0% did not report in the last 12 months prior to the survey, and there was no significant difference in the amount of notification that stood out a professional category, graduates or not. Discussion: there was greater adherence to the notification of events by those with longer hospital time and with more time in that intensive therapy. There was no correlation between the number of reports reported with the time of profession and the workload. Conclusion: with regard to the awareness of increasing adherence to event notification, the analysis performed contributed to the improvement of patient safety


Objetivo: la evaluación de la cultura de seguridad del paciente permite a los hospitales identificar y gestionar prospectivamente cuestiones relevantes de seguridad en sus rutinas de trabajo. Método: estudio cuantitativo, transversal y descriptivo, ocurrido en el año 2017 en la Unidad de Terapia Intensiva Adulta en un hospital privado, ubicado en Niterói / RJ. La población fueron los profesionales médicos y equipo de enfermería, utilizando análisis estadístico por medio del programa R, con la interfaz Rcmdr. Resultados: basados en las respuestas a las preguntas sobre notificación de eventos aplicada con la Encuesta de Cultura de Seguridad del Paciente a 97 profesionales, con una tasa de respuesta del 85,6%, correspondiendo a 83 profesionales. En la mayoría de los casos, la mayoría de las personas que sufren de la enfermedad de Alzheimer, una categoría profesional, graduados o no. Discusión: hubo mayor adhesión a la notificación de eventos por los con mayor tiempo de hospital y con mayor tiempo en aquella terapia intensiva. No se encontró correlación del número de notificaciones relatadas con el tiempo de profesión y con la carga horaria de trabajo. Conclusión: en lo que concierne a la concientización de incrementar la adhesión a la notificación de eventos, el análisis realizado contribuyó a la mejora de la seguridad del paciente


Subject(s)
Humans , Drug Monitoring/instrumentation , Patient Safety/statistics & numerical data , Cross-Sectional Studies , Risk Factors , Adverse Drug Reaction Reporting Systems/trends , Risk Assessment , Intensive Care Units
11.
Article in Chinese | WPRIM | ID: wpr-828543

ABSTRACT

OBJECTIVE@#To establish a clinically applicable model of rapid identification of adverse drug reaction program (RiADP) for risk management and decision-making of clinical drug use.@*METHODS@#Based on the theory of disproportion analysis, frequency method and Bayes method, a clinically applicable RiADP model in R language background was established, and the parameters of the model were interpreted by MedDRA coding. Based on the actual monitoring data of FDA, the model was validated by the assessing hepatotoxicity of lopinavir/ritonavir (LPV/r).@*RESULTS@#The established RiADP model included four parameters: standard value of adverse drug reaction signal information, empirical Bayesian geometric mean value, ratio of reporting ratio and number of adverse drug reaction cases. Through the application of R language parameter package "phViD", the model parameters could be output quickly. After being encoded by MedDRA, it was converted into clinical terms to form a clinical interpretation report of adverse drug reactions. In addition, the evaluation results of LPV/r hepatotoxicity by the model were matched with the results reported in latest literature, which also proved the reliability of the model results.@*CONCLUSIONS@#In this study, a rapid identification method of adverse reactions based on post marketing drug monitoring data was established in R language environment, which is capable of sending rapid warning of adverse reactions of target drugs in public health emergencies, and providing intuitive evidence for risk management and decision-making of clinical drugs.


Subject(s)
Databases, Pharmaceutical , Decision Making, Computer-Assisted , Drug Monitoring , Drug-Related Side Effects and Adverse Reactions , HIV Protease Inhibitors , Pharmacology , Humans , Liver , Lopinavir , Toxicity , Models, Statistical , Reproducibility of Results , Software , Reference Standards
12.
Article in Chinese | WPRIM | ID: wpr-828098

ABSTRACT

OBJECTIVE@#To investigate the role of pharmacist-led anticoagulation monitoring service for warfarin anticoagulation therapy in patients during hospitalization.@*METHODS@#We retrospectively analyzed the data of 421 patients receiving warfarin anticoagulation therapy during hospitalization between April, 2016 and December, 2017. Of these patients, 316 received daily pharmacist-led anticoagulation monitoring service including checking the patients' International Normalized Ratio (INR) and other pertinent laboratory test results and reviewing medication changes and the patients' clinical status (monitoring group); the other 105 patients receiving warfarin anticoagulation therapy without pharmaceutical care served as the control group. The data including compliance rate of anticoagulant indicators, incidence and rate of prompt management of INR alert, thrombosis and bleeding events during hospitalization were analyzed among these patients.@*RESULTS@#Compared with the control patients, the patients in the monitoring group showed a significantly higher percentage time within target INR range [(73.20±9.46)% (46.32±17.11)%, < 0.001] and a higher qualified rate of INR before discharge (98.42% 60.95%, < 0.001) as well as a higher proper INR-monitoring frequency (97.15% 66.67%, < 0.001). The patients in the monitoring group showed a significantly lower incidence of INR alert than the control patients (8.23% 20.00%, < 0.001) with also a much higher rate of prompt management (96.15% 33.33%). The two groups had similar incidences of clinical events except that the control group reported a higher incidence of minor bleeding episodes (9.52% 2.53%, =0.005).@*CONCLUSIONS@#Pharmacist-led anticoagulation monitoring service can significantly improve the effectiveness and safety of warfarin anticoagulation therapy for patients during hospitalization.


Subject(s)
Anticoagulants , Drug Monitoring , Hospitalization , Humans , Pharmacists , Retrospective Studies , Warfarin
13.
Rev. méd. Chile ; 147(10): 1273-1282, oct. 2019. tab, graf
Article in Spanish | LILACS | ID: biblio-1058594

ABSTRACT

Background: INR is used to monitor the treatment with vitamin K antagonists. A strategy to reduce waiting times for sampling is to measure INR in a capillary sample using a portable point of care (POC) type coagulometer. Aim: To evaluate the correlation of CoaguChek Pro II™, Xprecia™ and microINR™ with venous INR measured at the clinical laboratory and their ease of use. Materials and Methods: Patients provided capillary and venous blood samples for parallel tests comparing Xprecia™ Stride with CoaguChek Pro II™ and with venous INR, microINR™ with CoaguChek Pro IITM and with venous INR. The devices' ease of use was assessed surveying the sampling staff. Results: The three tested devices had good correlation coefficients with venous INR: CoaguChek Pro IITM 0.953 and 0.962; Xprecia™ of 0.912 and microINR™ of 0.932. The correlation coefficient of Xprecia™ with CoaguChek Pro IITM was 0.937 and microINR™ with CoaguChek Pro IITM was 0.976. Conclusions: CoaguChek Pro IITM, Xprecia™ and microINR™ results had a good correlation coefficient with INR measured at the laboratory. Our results indicate that, in the hands of trained users, POC-type coagulometers are reliable and acceptable for routine use in anticoagulant treatment control.


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Point-of-Care Systems/standards , International Normalized Ratio/instrumentation , Reference Standards , Capillaries , Thromboplastin/therapeutic use , Chile , Reproducibility of Results , Drug Monitoring/instrumentation , Drug Monitoring/standards , International Normalized Ratio/standards , Anticoagulants/therapeutic use
14.
Arq. gastroenterol ; 56(4): 390-393, Oct.-Dec. 2019. tab
Article in English | LILACS | ID: biblio-1055169

ABSTRACT

ABSTRACT BACKGROUND: Drug-induced liver injury is still misunderstood in Brazil due to diagnostic difficulties or lack of reporting incidents. OBJECTIVE: To assess the frequency of adverse events related to the use of medicines in a primary healthcare unit, in a city locate southwestern of the state of Bahia, Brazil. METHODS: Prospective study conducted at the Primary Center for Specialized Health (CEMEA), February at August of 2013 in Vitoria da Conquista, Bahia, Brazil. Interviews were conducted with patients over 18 years old, and their clinical and laboratorial data were collected. The CIOMS scale was used to validate the cases. RESULTS: A total of 149 patients, mainly Afro-Brazilian women, received follow-up. Among these patients, three cases of hepatotoxicity were identified, and the medicines associated to drug-induced liver injuries were: nimesulide, budesonide and valacyclovir. CONCLUSION: Drug-induced liver injury is rare in primary healthcare units. It also allowed estimating the incidence of hepatotoxicity induced by allopathic medicines which are standardized by public healthcare authorities.


RESUMO CONTEXTO: As lesões hepáticas induzidas por drogas (DILI), ainda são mal compreendidas no Brasil devido a dificuldades diagnósticas ou à falta de relatos. OBJETIVO: Avaliar a frequência de eventos adversos relacionados ao uso de medicamentos em uma unidade básica de saúde, em uma cidade do sudoeste baiano. MÉTODOS: Estudo prospectivo realizado no período de fevereiro a agosto de 2013 em Vitória da Conquista, Bahia, Brasil. Entrevistas foram realizadas com pacientes maiores de 18 anos; os dados clínicos e laboratoriais foram coletados. A escala do CIOMS foi usada para avaliar causalidade dos casos. RESULTADOS: Um total de 149 pacientes, principalmente mulheres afro-brasileiras, receberam acompanhamento. Entre esses pacientes, três casos de hepatotoxicidade foram identificados e os medicamentos associados à DILI foram: nimesulida, budesonida e valaciclovir. CONCLUSÃO: DILI é raro em unidades básicas de saúde. Os três casos foram todos reversíveis, sem necessidade de internação hospitalar. Políticas de saúde que fomentam a prática da farmacovigilância são extremamente importantes para a prevenção e detecção de DILI.


Subject(s)
Humans , Male , Female , Adult , Sulfonamides/adverse effects , Drug Monitoring/methods , Budesonide/adverse effects , Chemical and Drug Induced Liver Injury/epidemiology , Valacyclovir/adverse effects , Primary Health Care , Brazil/epidemiology , Prospective Studies , Middle Aged
16.
Rev. chil. infectol ; 36(4): 403-413, ago. 2019. tab
Article in Spanish | LILACS | ID: biblio-1042655

ABSTRACT

Resumen La enfermedad fúngica invasora (EFI) es una entidad que afecta pacientes inmunocomprometidos y críticamente enfermos. En los últimos años, el número de pacientes con riesgo de presentarla viene en aumento, con el consecuente incremento de la formulación de antifúngicos de manera profiláctica, anticipada o empírica. Algunos estudios que evaluaron el uso adecuado de antifúngicos han mostrado que hasta 72% de las formulaciones pueden ser inapropiadas, exponiendo a los pacientes al riesgo de efectos adversos e interacciones medicamentosas, con mayores costos de la atención. Se han recomendado diferentes intervenciones para el control y el uso racional de antimicrobianos, conocidas como "antimicrobial stewardship", las que se pueden aplicar al uso de antifúngicos denominándose "antifungal stewardship"". Se presenta una revisión de la literatura médica sobre el uso apropiado de antifúngicos y el impacto de la implementación de programas de optimización del uso de estos medicamentos en algunos centros.


Invasive fungal disease (IFD) is a condition affecting immunosuppressed and critically ill patients. Recently there has been an increase in the amount of patients at risk for IFD, which implies an increase in the prescription of antifungal agents as prophylactic, pre-emptive or empiric therapy. Some studies evaluating appropriateness of antifungal prescription have shown that inappropriate formulations reach 72%, exposing patients to side effects, pharmacological interactions and rising costs. Some groups have recommended many interventions to control and make a rational use of antimicrobials, into strategies known as "antimicrobial stewardship", these interventions are useful also for antifungal agents and it has been named "antifungal stewardship". Here we present a narrative review of the scientific literature showing published articles about appropriate use of antifungal agents and the experience of some centers after implementing antifungal stewardship programs.


Subject(s)
Humans , Inappropriate Prescribing/prevention & control , Invasive Fungal Infections/drug therapy , Antimicrobial Stewardship/methods , Antifungal Agents/administration & dosage , Antifungal Agents/adverse effects , Immunocompromised Host , Drug Monitoring , Inappropriate Prescribing/statistics & numerical data , Invasive Fungal Infections/diagnosis
17.
Cad. Ibero Am. Direito Sanit. (Impr.) ; 8(2): 31-43, abr.-jun.2019. ilus
Article in Portuguese | LILACS | ID: biblio-1016276

ABSTRACT

Objective: to analyze the contribution of patients in drug surveillance, considering some stages of development of these technologies and the interest of public health. Methodology: a bibliographic and documentary analysis was performed on patients' contributions and mechanisms of social participation. Results: we identified consolidated initiatives and results that support the importance of patients in drug surveillance in various segments. However, participation is limited due to the low scientific literacy and ineffectiveness of some social participation mechanisms. Conclusion: patient representative organizations can contribute more effectively to social participation initiatives in drug surveillance, as reported in international experiences. In addition, it is essential that regulatory agencies seek to improve participation mechanisms and the use of methods to collect social contributions, as well as to systematize patients' experiences. (AU).


Objetivo: analizar la contribución de los pacientes a la vigilancia de medicamentos, considerando algunas etapas del desarrollo de estas tecnologías y el interés de la salud pública. Metodología: se realizó un análisis bibliográfico y documental sobre las contribuciones de los pacientes y los mecanismos de participación social. Resultados: identificamos iniciativas y resultados consolidados que respaldan la importancia de los pacientes en la vigilancia de medicamentos en diversos segmentos. Sin embargo, la participación es limitada debido a la baja alfabetización científica y la ineficacia de algunos mecanismos de participación social. Conclusion: Las organizaciones representativas de pacientes pueden contribuir más eficazmente a las iniciativas de participación social en la vigilancia de drogas, como se informa en experiencias internacionales. Además, es esencial que las agencias reguladoras busquen mejorar los mecanismos de participación y el uso de métodos para recaudar contribuciones sociales, así como para sistematizar las experiencias de los pacientes. (AU).


Objetivo: analisar a contribuição dos pacientes na vigilância de medicamentos, considerando algumas etapas de desenvolvimento dessas tecnologias e o interesse da saúde pública. Metodologia: foi realizada análise bibliográfica e documental sobre as contribuições dos pacientes e os mecanismos de participação social. Resultados: identificou-se iniciativas consolidadas e resultados que sustentam a importância do paciente na vigilância de medicamentos em diversos segmentos. Todavia, a participação é limitada devido ao baixo letramento científico e à inefetividade de alguns mecanismos de participação social. Conclusões: organizações representativas de pacientes podem contribuir mais efetivamente em iniciativas de participação social na vigilância de medicamentos, conforme relatado em experiências internacionais. Também, é fundamental que as agências reguladoras busquem aprimorar os mecanismos de participação e a utilização de métodos que possibilitem coletar as contribuições sociais, bem como a sistematização das experiências dos pacientes. (AU).


Subject(s)
Patient Participation , Product Surveillance, Postmarketing , Drug Monitoring , Pharmacovigilance
18.
Int. j. cardiovasc. sci. (Impr.) ; 32(2): 110-117, mar.-abr. 2019. tab, graf
Article in English | LILACS | ID: biblio-987748

ABSTRACT

Background: Warfarin is an oral anticoagulant involved in important interactions with foods and other drugs. Objectives: To evaluate the occurrence of adverse events reported by warfarin users and their relationship with drug interactions. Methods: This was an open cohort, prospective study conducted in an 18-month period with warfarin users attending public health clinics of the city of Ijuí, Brazil. Data were collected by means of interviews administered at patients' home every month. Patients' responses were confirmed by review of medical records when patients sought medical care. Data were analyzed by descriptive statistics. Potential drug interactions were evaluated in a database and vitamin K consumption was quantified using a validated method. Results: A total of 68 patients were followed-up; 63 completed the study and 5 died in the study period. Mean number of medications taken by the patients was 9.6 ± 4.5, and mean number of interactions involving warfarin was 2.91 ± 1.52. Most potential interactions increased the risk of bleeding, 61 of them severe interactions and 116 moderate interactions. Eighty-seven episodes of bleeding and 4 episodes of thrombosis were reported by a total of 37 and 4 patients, respectively. At the occurrence of these events, 56.5% of warfarin users were also taking omeprazole, 35.9% were taking simvastatin and 25.0% paracetamol. Most patients had a low vitamin K intake. Conclusions: A high frequency of potential interactions between warfarin and other drugs was detected, but a low intake of foods that could possibly affect the effects of warfarin was observed. Based on our results, it seems prudent to follow patients on warfarin therapy for drug-drug interactions, aiming to control adverse effects and to promote a safe and effective therapy


Subject(s)
Humans , Male , Female , Middle Aged , Warfarin/adverse effects , Community Health Services/statistics & numerical data , Drug Interactions , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Vitamin K , Omeprazole/therapeutic use , Statistical Analysis , Prospective Studies , Statistics as Topic , Treatment Outcome , Drug Monitoring , Simvastatin/therapeutic use , Drug Incompatibility , Pharmacovigilance , Acetaminophen
19.
Einstein (Säo Paulo) ; 17(1): eAO4396, 2019. tab
Article in English | LILACS | ID: biblio-984360

ABSTRACT

ABSTRACT Objective Analyze the microbiological effectiveness, based on the pharmacokinetics/pharmacodynamics correlation of vancomycin in pediatric patients, and to propose dose adjustment. Methods This is an observational, cross-sectional study, conducted in a pediatric hospital, over a 1-year period (2016 to 2017). Children of both sexes, aged 2 to 12 years, were included in the study; burn children, and children in renal replacement therapy were excluded. For the pharmacokinetic analysis, two samples of 2mL of whole blood were collected, respecting the 2-hour interval between each withdrawal. Results Ten pediatric patients with median age of 5.5 years and interquartile range (IQR) of 3.2-9.0 years, median weight of 21kg (IQR: 15.5-24.0kg) and median height of 112.5cm (IQR: 95-133cm), were included. Only one child achieved trough concentrations between 10µg/mL and 15µg/mL. Conclusion The empirical use of vancomycin in the children studied did not achieve the therapeutic pharmacokinetic/pharmacodynamic target for minimum inhibitory concentration of 1µg/mL.


RESUMO Objetivo Analisar a efetividade microbiológica considerando a correlação farmacocinética/farmacodinâmica de vancomicina em crianças e propor uma estimativa de ajuste na dose. Métodos Trata-se de um estudo observacional, transversal, realizado em hospital pediátrico, no período de 1 ano (2016 a 2017). Foram incluídas crianças de 2 a 12 anos de ambos os sexos, tendo sido excluídas crianças queimadas ou submetidas à terapia renal substitutiva. Para análise farmacocinética, foram coletadas duas amostras de 2mL de sangue total, respeitando o intervalo de 2 horas entre cada coleta. Resultados Foram incluídos dez pacientes pediátricos com idade de 5,5 anos (mediana) e intervalo interquartil (IQ) de 3,2-9,0 anos, peso de 21kg (mediana; IQ: 15,5-24,0kg) e altura de 112,5cm (mediana; IQ: 95-133cm). Apenas uma criança alcançou concentrações mínimas entre 10µg/mL e 15µg/mL. Conclusão A utilização empírica de vancomicina na população de crianças não alcançou o alvo farmacocinético/farmacodinâmico terapêutico para concentração inibitória mínima de 1μg/mL.


Subject(s)
Humans , Male , Female , Child, Preschool , Child , Vancomycin/pharmacokinetics , Anti-Bacterial Agents/pharmacokinetics , Time Factors , Vancomycin/administration & dosage , Microbial Sensitivity Tests , Cross-Sectional Studies , Drug Monitoring/methods , Dose-Response Relationship, Drug , Anti-Bacterial Agents/administration & dosage
20.
Braz. j. med. biol. res ; 52(4): e8006, 2019. tab, graf
Article in English | LILACS | ID: biblio-1001515

ABSTRACT

The aim of the study was to evaluate the diagnostic accuracy of thromboelastometry for assessing rivaroxaban concentrations. The accuracy of thromboelastometry was compared with the high-performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) method, which is the gold standard for drug plasma monitoring (the reference standard). Forty-six clinically stable patients were treated with 10, 15, or 20 mg of rivaroxaban once daily (OD group) or 15 mg twice a day (BID group) (no particular indication for treatment). Patient samples were collected 2 h after the use of the medication (peak) and 2 h before the next dose (trough). The rivaroxaban plasma concentrations were determined via HPLC-MS/MS, and thromboelastometry was performed using a ROTEM® delta analyzer. There were significant prolongations in clotting time (CT) for the 10, 15, and 20 mg of rivaroxaban treatments in the OD groups. In the 15 mg BID group, the responses at the peak and trough times were similar. At the peak times, there was a positive correlation between the plasma concentration of rivaroxaban and CT (Spearman correlation rho=0.788, P<0.001) and clot formation time (rho=0.784, P<0.001), and a negative correlation for alpha angle (rho=−0.771, P<0.001), amplitude after 5 min (rho=−0.763, P<0.001), and amplitude after 10 min (rho=−0.680, P<0.001). The CT presented higher specificity and sensitivity using the cut-off determined by the receiver characteristics curve. ROTEM has potential as screening tool to measure possible bleeding risk associated with rivaroxaban plasma levels.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Drug Monitoring/methods , Factor Xa Inhibitors/blood , Rivaroxaban/blood , Hemorrhage/prevention & control , Thrombelastography , Blood Coagulation Tests , Chromatography, High Pressure Liquid , Tandem Mass Spectrometry , Factor Xa Inhibitors/administration & dosage , Rivaroxaban/administration & dosage , Data Accuracy
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