Mortality and years of life lost related to adverse drug events in Brazil.

OBJECTIVE: To assess regional and national mortality and years of life lost (YLL) related to adverse drug events in Brazil. METHODS: This is an ecological study in which death records from 2009 to 2018 from the Mortality Information System were analyzed. Codes from the International Classification of Diseases 10th revision (ICD-10) that indicated drugs as the cause of death were identified. The number of deaths and the YLL due to adverse drug events were obtained. Crude, age- and gender-specific, and age-adjusted mortality rates and YLL rates per 100,000 inhabitants were formed by year, age group, gender, and Brazilian Federative Unit. Rate ratios were calculated by comparing rates from 2009 to 2018. A joinpoint regression model was applied for temporal analysis. RESULTS: For the selected ICD-10 codes, a total of 95,231 deaths and 2,843,413 YLL were recorded. Mortality rates from adverse drug events increased by a mean of 2.5% per year, and YLL rates increased by 3.7%. Increases in rates were observed in almost all age groups for both genders. Variations in rates were found between Federative Units, with the highest age-adjusted mortality and YLL rates occurring in the Distrito Federal. CONCLUSIONS: The numbers and rates of deaths and YLL increased during the study period, and variations in rates of deaths and YLL were observed between Brazilian Federative Units. Information on multiple causes of death from death certificates can be useful for quantifying adverse drug events and analyzing them geographically, by age and by gender.

Concordance analysis of two databases to search for potential drug interactions in onco-hematologic patients.

INTRODUCTION: Potential drug interactions exert a significant impact on patient safety, especially within intricate onco-hematological treatments, potentially resulting in toxicity or treatment failures. Despite the availability of databases for potential drug interaction investigation, persistent heterogeneity in concordance rates and classifications exists. The additional variability in database agreement poses further complexity, notably in critical contexts like onco-hematology. AIM: To analyze the concordance of two databases for researching potential drug interaction in prescriptions for hematological patients at a University Hospital in the Midwest region of Brazil. METHOD: Cross-sectional study developed in a Brazilian hospital. The search for potential drug interaction was conducted in Micromedex® and UpToDate®. The variables were: the presence of potential drug interaction, severity, mechanism, management, and documentation. Data was analyzed in terms of frequency (absolute and relative), Cohen's kappa, and Fleiss kappa. RESULTS: The presence of potential drug interaction, showed a lack of concordance between the databases (k = -0.115 [95% CI: 0.361-0.532], p = 0.003). Regarding the mechanism, a strong agreement was observed (k = 0.805, p < 0.001 [95% CI: 0.550-0.941]). The management concordance showed a fair agreement, 46.8% (k = 0.22, p < 0.001 [95% CI: 0.099-0.341]). Stratifying the categories, significant concordance was observed in "Adjustment of dose + Monitoring" (k = 0.302, p = 0.018) and "Monitoring" (k = 0.417, p = 0.001), while other categories did not reach statistical significance. CONCLUSION: Our study emphasizes the variability in potential drug interaction research, revealing disparities in severity classification, management recommendations, and documentation practices across databases.

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data.

OBJECTIVE: To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS: Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS: Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS: The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

Genomic epidemiological analysis of Klebsiella pneumoniae from Portuguese hospitals reveals insights into circulating antimicrobial resistance.

Klebsiella pneumoniae (Kp) bacteria are an increasing threat to public health and represent one of the most concerning pathogens involved in life-threatening infections and antimicrobial resistance (AMR). To understand the epidemiology of AMR of Kp in Portugal, we analysed whole genome sequencing, susceptibility testing and other meta data on 509 isolates collected nationwide from 16 hospitals and environmental settings between years 1980 and 2019. Predominant sequence types (STs) included ST15 (n = 161, 32%), ST147 (n = 36, 7%), ST14 (n = 26, 5%) or ST13 (n = 26, 5%), while 31% of isolates belonged to STs with fewer than 10 isolates. AMR testing revealed widespread resistance to aminoglycosides, fluoroquinolones, cephalosporins and carbapenems. The most common carbapenemase gene was blaKPC-3. Whilst the distribution of AMR linked plasmids appears uncorrelated with ST, their frequency has changed over time. Before year 2010, the dominant plasmid group was associated with the extended spectrum beta-lactamase gene blaCTX-M-15, but this group appears to have been displaced by another carrying the blaKPC-3 gene. Co-carriage of blaCTX-M and blaKPC-3 was uncommon. Our results from the largest genomics study of Kp in Portugal highlight the active transmission of strains with AMR genes and provide a baseline set of variants for future resistance monitoring and epidemiological studies.

Risk factors for potentially inappropriate medication use in older adults: a cohort study.

BACKGROUND: Much of the knowledge on the use of potentially inappropriate medications (PIM) in older adults is derived from cross-sectional studies, with little known about the risk factors over time. AIM: Longitudinal analysis was applied to estimate the occurrence and risk factors of PIM use among older adults in a 10-year follow-up. METHOD: Longitudinal study with 418 older adult residents of a capital city of Central-West Brazil. The PIM were classified according to the Beers criteria 2019. The usage rate was calculated at baseline (2008) and at the 10-year follow-up moment (2018). Analysis of predictors (sociodemographic, self-rated health, hospitalization, number of comorbidities, polypharmacy, diabetes, hypertension, hypercholesterolemia and nutritional status) was performed using Generalized Estimating Equation (GEE) models. RESULTS: Mean age at baseline was 70.6 years (SD 7.1) and 76% were women; 221 older adults took part in the follow up. The rate of PIM use was 50.4% at baseline and 57.5% at the 10-year follow-up. Multiple analysis showed that PIM use in the cohort was statistically higher in the older adults with a history of hospitalization (RRadj 1.20; 95% CI 1.01-1.40), with three or more diseases (RRadj 1.41; 95% CI 1.14-1.74), with polypharmacy (RRadj 1.81; 95% CI 1.47-2.24) and with diabetes mellitus (RRadj 1.24; 95% CI 1.05-1.47). CONCLUSION: A high level of potentially inappropriate medication use was observed, reaching 50% of the older adults, with a 7% increase in the prevalence over the 10-year follow-up period. Hospitalization, multimorbidities, polypharmacy and diabetes mellitus were associated with the use of these medications. Interventions for surveillance of the deprescribing process need to be encouraged to avoid potential harm caused by the use of medications.

Hospitalizations and deaths related to adverse drug events worldwide: Systematic review of studies with national coverage.

PURPOSE: Adverse drug events are related to negative outcomes in healthcare, including hospitalization, increased duration of hospital stay and death. The aim of this study was to conduct a systematic review to evaluate hospitalizations and deaths related to adverse drug events worldwide, reported in studies with national coverage. METHODS: The protocol was registered in PROSPERO (CRD42020157008). We performed a systematic search on Medline, Embase, CINAHL, LILACS, and the Cochrane Library (until March 2020) using pre-specified terms. We included published studies that reported data on hospitalizations and/or deaths related to adverse drug events from a national perspective and the use of secondary data as a source of information. Two reviewers independently extracted and synthesized data. The quality of the studies was assessed using an adapted version of the Joanna Briggs Institute critical appraisal checklist for prevalence studies. Narrative summaries of findings were undertaken. RESULTS: Among 59,336 citations, 62 studies were included for data extraction and synthesis. Among these studies, 41 studies included the outcome of hospitalization, 16 included the death outcome, and five included both outcomes. Administrative databases regarding discharges and registries of vital statistics were the most common sources of information. The relative frequency of hospitalizations ranged from 0.03% to 7.3%, and from 9.7 to 383.0/100,000 population, whereas mortality rate ranged from 0.1 to 7.88/100,000 population. CONCLUSION: Our study highlights information about adverse drug events using large administrative databases in a national scenario and provides an overview of databases and methods implemented to detect adverse drug events.

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data

ABSTRACT OBJECTIVE To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

Relação de Trabalho entre Enfermeiros Obstétricos e Doulas na Assistência ao Parto / The work relationship between obstetric nurses and doulas in assistance to childbirth / La relación de trabajo entre enfermeros obstétricos y doulas en la asistencia al parto

Objetivo: O estudo objetiva descrever a relação de Enfermeiros Obstétricos e Doulas na assistência ao trabalho de parto e parto. Métodos: Estudo qualitativo, descritivo e prospectivo, realizado no Centro de Parto Normal localizado em Castanhal, com sete Enfermeiras Obstétricas e três Doulas. Os dados foram coletados entre dezembro/2017 e maio/2018, por meio de entrevista semiestruturada e Análise de Conteúdo de Bardin. Resultados: Emergiram as seguintes categorias: Assistência holística à gestante; A Enfermagem Obstétrica e as Doulas: o desafio no entrecruzar de práticas; Associação de práticas na assistência ao parto normal. Conclusão: Apesar dos relatos evidenciados de conflitos entre as Doulas e as Enfermeiras Obstétricas, é possível identificar uma boa relação na associação de práticas proporcionando benefícios à parturiente. (AU)

Objective: The study aims to describe the relationship between Obstetric Nurses and Doulas in assisting labor and delivery. Methods: A qualitative, descriptive and prospective study, carried out with seven Obstetric Nurses and three Doulas. Data were collected between Dec 2017 to May 2018, through a semi-structured interview and Bardin Content Analysis. Results: The speeches were classified into the following categories: Holistic care for pregnant women; Obstetric Nursing and Doulas: the challenge in the intertwining of practices; Association of practices in assisting normal delivery. Conclusion: Despite the evidences of conflicts between the Doulas and the Obstetric Nurses, it is possible to identify a good relation in the association of practices providing benefits to the parturient. (AU)

Objetivo: El estudio objetivó describir la relación de Enfermeros Obstétricos y Doulas en la asistencia al trabajo de parto y parto. Métodos: Estudio cualitativo, descriptivo y prospectivo, realizado en el Centro de Parto Normal ubicado en Castanhal, con siete Enfermeras Obstétricas y tres Doulas. Los datos fueron recolectados entre diciembre/2017 y mayo/2018, por medio de entrevista semiestructurada y Análisis de Contenido de Bardin. Resultados: Se plantearon las siguientes categorías: Asistencia holística a la gestante; La Enfermería Obstétrica y las Doulas: el desafío en el entrecruzar de prácticas; Asociación de prácticas en la asistencia al parto normal. Conclusion: A pesar de los relatos evidenciados de conflictos entre las Doulas y las Enfermeras Obstétricas, es posible identificar una buena relación en la asociación de prácticas proporcionando beneficios a la parturienta. (AU)

Methylation analysis of Klebsiella pneumoniae from Portuguese hospitals.

Klebsiella pneumoniae is an important nosocomial infectious agent with a high antimicrobial resistance (AMR) burden. The application of long read sequencing technologies is providing insights into bacterial chromosomal and putative extra-chromosomal genetic elements (PEGEs) associated with AMR, but also epigenetic DNA methylation, which is thought to play a role in cleavage of foreign DNA and expression regulation. Here, we apply the PacBio sequencing platform to eight Portuguese hospital isolates, including one carbapenemase producing isolate, to identify methylation motifs. The resulting assembled chromosomes were between 5.2 and 5.5Mbp in length, and twenty-six PEGEs were found. Four of our eight samples carry blaCTX-M-15, a dominant Extended Spectrum Beta Lactamase in Europe. We identified methylation motifs that control Restriction-Modification systems, including GATC of the DNA adenine methylase (Dam), which methylates N6-methyladenine (m6A) across all our K. pneumoniae assemblies. There was a consistent lack of methylation by Dam of the GATC motif downstream of two genes: fosA, a locus associated with low level fosfomycin resistance, and tnpB transposase on IncFIB(K) plasmids. Overall, we have constructed eight high quality reference genomes of K. pneumoniae, with insights into horizontal gene transfer and methylation m6A motifs.

Characterization of adverse drug events identified by trigger in Brazilian pediatric inpatients / Caracterização de eventos adversos a medicamentos identificados por rastreadores em pacientes pediátricos brasileiros hospitalizados

Abstract Objective: To describe the frequency and characteristics of adverse drug events in pediatric inpatients in a Brazilian tertiary teaching hospital. Methods: A cross-sectional study was conducted by retrospective and manual chart review of 240 pediatric admissions to identify adverse drug events using 17 triggers. When triggers were detected in the chart, reviewers investigated the chart in depth to decide whether an event occurred. Consensus about the occurrence of the event was obtained in meeting with a healthcare team. Events were classified by harm category and drugs were classified according to the Anatomical Therapeutic Chemical Classification. Patients who had suffered were compared to those who had not experienced events using the chi-squared test and the Mann-Whitney U test. Results: A total of 62 adverse events were found, and 18.8% of the patients had at least one event. Adverse events rates were 25.83 per 100 admissions, 20.27 per 1000 patient-days, 25.94 per 1000 drugs, and 2.12 per 1000 drug doses. All events found were classified as temporary harm, and cardiovascular drugs were most frequently related to events. Groups of patients with and without event were segregated (p < 0.05) by the length of stay, number of drugs, and drug doses. Conclusion: The use of triggers demonstrated its utility in a pediatric setting by identifying harm. Adverse events rates were found to be higher than those of previous studies, but the harm rate was lower than other studies. This study enables the measurement of adverse events in order to define strategies to mitigate or reduce harm.

Resumo Objetivo: Descrever a frequência e as características dos eventos adversos a medicamentos em pacientes pediátricos internados em um hospital universitário terciário brasileiro. Métodos: Foi realizado um estudo transversal por meio da análise retrospectiva e manual de prontuários de 240 internações pediátricas para identificar eventos adversos a medicamentos utilizando 17 rastreadores. Quando foram identificados rastreadores no prontuário, os analistas investigaram extensivamente o prontuário para decidir a respeito da existência de um evento. O consenso sobre a ocorrência do evento foi obtido em reunião com uma equipe de profissionais da saúde. Os eventos foram classificados por categoria de dano e os medicamentos foram classificados de acordo com a Classificação Anatômica Terapêutico-Química. Os pacientes que sofreram eventos adventos foram comparados aos que não apresentaram eventos adversos, com o teste qui-quadrado e o teste U de Mann-Whitney. Resultados: Verificou-se um total de 62 eventos adversos e 18,8% dos pacientes apresentaram ao menos evento. As taxas de eventos adversos foram de 25,83 por 100 internações, 20,27 por 1.000 pacientes/dia, 25,94 por 1.000 medicamentos e 2,12 por 1.000 doses de medicamentos. Todos os eventos encontrados foram classificados como dano temporário e os medicamentos cardiovasculares foram frequentemente associados aos eventos. Grupos de pacientes com e sem eventos apresentaram diferenças (p < 0,05) em relação ao tempo de internação, número e doses de medicamentos. Conclusão: O uso de rastreadores demonstrou sua utilidade no contexto pediátrico ao identificar danos. As taxas de eventos adversos foram maiores do que as taxas de estudos anteriores, porém a categoria de dano foi menor que em outros estudos. Este estudo possibilita a medição dos eventos adversos a fim de definir estratégias para minimizar ou reduzir os danos.

Genomic Epidemiology of Carbapenemase Producing Klebsiella pneumoniae Strains at a Northern Portuguese Hospital Enables the Detection of a Misidentified Klebsiella variicola KPC-3 Producing Strain.

The evolutionary epidemiology, resistome, virulome and mobilome of thirty-one multidrug resistant Klebsiella pneumoniae clinical isolates from the northern Vila Real region of Portugal were characterized using whole-genome sequencing and bioinformatic analysis. The genomic population structure was dominated by two main sequence types (STs): ST147 (n = 17; 54.8%) and ST15 (n = 6; 19.4%) comprising four distinct genomic clusters. Two main carbapenemase coding genes were detected (blaKPC-3 and blaOXA-48) along with additional extended-spectrum ß-lactamase coding loci (blaCTX-M-15, blaSHV-12, blaSHV-27, and blaSHV-187). Moreover, whole genome sequencing enabled the identification of one Klebsiella variicola KPC-3 producer isolate previously misidentified as K. pneumoniae, which in addition to the blaKPC-3 carbapenemase gene, bore the chromosomal broad spectrum ß-lactamase blaLEN-2 coding gene, oqxAB and fosA resistance loci. The blaKPC-3 genes were located in a Tn4401b transposon (K. variicolan = 1; K. pneumoniaen = 2) and Tn4401d isoform (K. pneumoniaen = 28). Overall, our work describes the first report of a blaKPC-3 producing K. variicola, as well as the detection of this species during infection control measures in surveillance cultures from infected patients. It also highlights the importance of additional control measures to overcome the clonal dissemination of carbapenemase producing clones.

Pharmaceutical intervention in the rational use of intravenous omeprazole.

OBJECTIVE: To describe the pharmaceutical interventions of a vertical clinical pharmacy service to promote the rational use of intravenous omeprazole. METHODS: A prospective and descriptive study carried out at a university hospital in the Midwestern Region of Brazil, from November 2014 to May 2015. The service consisted of the analysis of adequacy of the route of administration of omeprazole in relation to the clinical conditions of the patient, as well as the use of the appropriate diluent. Interventions were recorded in medical records and subsequently evaluated for acceptance. RESULTS: A total of 770 prescriptions were evaluated. Interventions related to diluent replacement were more accepted (p<0.001), and surgeons were the specialty that used the intravenous route inappropriately (p<0.001). CONCLUSION: Although partially accepted, pharmaceutical interventions could contribute to improve patient safety, since they allowed the use of a safer route of administration.

Characterization of adverse drug events identified by trigger in Brazilian pediatric inpatients.

OBJECTIVE: To describe the frequency and characteristics of adverse drug events in pediatric inpatients in a Brazilian tertiary teaching hospital. METHODS: A cross-sectional study was conducted by retrospective and manual chart review of 240 pediatric admissions to identify adverse drug events using 17 triggers. When triggers were detected in the chart, reviewers investigated the chart in depth to decide whether an event occurred. Consensus about the occurrence of the event was obtained in meeting with a healthcare team. Events were classified by harm category and drugs were classified according to the Anatomical Therapeutic Chemical Classification. Patients who had suffered were compared to those who had not experienced events using the chi-squared test and the Mann-Whitney U test. RESULTS: A total of 62 adverse events were found, and 18.8% of the patients had at least one event. Adverse events rates were 25.83 per 100 admissions, 20.27 per 1000 patient-days, 25.94 per 1000 drugs, and 2.12 per 1000 drug doses. All events found were classified as temporary harm, and cardiovascular drugs were most frequently related to events. Groups of patients with and without event were segregated (p<0.05) by the length of stay, number of drugs, and drug doses. CONCLUSION: The use of triggers demonstrated its utility in a pediatric setting by identifying harm. Adverse events rates were found to be higher than those of previous studies, but the harm rate was lower than other studies. This study enables the measurement of adverse events in order to define strategies to mitigate or reduce harm.

Evaluation of a method for drug-related problems identification and classification in hospital setting: applicability and reliability.

Background Prescription evaluation by pharmacists has potential to improve pharmacotherapy management. It requires the use of robust methods to identify drug-related problems (DRP), which are important issues in pharmacotherapy. Objective To evaluate the applicability and reliability of Grupo de Investigação em Cuidados Farmacêuticos (GIGUF) method for prescription analysis, identification and classification of drug-related problems in inpatients prescriptions. Setting Department of Medical Clinic of a tertiary and teaching Brazilian hospital. Method An observational and retrospective study of identification and classification of drug-related problems. GIGUF method was used to evaluate prescriptions of hematological patients hospitalized between August and October 2015. The problems were categorized using GICUF-method classification. Three pharmacists performed inter-rater agreement analysis of the method using Kappa. Differences in prevalence of DRP was calculated by age, sex, pharmacotherapy complexity, length of stay and number of drugs. Main outcome measure (a) frequency and characteristics and (b) inter-rater agreement in identification and classification of the drug-related problems. Results A total of 211 problems were identified and 'inadequate dosing' was the most common problem. There was an association between the occurence of a drug-reklated problem and complexity of pharmacotherapy (p = 0.001) and number of drugs used (p = 0.010). The overall inter-rater agreement was moderate (k = 0.44 IC 95% 0.34-0.55) and the problem 'not suitable drug' (k = 0.55 IC 95% 0.44-0.66) had greater inter-rater agreement. Conclusion The method "Evaluation Drug Use Process" was useful for prescription analysis since it made the identification and classification of DRPs possible. The method demonstrated a moderate inter-rater agreement, and can contribute to pharmacotherapy management by hospital pharmacists.

Pharmaceutical intervention in the rational use of intravenous omeprazole / Intervenção farmacêutica no uso racional de omeprazol intravenoso

ABSTRACT Objective: To describe the pharmaceutical interventions of a vertical clinical pharmacy service to promote the rational use of intravenous omeprazole. Methods: A prospective and descriptive study carried out at a university hospital in the Midwestern Region of Brazil, from November 2014 to May 2015. The service consisted of the analysis of adequacy of the route of administration of omeprazole in relation to the clinical conditions of the patient, as well as the use of the appropriate diluent. Interventions were recorded in medical records and subsequently evaluated for acceptance. Results: A total of 770 prescriptions were evaluated. Interventions related to diluent replacement were more accepted (p<0.001), and surgeons were the specialty that used the intravenous route inappropriately (p<0.001). Conclusion: Although partially accepted, pharmaceutical interventions could contribute to improve patient safety, since they allowed the use of a safer route of administration.

RESUMO Objetivo: Descrever as intervenções farmacêuticas de um serviço farmacêutico clínico vertical, para a promoção do uso racional do omeprazol intravenoso. Métodos: Estudo prospectivo e descritivo realizado em um hospital universitário da região Centro-Oeste do Brasil, no período de novembro de 2014 a maio de 2015. O serviço consistia na análise da adequabilidade da via de administração do omeprazol em relação às condições clínicas do paciente, bem como a utilização do diluente adequado. As intervenções eram registradas em prontuário e, posteriormente, avaliadas quanto à aceitação. Resultados: Foram avaliadas 770 prescrições. As intervenções relacionadas à substituição do diluente foram mais aceitas (p<0,001), e os cirurgiões foram a especialidade que utilizou a via intravenosa de maneira inadequada (p<0,001). Conclusão: Embora parcialmente aceitas, as intervenções farmacêuticas puderam contribuir com a melhoria da segurança dos pacientes, uma vez que permitiram a utilização de uma via de administração mais segura.

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients / A versão em Português-BR do Pediatric Trigger Toolkit é aplicável para mensurar eventos adversos a medicamentos em pacientes pediátricos internados em hospitais brasileiros

Abstract Objective: To describe the process of translation, adaptation, and validation of the Brazilian Portuguese version of the Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital. Methods: The validation process for the research instrument was carried out in five steps: (I) translation from English into Brazilian Portuguese by two independent translators; (II) synthesis of the translated versions; (III) adaptation of the triggers to the Brazilian context using a modified Delphi method carried out in two rounds; (IV) application of the research instrument in the review of 240 hospitalizations during 2014; and (V) back-translation from Brazilian Portuguese to English. Results: The translation step resulted in two versions, which were then synthesized to obtain equivalence within the Brazilian cultural context. The process of adapting the research instrument allowed the inclusion and adaptation of some triggers, as well as the exclusion of others, based on the consensus reached among experts during the Delphi step. The positive predictive value of the research instrument was 13.51%, and the antihistamine trigger presented the highest positive predictive value. Conclusion: The research instrument can be used to track the occurrence of adverse drug events in pediatric patients in Brazilian hospitals. Despite the adjustments made, triggers that were not identified or that had low positive predictive value can suggest the need for additional changes. However, more studies are needed before modifying or removing a trigger.

Resumo Objetivo: Descrever o processo de tradução, adaptação e validação para o português do Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital. Métodos: O processo de validação do instrumento de pesquisa foi realizado em 5 etapas: (I) tradução do inglês para o português por dois tradutores independentes; (II) síntese das versões traduzidas; (III) adaptação dos rastreadores para realidade brasileira por meio do método Delphi modificado, em duas rodadas; (IV) aplicação do instrumento de pesquisa na revisão de 240 internações de 2014; e (V) retrotradução do português para o inglês. Resultados: A etapa de tradução resultou em duas versões traduzidas, que foram sintetizadas de forma a obter equivalência ao contexto cultural brasileiro. O processo de adaptação do instrumento de pesquisa possibilitou a inclusão e adaptação dos rastreadores, bem como a exclusão de rastreadores segundo consenso obtido entre os especialistas na etapa Delphi. O valor preditivo positivo do instrumento de pesquisa foi de 13,51% e o rastreador anti-histamínico foi o que apresentou maior valor preditivo positivo. Conclusão: O instrumento de pesquisa pode ser utilizado para rastrear a ocorrência de eventos adversos a medicamentos em pacientes pediátricos nos hospitais brasileiros. Apesar das adaptações realizadas, rastreadores que não foram identificados ou com baixo valor preditivo positivo podem indicar, ainda, a necessidade de modificações. Entretanto, mais estudos são necessários antes de modificar ou excluir algum rastreador.

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients.

OBJECTIVE: To describe the process of translation, adaptation, and validation of the Brazilian Portuguese version of the Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital. METHODS: The validation process for the research instrument was carried out in five steps: (I) translation from English into Brazilian Portuguese by two independent translators; (II) synthesis of the translated versions; (III) adaptation of the triggers to the Brazilian context using a modified Delphi method carried out in two rounds; (IV) application of the research instrument in the review of 240 hospitalizations during 2014; and (V) back-translation from Brazilian Portuguese to English. RESULTS: The translation step resulted in two versions, which were then synthesized to obtain equivalence within the Brazilian cultural context. The process of adapting the research instrument allowed the inclusion and adaptation of some triggers, as well as the exclusion of others, based on the consensus reached among experts during the Delphi step. The positive predictive value of the research instrument was 13.51%, and the antihistamine trigger presented the highest positive predictive value. CONCLUSION: The research instrument can be used to track the occurrence of adverse drug events in pediatric patients in Brazilian hospitals. Despite the adjustments made, triggers that were not identified or that had low positive predictive value can suggest the need for additional changes. However, more studies are needed before modifying or removing a trigger.

Whole-genome sequencing resolves a polyclonal outbreak by extended-spectrum beta-lactam and carbapenem-resistant Klebsiella pneumoniae in a Portuguese tertiary-care hospital.

Klebsiella pneumoniae has emerged as an important nosocomial pathogen, with whole-genome sequencing (WGS) significantly improving our ability to characterize associated outbreaks. Our study sought to perform a genome-wide analysis of multiclonal K. pneumoniae isolates (n=39; 23 patients) producing extended spectrum beta-lactamases and/or carbapenemases sourced between 2011 and 2016 in a Portuguese tertiary-care hospital. All isolates showed resistance to third-generation cephalosporins and six isolates (five patients) were also carbapenem resistant. Genome-wide-based phylogenetic analysis revealed a topology representing ongoing dissemination of three main sequence-type (ST) clades (ST15, ST147 and ST307) and transmission across different wards, compatible with missing links that can take the form of undetected colonized patients. Two carbapenemase-coding genes were detected: blaKPC-3, located on a Tn4401d transposon, and blaGES-5 on a novel class 3 integron. Additionally, four genes coding for ESBLs (blaBEL-1, blaCTX-M-8, blaCTX-M-15 and blaCTX-M-32) were also detected. ESBL horizontal dissemination across five clades is highlighted by the similar genetic environments of blaCTX-M-15 gene upstream of ISEcp1 on a Tn3-like transposon. Overall, this study provides a high-resolution genome-wide perspective on the epidemiology of ESBL and carbapenemase-producing K. pneumoniae in a healthcare setting while contributing for the adoption of appropriate intervention and prevention strategies.

[Trajectory in narratives: experiences of mental illness and the city of Belo Horizonte]. / Trajetória em narrativas: loucuras e a cidade de Belo Horizonte, Brasil.

The article seeks to understand the relationships established between mentally ill patients cared for in the open community service network and the city of Belo Horizonte, state capital of Minas Gerais. It is understood that the experience of mental illness is capable of generating narratives that seek to give meaning to suffering and help people to negotiate everyday decisions. The biographical method was used for the construction of narratives of life trajectories of the three participants of the study. The biographical narratives revealed diverse experiences associated with mental illness as well as different meanings attributed to this condition. However, interestingly, these stories have a common pattern, often associated with marginal convivialities with the conventions of order, family and work. There is a break with the striking invisibility in asylums, as open services provide the social movement and manipulation of social codes, creating new territorial delimitations and interpretations. However, the need for empirical studies that address themes such as family relations, housing conditions and income of this population is paramount in order to broaden the right to health discussions for the right to housing, work, the right and to a place in the city.

Trajetória em narrativas: loucuras e a cidade de Belo Horizonte, Brasil / Trajectory in narratives: experiences of mental illness and the city of Belo Horizonte

Resumo O artigo busca compreender as relações estabelecidas entre portadores de sofrimento mental assistidos em um serviço aberto e comunitário e a cidade de Belo Horizonte (BH), capital do Estado de Minas Gerais. Compreende-se que a experiência da loucura é capaz de gerar narrativas que buscam atribuir sentido ao sofrimento e auxiliam as pessoas a negociar as decisões cotidianas. O método biográfico foi utilizado para a construção das narrativas de trajetórias de vida dos três participantes do estudo. Cada pessoa atribuiu um sentido diferente à experiência da loucura, contudo, percebe-se a existência de trajetórias e sociabilidades marginais às convenções da ordem, da família e do trabalho. Verifica-se uma ruptura com a invisibilidade marcante nos manicômios, uma vez que os serviços abertos proporcionam a circulação social e a manipulação de códigos sociais que entremeiam os deslocamentos, criando novas territorialidades e codificações. Contudo, evidencia-se a necessidade de estudos empíricos que contemplam temáticas como as relações familiares e as condições de moradia e renda dessa população, para, então, ampliar as discussões do direito à saúde para o direito à moradia, ao trabalho, enfim, o direito e o cabimento na cidade.

Abstract The article seeks to understand the relationships established between mentally ill patients cared for in the open community service network and the city of Belo Horizonte, state capital of Minas Gerais. It is understood that the experience of mental illness is capable of generating narratives that seek to give meaning to suffering and help people to negotiate everyday decisions. The biographical method was used for the construction of narratives of life trajectories of the three participants of the study. The biographical narratives revealed diverse experiences associated with mental illness as well as different meanings attributed to this condition. However, interestingly, these stories have a common pattern, often associated with marginal convivialities with the conventions of order, family and work. There is a break with the striking invisibility in asylums, as open services provide the social movement and manipulation of social codes, creating new territorial delimitations and interpretations. However, the need for empirical studies that address themes such as family relations, housing conditions and income of this population is paramount in order to broaden the right to health discussions for the right to housing, work, the right and to a place in the city.