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Background: High-alert medication (HAM) is more predictable to cause significant harm to the patient, even when used as intended. The damage related to the HAM lead not only suffering to the patient, but also raise the additional costs associated with care. Objective: Evaluate the incidence of drug-related adverse events related to the use of high-alert medications. Methods: It was conducted an active search for information through COCHRANE databases, LILACS, SciELO, SCOPUS, PubMed/MEDLINE and WEB OF SCIENCE. The search strategy included the following terms: "Patient safety", "Medication errors" and "Hospital" and "High Alert Medications" or "Dangerous Drugs" in different combinations. Then two reviewers independently conducted a preliminary evaluation of relevant titles, abstracts and finally full-text. Studies quality was evaluated according to PRISMA declaration. Results: The systematic review evaluated seven articles, which showed that only 11 HAM identified in the literature could have serious events. The most frequently cited were warfarin (22.2%) which progressed from deep vein thrombosis to gangrene, suggesting lower initial doses, followed by cyclophosphamide (22.2%) and cyclosporine (22.2%) which presented invasive fungal infection and death. In addition to these, morphine was compared with its active metabolite (M6G), with M6G causing fewer serious clinical events related to nausea and vomiting, reducing the need for concomitant use of antiemetics. Conclusions: The most reported drug classes in the articles included that were related to incidence of drug-related adverse events in use of high-alert medications: morphine, M6G-glucuronide, haloperidol, promethazine, ivabradine, digoxin, warfarin, ximelagatran, cyclophosphamide, cyclosporine, and ATG. The formulate protocols for the use of these medications, with importance placed on evaluating, among the classes, the medication that causes the least harm.
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BACKGROUND: According to the literature, 25% to 50% of antimicrobials prescribed in hospitals are unnecessary or inappropriate, directly impacting antimicrobial resistance. Thus, the present study aimed to evaluate the use of antimicrobials in a university hospital in Northeast Brazil, using days of therapy (DOT) and length of therapy (LOT) indicators in accordance with the latest national and international recommendations for monitoring the use of antimicrobials. METHODS: This is an observational, prospective analytical study conducted in a teaching hospital, with 94 active beds, distributed between the intensive care unit (ICU), the surgical clinic (SUR), the medical clinic (MED), the pneumology/infectology department (PNE/INF) and pediatrics (PED). The duration of the study was from the beginning of January to the end of December 2018. RESULTS: During the study period, a total of 11,634 patient-days were followed up and 50.4% of the patients were found to have received some antimicrobial, with a significant reduction in use of 1% per month throughout the year. Patients were receiving antimicrobial therapy for 376 days in every 1000 days of hospitalization (LOT = 376/1000pd). Overall, the 1st-generation cephalosporins and fluoroquinolones were the most used in respect of the number of prescriptions and the duration of therapy. The calculated global DOT/LOT ratio showed that each patient received an average of 1.5 antimicrobials during the hospital stay. The incidence of antimicrobial resistance, globally, for both methicillin-resistant Staphylococcus aureus (methicillin R), Carbapenem-resistant Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter baumannii (Carbapenem R), was 1 per 1000 patient-days. CONCLUSIONS: The results obtained from the analyses revealed that half of the patients admitted to the hospital who took part in the study were exposed to the use of antimicrobials at some point during their stay. Although moderate, it is noteworthy that there was a decline in the use of antimicrobials throughout the year. The indicators used in this study were found to be very effective for gathering data on the use of antimicrobials, and assessing the results of the initiatives taken as part of the Stewardship program.
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Anti-Infecciosos , Staphylococcus aureus Resistente à Meticilina , Antibacterianos/uso terapêutico , Carbapenêmicos , Criança , Hospitais , Humanos , Estudos ProspectivosRESUMO
AIMS: The aim of this study was to present the needs of hospital pharmacists in pharmacovigilance practices. METHODS: This study has a cross-sectional design and was carried out with hospital pharmacists in Brazil. The sample was obtained by voluntary recruitment. Pharmacists who worked at Brazilian hospitals and were registered in their respective regulatory councils were invited to participate in the present study. A personalized questionnaire was developed by the authors and was electronically filled out by the respondents on the platform 'Google forms'. The questionnaire was nationally available on the digital platform of the Pharmacy Federal Council, the Brazilian Society of Hospital Pharmacy and Health Services, four Pharmacy regional councils and the social network farmacêuticoclínico®. Quantitative variables were analyzed by mean and standard deviation. The qualitative variables were analyzed by means of absolute and relative frequency. Difficulties related to pharmacovigilance activities are presented in an Ishikawa diagram in the Supplemental Material online. RESULTS: Of the 27 federative units of Brazil, we obtained answers from pharmacists located in 85.2% (n = 23) of them. Among the pharmacovigilance practices developed by Brazilian pharmacists, the adverse drug reaction investigation (55.4%) and notification activities (47.0%) were worthy of note. Numerous difficulties were reported by the pharmacists, highlighting the difficulty in monitoring the medication and imputation of causality (27.7%). After categorizing the difficulties reported, it was observed that the category 'people involved' (45.1%) stood out from the others. CONCLUSION: This study pointed out numerous challenges to pharmacovigilance practices involving pharmacists in Brazil. It is believed that the correction of certain difficulties may impact on the better consolidation of pharmacovigilance activities in the country. However, regulatory agencies at all hierarchical levels of pharmacovigilance must work together to make it possible. PLAIN LANGUAGE SUMMARY: Challenges to the consolidation of pharmacovigilance This is a study that seeks to present the needs of Brazilian hospital pharmacists in relation to pharmacovigilance activities. Through online interviews, pharmacists answered a questionnaire, presented the pharmacovigilance activities they develop and expressed their anxieties and difficulties for the development of these activities. With this study, it was concluded that numerous activities of active search, investigation and notification of adverse drug reaction are developed by Brazilian pharmacists. However, each pharmacist performs a different method of pharmacovigilance. In addition, it was observed that among the interviewees there was a perception of insufficient professional training and a shortage of professionals to assist in pharmacovigilance activities. These were the main difficulties reported. Therefore, the search for models or agile solutions to solve problems involving adverse drug reactions seems necessary for a better consolidation of pharmacovigilance services in Brazil.
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Justificativa e Objetivos: Diante da relevância e escassez de estudos realizados na região nordeste do Brasil, este estudo tem o objetivo de avaliar a profilaxia antimicrobiana no perioperatório de cirurgias eletivas realizadas em um hospital de ensino de Sergipe. Métodos: Estudo descritivo a partir da coleta de dados contidas em formulários de vigilância de eventos adversos da instituição, no período de janeiro a dezembro de 2015. As variáveis analisadas foram relacionadas à caracterização dos pacientes, procedimentos cirúrgicos realizados e profilaxia antimicrobiana cirúrgica. Para as variáveis categóricas foi realizada análise por distribuição de frequência e para as variáveis quantitativas, as medidas de tendência central e de dispersão correspondentes no software Epi-Info 7, após atender os preceitos éticos. Resultados: Foram avaliadas 752 fichas de vigilância de eventos adversos e complicações pós-operatórias. A profilaxia antimicrobiana foi utilizada em 78,80% das cirurgias, seguiu à padronização do serviço de controle de infecção quanto a seleção do antibiótico (91,80%), administrada no momento ideal (10,90%) e considerada adequada (escolha do antibiótico, momento da administração e duração da profilaxia) (4,40%). A classe de antibiótico de maior escolha foi a das cefalosporinas (93,60%) e o repique foi realizado em somente 22,20% das cirurgias que tinham indicação. Conclusão: A maior parte do uso da profilaxia antimicrobiana não cumpre as diretrizes recomendadas pelos guidelines nacionais e internacionais. Achado que reforça a necessidade de realizar intervenções que levem a mudanças no processo de trabalho das equipes cirúrgicas e garantam a qualidade da assistência e segurança do paciente.(AU)
Background and Objectives: In view of the relevance and scarcity of studies carried out in the northeastern region of Brazil, this study aims to evaluate the antimicrobial prophylaxis in the perioperative period of elective surgeries performed at a teaching hospital in Sergipe. Methods: Descriptive study, with collection of information contained in forms of surveillance of adverse events of the institution, from January to December 2015. The data were collected and entered by a nursing student in an Epi-Info 7 software data base between November 2015 and February 2016. The variables analyzed were related to the characterization of patients, the surgical procedures performed and the surgical antimicrobial prophylaxis. Categorical variable were analyzed by frequency distribution and for the quantitative variables, the corresponding central tendency and dispersion measures. The study respected the ethical precepts. Results: We evaluated 752 chips for the surveillance of adverse events and post-operative complications. Antimicrobial prophylaxis was used in 78.80% of the surgeries, followed by the standardization of the infection control service for antibiotic selection (91.80%), was administered at the ideal time (10.90%) and considered adequate (antibiotic choice, timing of administration, and duration of prophylaxis) (4.40%). The highest antibiotic class was cephalosporin (93.60%) and the peal was performed in only 22.20% of the surgeries that had been indicated. Conclusion: The majority of antimicrobial prophylaxis of this study does not meet the guidelines recommended by the national and international guidelines. This finding reinforces the need to carry out interventions that lead to changes in the work process of the surgical teams and guarantee the quality of patient care and safety.(AU)
Justificación y Objetivos: Ante la relevancia y escasez de estudios realizados en la región nordeste de Brasil, este estudio tiene el objetivo de evaluar la profilaxis antimicrobiana en el perioperatorio de cirugías electivas realizadas en un hospital de enseñanza de Sergipe. Métodos: Estudio descriptivo, con recolección de informaciones contenidas en formularios de vigilancia de eventos adversos de la institución, del período de enero a diciembre de 2015. Las variables analizadas estuvieron relacionadas con la caracterización de los pacientes, los procedimientos quirúrgicos realizados y la profilaxis antimicrobiana quirúrgica. Para las variables categóricas se realizó análisis por distribución de frecuencia y para las variables cuantitativas, las medidas de tendencia central y de dispersión correspondientes. El estudio respetó los preceptos éticos. Resultados: Fueron evaluadas 752 fichas de vigilancia de eventos adversos y complicaciones postoperatorias. La profilaxis antimicrobiana fue utilizada en el 78,80% de las cirugías, siguió a la estandarización del servicio de control de infección en cuanto a la selección del antibiótico (91,80%), fue administrada en el momento ideal (10,90%), y considerada adecuada (elección del antibiótico, momento de la administración y duración de la profilaxis) (4,40%). La clase de antibiótico de mayor elección fue la de las cefalosporinas (93,60%) y el repique fue realizado en sólo el 22,20% de las cirugías que tenían indicación. Conclusión: La mayor parte de la profilaxis antimicrobiana no cumplió las directrices recomendadas por los guidelines nacionales y internacionales. Hallazgo que refuerza la necesidad de realizar intervenciones que lleven a cambios en el proceso de trabajo de los equipos quirúrgicos y garanticen la calidad de la asistencia y seguridad del paciente.(AU)
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Humanos , Infecção da Ferida Cirúrgica , AntibioticoprofilaxiaRESUMO
OBJECTIVE: to evaluate the conformity of care practices of the nursing team during the administration of drugs through central vascular catheter. METHOD: a descriptive, prospective, observational study conducted in an Intensive Care Unit. The non-probabilistic intentional sample consisted of 3402 observations of drug administrations in patients with central vascular catheters. The previously validated collection instrument was constructed based on the Guideline for Prevention of Intravascular catheter-related infections. Data was collected through direct observations of nursing practices performed by the nursing team. The analysis used analytical, descriptive and inferential statistics (Chi-square test and Fisher's exact test). RESULTS: a total of 3402 procedures of drug administrations were observed. Female nursing technicians performed the highest number of actions. In none of the procedures did the professional perform all necessary actions. 0.2% of drug administrations were preceded by hand hygiene and 1.3% by disinfection of the multidose vial, ampoule or injectors. CONCLUSION: the practice evaluated was classified as undesirable. Failure to achieve the desired conformity was probably due to the low adherence of professionals to the practice of hand hygiene and disinfection of materials, injectors and connectors.
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Infecções Relacionadas a Cateter/prevenção & controle , Cateterismo Venoso Central , Fidelidade a Diretrizes/estatística & dados numéricos , Infusões Intravenosas/enfermagem , Infusões Intravenosas/normas , Segurança do Paciente/normas , Padrões de Prática em Enfermagem , Feminino , Humanos , Masculino , Estudos ProspectivosRESUMO
ABSTRACT Objective: to evaluate the conformity of care practices of the nursing team during the administration of drugs through central vascular catheter. Method: a descriptive, prospective, observational study conducted in an Intensive Care Unit. The non-probabilistic intentional sample consisted of 3402 observations of drug administrations in patients with central vascular catheters. The previously validated collection instrument was constructed based on the Guideline for Prevention of Intravascular catheter-related infections. Data was collected through direct observations of nursing practices performed by the nursing team. The analysis used analytical, descriptive and inferential statistics (Chi-square test and Fisher's exact test). Results: a total of 3402 procedures of drug administrations were observed. Female nursing technicians performed the highest number of actions. In none of the procedures did the professional perform all necessary actions. 0.2% of drug administrations were preceded by hand hygiene and 1.3% by disinfection of the multidose vial, ampoule or injectors. Conclusion: the practice evaluated was classified as undesirable. Failure to achieve the desired conformity was probably due to the low adherence of professionals to the practice of hand hygiene and disinfection of materials, injectors and connectors.
RESUMO Objetivo: avaliar a conformidade da prática assistencial da equipe de enfermagem durante a administração de medicamentos por cateter vascular central. Método: estudo descritivo, prospectivo, observacional, realizado em Unidade de Terapia Intensiva. A amostra não probabilística, do tipo intencional, é constituída de 3402 observações de administrações de medicamentos em pacientes em uso de acesso vascular central. O instrumento de coleta, previamente validado, é construído e alicerçado no Guideline for Prevention of Intravascular cateter-related infections. A coleta se deu a partir da observação direta da prática assistencial realizada pela equipe de enfermagem. A análise utilizou estatística analítica, descritiva e inferencial (Teste de Qui-quadrado e Exato de Fisher). Resultados: foram observadas 3402 ações relacionadas a administrações de medicamentos. O maior número de ações foi realizado por Técnicos de Enfermagem do sexo feminino. Em nenhum dos procedimentos o profissional executou todas as ações necessárias, com 0,2% das administrações de medicamento antecedidas pela higienização das mãos e 1,3% pela desinfecção do frasco multidose, ampola ou injetores. Conclusão: a prática avaliada foi classificada como indesejada. A não obtenção da conformidade almejada deu-se, provavelmente, pela baixa adesão dos profissionais à prática de higienização das mãos e à desinfecção de materiais, injetores e conectores.
RESUMEN Objetivo: evaluar la conformidad de la práctica asistencial del equipo de enfermería durante la administración de medicamentos vía catéter vascular central. Método: se trata de un estudio descriptivo, prospectivo, observacional, realizado en una Unidad de Terapia Intensiva. La muestra no probabilística, de tipo intencional, está constituida de 3402 observaciones de administraciones de medicamentos en pacientes con acceso vascular central. El instrumento de recolección, validado previamente, está construido y fundamentado en la Guía para la Prevención de Infecciones Relacionadas con el Catéter Intravascular. La colecta se llevó a cabo a partir de la observación directa de la práctica asistencial desempeñada por el equipo de enfermería. El análisis utilizó la estadística analítica, descriptiva e inferencial (Distribución de Pearson o Ji-cuadrada y el Test Exacto de Fisher). Resultados: se observaron 3.402 acciones relacionadas con la administración de medicamentos. El número mayor de acciones lo realizaron los Técnicos de Enfermería del sexo femenino. En ninguno de los procedimientos el profesional ejecutó todas las acciones necesarias, con el 0,2% de las administraciones de medicamentos antecedidas por la higienización de las manos y el 1,3%, por la desinfección de frascos multidosis, ampollas o inyectores. Conclusión: la práctica evaluada fue clasificada como indeseada. La no obtención de la conformidad anhelada ocurrió, probablemente, debido a la baja adhesión de los profesionales a la práctica de higienización de las manos y a la desinfección de materiales, inyectores y conectores.
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Humanos , Masculino , Feminino , Infusões Intravenosas/enfermagem , Infusões Intravenosas/normas , Fidelidade a Diretrizes/estatística & dados numéricos , Infecções Relacionadas a Cateter/prevenção & controle , Segurança do Paciente/normas , Cateterismo Venoso Central , Estudos Prospectivos , Padrões de Prática em EnfermagemRESUMO
PURPOSE: The present study aims to identify the risk factors for adverse drug reactions (ADR) in pediatric inpatients. METHODS: A prospective cohort study in one general pediatric ward in a hospital in Northeast Brazil was conducted in two stages: the first stage was conducted between August 17th and November 6th, 2015, and the second one between March 1st and August 25th, 2016. We included children aged 0-14 years 11 months hospitalized with a minimum stay of 48 hours. Observed outcomes were the ADR occurrence and the time until the first ADR observed. In the univariate analysis, the time to the first ADR was compared among groups using a log-rank test. For the multivariate analysis, the Cox regression model was used. RESULTS: A total of 173 children (208 admissions) and 66 ADR classified as "definite" and "probable" were identified. The incidence rate was 3/100 patient days. The gastro-intestinal system disorders were the main ADR observed (28.8%). In addition, 22.7% of the ADR were related to antibacterials for systemic use and 15.2% to general anesthesia. Prior history of ADR of the child [hazard ratio (HR) 2.44; 95% confidence interval (CI) 1.19-5.00], the use of meglumine antimonate (HR 4.98; 95% CI 1.21-20.54), antibacterial for systemic use (HR 2.75; 95% CI 1.08-6.98) and antiepileptic drugs (HR 3.84; 95% CI 1.40-10.56) were identified risk factors for ADR. CONCLUSIONS: We identified as risk factors the prior history of ADR of the child and the use of meglumine antimonate, antibacterial for systemic use and antiepileptic drugs.
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Antibacterianos/efeitos adversos , Anticonvulsivantes/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Meglumina/efeitos adversos , Adolescente , Sistemas de Notificação de Reações Adversas a Medicamentos , Anestesia Geral , Brasil , Criança , Pré-Escolar , Clonazepam/efeitos adversos , Estudos de Coortes , Fibrose Cística/tratamento farmacológico , Dipirona/efeitos adversos , Feminino , Gastroenteropatias/complicações , Gastroenteropatias/tratamento farmacológico , Hospitalização , Hospitais Pediátricos , Humanos , Lactente , Recém-Nascido , Pacientes Internados , Masculino , Omeprazol/efeitos adversos , Pediatria , Projetos Piloto , Modelos de Riscos Proporcionais , Análise de Regressão , Fatores de RiscoRESUMO
BACKGROUND: The main objective of the present systematic review is to identify potential risk factors for adverse drug reactions (ADRs) through prospective cohort studies in pediatric inpatients. METHODS: The data search was done in the following electronic databases PubMed/MEDLINE; Scopus; LILACS and Web of Science from the earliest record until 31 May 2015. Two reviewers independently screened each study and one of them assessed the methodological quality according to the Newcastle-Ottawa scale for cohort studies. The data extraction was conducted according to Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative for cohort studies. RESULTS: The only risk factor observed in all studies was the increase in the number of prescription drugs. However, other factors were identified, such as the increase in the length of stay or the number of low- or high-risk drugs prescribed, use of general anesthesia and oncological diagnosis. The cumulative incidence of ADR was 16.4% (95% confidence interval: 15.6 to 17.2). The main professional responsible for ADR identification was the pharmacist and the dominant category among the ADRs were gastrointestinal disorders. In addition, analgesics, antibacterial agents and corticosteroids were the drug classes commonly associated with ADRs. The methodology used in this study was tried to homogenize the data extracted; however, this was not sufficient to correct the discrepancies so it was not possible to perform a meta-analysis. CONCLUSIONS: The increase in the number of prescription drugs was the main risk factor in this population. However, additional studies are required to identify the risk factors for ADRs in pediatric inpatients.
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Erros de Medicação/estatística & dados numéricos , Reconciliação de Medicamentos , Admissão do Paciente/estatística & dados numéricos , Transferência de Pacientes , Adolescente , Adulto , Idoso , Brasil , Estudos de Casos e Controles , Criança , Pré-Escolar , Feminino , Hospitais de Ensino , Humanos , Lactente , Modelos Logísticos , Masculino , Erros de Medicação/prevenção & controle , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de RiscoRESUMO
OBJETIVO: Determinar os microrganismos mais frequentes, o significado clínico e o perfil de sensibilidade aos antimicrobianos dos agentes isolados nas hemoculturas de um hospital escola. MÉTODOS: Trata-se de um estudo retrospectivo realizado por meio de levantamento das hemoculturas positivas de um hospital universitário no período de 2012 a 2014. RESULTADOS: Das 111 hemoculturas obtidas, os microrganismos mais isolados foram Staphylococcus epidermidis (27,4%), outros Staphylococcus coagulase-negativos (32,7%) e Staphylococcus aureus (13,3%). Aproximadamente metade das hemoculturas representou pseudobacteriemia, e Staphylococcus coagulase-negativo foi o contaminante em 89,1% dos casos. A maioria das cepas de S. aureus apresentou suscetibilidade para oxacilina (66,7%), enquanto as de Staphylococcus coagulase-negativo exibiram resistência. Nenhum Gram-positivo apresentou resistência à vancomicina. Escherichia coli, demais enterobactérias (exceto Klebsiella pneumoniae) e bacilos Gram-negativos não fermentadores apresentaram resistência para ampicilina + sulbactam, gentamicina e cefepime, respectivamente. CONCLUSÃO: Gram-positivos representaram a maior parte das bactérias isoladas, e todos foram sensíveis à vancomicina. O elevado número de contaminantes pôde ser atribuído à antissepsia inadequada na coleta, pois Staphylococcus coagulase-negativo, o contaminante mais frequente, está presente na microbiota da pele.
OBJECTIVE: To determine the most frequent microorganisms, the clinical significance and the susceptibility profile to antimicrobial agents obtained in blood cultures at a teaching hospital. METHODS: This was a retrospective study through the analysis of positive blood cultures at an university hospital in the period 2012 to 2014. RESULTS: Of the 111 blood cultures obtained, the most isolated microorganisms were Staphylococcus epidermidis (27.4%), other coagulase-negative Staphylococcus (32.7%) and Staphylococcus aureus (13.3%). Approximately half of blood cultures represented pseudobacteremia, and coagulasenegative Staphylococcus was the contaminant in 89.1% of cases. Most S. aureus strains showed susceptibility to oxacillin (66.7%), while coagulase-negative Staphylococcus showed resistance. No Gram-positive was resistant to vancomycin. Escherichia coli, other members of the Enterobacteriaceae (except Klebsiella pneumoniae) and Gram-negative bacilli non-fermenters were resistant to ampicillin + sulbactam, gentamicin and cefepime, respectively. CONCLUSION: Gram-positive bacteria accounted for most of the bacteria isolated and all were susceptible to vancomycin. The high number of contaminants can be attributed to inadequate antisepsis in the collection, as coagulase-negative Staphylococcus, the most frequent contaminant, is present in the skin microbiota.