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1.
Rev Esp Quimioter ; 32(5): 432-439, 2019 Oct.
Artigo em Espanhol | MEDLINE | ID: mdl-31558008

RESUMO

OBJECTIVE: The aim of the study was to describe the type of vaccines administered in the Vaccine Unit at a reference hospital. Calculate the overall and specific reporting rate of adverse reactions. METHODS: Retrospective observational study for the period between November 2014 and November 2017, on patients who developed an adverse drug reaction (ADR) after the administration of a vaccine and who were notified to the Spanish Pharmacovigilance System. The variables analyzed were age, sex, risk group, vaccine class, co-administration and type of ADR. A univariate and bivariate analysis was performed. The global and vaccine specific rate of ADR notification was calculated. RESULTS: A total of 18,123 vaccines were administered, of which 20.7% corresponded to hepatitis B virus vaccine. Fifty-three RAM suspects were reported. In 64.2% of cases only one vaccine was administered. Inactivated vaccines accounted for 88.7% of notifications. The highest number of notifications was generated by the 23 serotypes pneumococcal polysaccharide vaccine. The overall reporting rate was 0.42%. The hexavalent vaccine had the highest reporting rate (2.81%). 49.1% of the ADR were systemic. CONCLUSIONS: The overall reporting rate was low but higher than that of other authors. Proper reporting of possible adverse post-vaccine reactions is essential to contribute to vaccine safety and to increase public confidence in vaccines.


Assuntos
Hospedeiro Imunocomprometido , Farmacovigilância , Vacinas/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Criança , Pré-Escolar , Feminino , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Fotografação , Vacinas Pneumocócicas/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Estudos Retrospectivos , Espanha , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/efeitos adversos , Vacinas/administração & dosagem , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Adulto Jovem
3.
Rev Esp Quimioter ; 32(2): 178-182, 2019 Apr.
Artigo em Espanhol | MEDLINE | ID: mdl-30834736

RESUMO

OBJECTIVE: To describe the clinical-epidemiological characteristics of a series of suspected systemic adverse reactions registered with the 23 serotype pneumococcal polysaccharide vaccine (PNEUMOVAX23®). Calculate the cumulative incidence of the reaction and know if similar and/or compatible cases have been described in the scientific literature or in pharmacovigilance. METHODS: Observational and retrospective study realized between 01/12/2015 and 30/09/2017 in the Vaccines Unit of an autonomic reference hospital. We calculated the cumulative incidence of the adverse reaction for that vaccine. The common pharmacovigilance database (FEDRA) was consulted. RESULTS: Nine systemic adverse reactions were recorded (flushing + bronchospasm + SatO2<95%). The cumulative incidence was 1.036%. The outcome was recovered/resolved for everyone. No similar and/or compatible cases were found. CONCLUSIONS: The reactions described do not appear in the PNEUMOVAX23® data sheet. Epidemiologically, no causal relationship can be established between the symptoms and the variables studied. This study could be the basis for more detailed research that could modify the vaccine data sheet.


Assuntos
Espasmo Brônquico/induzido quimicamente , Espasmo Brônquico/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Rubor/induzido quimicamente , Rubor/epidemiologia , Vacinas Pneumocócicas/efeitos adversos , Adolescente , Adulto , Idoso , Criança , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Farmacovigilância , Estudos Retrospectivos , Espanha/epidemiologia , Adulto Jovem
5.
Rev. calid. asist ; 31(5): 293-299, sept.-oct. 2016. tab
Artigo em Espanhol | IBECS | ID: ibc-155943

RESUMO

Introducción. El aislamiento preventivo del paciente con microorganismos multirresistentes se considera una medida eficaz para evitar situaciones de brote epidémico en el ámbito hospitalario. El objetivo es evaluar el cumplimiento por parte de profesionales sanitarios y familiares de las precauciones de aislamiento de contacto en pacientes colonizados/infectados con microorganismos multirresistentes. Material y métodos. Estudio observacional desde octubre de 2014 a marzo de 2015. Se diseñó una lista de verificación de monitorización con variables de estructura (dotación material), conocimiento de la situación y cumplimiento de las precauciones por pacientes, familias y profesionales. Se realizó análisis univariante y bivariante. Se utilizaron las pruebas no paramétricas U de Mann-Whitney y KruskalWallis. Resultados. Se realizaron 467 monitorizaciones. El carro se encontraba correctamente ubicado en 453 ocasiones (97%). El tensiómetro individual estaba presente en 421 observaciones (90%), mientras que el fonendoscopio y el termómetro no superaban el 44% (43,9% de 205 y 16,5% de 77, respectivamente). El contenedor de residuos y el producto de base alcohólica se observaron bien ubicados en 461 (98,7%) de los casos. El jabón antiséptico para higiene del paciente se registró correctamente colocado en 348 ocasiones (74%). El 84,9% (305) de los pacientes y el 91,4% (234) de los familiares conocían la situación. El cumplimiento en los profesionales de colocación/retirada de bata desechable y guantes se situó próximo al 50% para la entrada a la habitación (49,5% de 56 y 53,0% de 60, respectivamente) y fue del 40% (28) para la salida. La higiene de manos se registró como realizada en 30 ocasiones (26,5%) a la entrada y 25 (35,2%) a la salida. Conclusiones. Existe un importante margen de mejora en el cumplimiento de las precauciones de aislamiento. El incumplimiento actual no puede ser imputado al déficit de materiales, sino a conductas individuales. Urge implementar y evaluar programas de intervención basados en modelos psicosociales, capaces de modificar la actitud y las conductas relacionadas con las precauciones de aislamiento de contacto por microorganismos multirresistentes (AU)


Introduction. Preventive isolation of patients with multidrug-resistant microorganisms is considered an effective measure to prevent outbreaks in hospitals. The objective of this study is to assess compliance by healthcare workers and family of contact isolation precautions in colonised/infected patients with multidrug-resistant microorganisms. Methods. An observational study was conducted from October 2014 to March 2015. A checklist with a structure was designed (equipment trolley), including knowledge of the situation and compliance by the patients, families, and healthcare workers. Univariate and bivariate analyses were performed. Non-parametric tests Mann-Whitney and Kruskal-Wallis were used. Results. Out of the 467 observations made, the equipment trolley was correctly situated in 97% (453) of cases, the sphygmomanometer in 90% (421), the stethoscope 43.9% (205), and thermometer 16.5% (77). A dustbin and the alcoholic solution were observed in over 98.7% (461) of cases. The antiseptic soap for patient hygiene was observed to be correctly placed in 348 (74%) of occasions. The situation was known by 84.9% (305) of patients and 91.4% (234) of families. As regards compliance by professionals with the placement/removal of disposable gowns and gloves was about 50% for entering the room (49.5%, 56 gown and 53.09%, 60 gloves), and 40% (28) for leaving the room by professionals. Hand hygiene compliance was 26.5% (30) for entering and 35.2% (25) when leaving. Conclusions. There is significant room for improvement in the compliance with isolation precautions. Non-compliance to isolation procedures is not due to a deficit of materials, but to individual behaviours. It is important to implement and evaluate programs based on psychosocial intervention models that can change attitudes and behaviours related to contact isolation precautions for multidrug-resistant microorganisms (AU)


Assuntos
Humanos , Infecção Hospitalar/prevenção & controle , Resistência a Múltiplos Medicamentos , Isolamento de Pacientes , Controle de Infecções/normas , Precauções Universais/métodos , Fidelidade a Diretrizes/estatística & dados numéricos
6.
Rev Calid Asist ; 31(5): 293-9, 2016.
Artigo em Espanhol | MEDLINE | ID: mdl-27091365

RESUMO

INTRODUCTION: Preventive isolation of patients with multidrug-resistant microorganisms is considered an effective measure to prevent outbreaks in hospitals. The objective of this study is to assess compliance by healthcare workers and family of contact isolation precautions in colonised/infected patients with multidrug-resistant microorganisms. METHODS: An observational study was conducted from October 2014 to March 2015. A checklist with a structure was designed (equipment trolley), including knowledge of the situation and compliance by the patients, families, and healthcare workers. Univariate and bivariate analyses were performed. Non-parametric tests Mann-Whitney and Kruskal-Wallis were used. RESULTS: Out of the 467 observations made, the equipment trolley was correctly situated in 97% (453) of cases, the sphygmomanometer in 90% (421), the stethoscope 43.9% (205), and thermometer 16.5% (77). A dustbin and the alcoholic solution were observed in over 98.7% (461) of cases. The antiseptic soap for patient hygiene was observed to be correctly placed in 348 (74%) of occasions. The situation was known by 84.9% (305) of patients and 91.4% (234) of families. As regards compliance by professionals with the placement/removal of disposable gowns and gloves was about 50% for entering the room (49.5%, 56 gown and 53.09%, 60 gloves), and 40% (28) for leaving the room by professionals. Hand hygiene compliance was 26.5% (30) for entering and 35.2% (25) when leaving. CONCLUSIONS: There is significant room for improvement in the compliance with isolation precautions. Non-compliance to isolation procedures is not due to a deficit of materials, but to individual behaviours. It is important to implement and evaluate programs based on psychosocial intervention models that can change attitudes and behaviours related to contact isolation precautions for multidrug-resistant microorganisms.


Assuntos
Infecção Hospitalar/prevenção & controle , Higiene das Mãos , Controle de Infecções , Centros de Atenção Terciária , Fidelidade a Diretrizes , Humanos , Isolamento de Pacientes
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