RESUMEN
INTRODUCTION: Cardiovascular disease remains a leading cause of morbidity and mortality worldwide, with many individuals presenting with acute ischemic stroke or transient ischemic attack (AIS/TIA) due to underlying vascular risk factors (VRF). While these patients typically undergo routine evaluations for acute treatment, the prevention of these conditions is often underestimated. This study reports the prevalence of non-optimized VRF and estimates their degree of avoidability in a cohort of patients treated in a tertiary care center following AIS/TIA. METHODS: This retrospective study enrolled patients older than 18 years who experienced AIS/TIA over a two-year period. Preventability was defined as the degree to which an acute cerebrovascular event could have been prevented if the VRF had been appropriately treated. Using the variables determined at the onset of AIS or TIA, we developed a 10-point scale to classify the degree of preventability (not preventable [score of 0], low preventability [score of 1-3], and high preventability [score of 4 or higher]). We further defined sub-scores based on the effectiveness of treatment of high blood pressure [HBP] (0-2 points), dyslipidemia [DLP] (0-2 points), atrial fibrillation [AF] (1 point), active smoking [AS] (1 point), obesity (1 point), previous coronary heart disease [CHD] (1 point), and previous AIS/TIA (2 points). Demographic factors, etiologies, and imaging findings were evaluated, tabulated independently, and subsequently correlated with clinical findings extracted from the available patient records. RESULTS: Of the 395 patients (334 with AIS and 61 with TIA), 376 (95.19 %) exhibited some degree of preventability, whereas 19 (4.81 %) presented with a nonpreventable event. In total, 296 (74.94 %) presented a low preventable event, and 80 (20.25 %) presented a high preventable event. Applying the Chi-square test of independence to stroke etiology highlighted cardio-aortic embolism and large artery atherosclerosis as groups with a significantly higher burden of risk factors necessitating intervention, while patients with stroke of other etiologies had more adequate control of VRF. In terms of stroke severity, as determined by the National Institutes of Health Stroke Scale (NIHSS), patients with NIHSS scores >5 were more likely to experience preventable events. According to the ABCD2 score, higher risk scores were significantly associated with a higher preventive factor burden; however, age, sex, vascular territory, and Canadian TIA scores were not related to the prevention of AIS/TIA. CONCLUSIONS: The high percentage of preventable events reflects the need to study other factors that may contribute to unhealthy lifestyles in this population. Potential reasons for poor health include high levels of stress, sleep deprivation, working conditions and an unhealthy diet. Further studies are required to better understand these phenomena.
RESUMEN
BACKGROUND: Adverse drug reactions are a problem in healthcare systems worldwide. Children are more susceptible than adults, especially when exposed to specific drug classes, such as antibiotics. OBJECTIVE: To assess the incidence, causality, severity, and avoidability of antibiotic-associated adverse drug reactions in hospitalized pediatric patients. SETTING: Pediatric ward of a high-complexity public hospital in northeast Brazil. METHODS: A prospective cohort study was conducted over six months, including children aged between 28 days and 12 years, hospitalized for more than 48 h, and receiving antibiotics. Liverpool's causality and avoidability assessment tools were used. Primary outcome measures: Incidence of adverse drug reactions, causality, severity, and avoidability, major antibiotics implicated, risk factors. RESULTS: A total of 183 patients were followed, and 35 suspected adverse drug reactions were recorded overall incidence equal to 14.7%. Most adverse drug reactions were classified as moderate severity (76.7%), probable (57.1%) and defined (28.6%) causality, and unavoidable (66.7%). The affected organs were the gastrointestinal system (74.1%) and skin (25.9%). Major antibiotics implicated were ceftriaxone (40.7%), azithromycin (25.9%), and crystalline penicillin (11.1%). The number of antibiotics prescribed per patient during hospitalization and the length of stay were the risk factors identified. CONCLUSION: Causality and severity assessment indicated that most adverse drug reactions were probable and moderate. Possibly avoidable reactions occurred due to inappropriate prescribing when preventive measures were not implemented. Monitoring the use of antibiotics in children is essential to ensure the safety of these patients.
Asunto(s)
Niño Hospitalizado , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Adulto , Antibacterianos/efectos adversos , Niño , Estudios de Cohortes , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Humanos , Estudios ProspectivosRESUMEN
Resumen Objetivo: Caracterizar las reacciones adversas graves evitables por antivirales presentes en el Sistema Cubano de Farmacovigilancia durante los años 2008 al 2017. Material y métodos: Investigación cuantitativa, observacional y descriptiva; enmarcada dentro de los estudios de farmacovigilancia, con un diseño de serie de casos. El universo conformado por las notificaciones de reacciones adversas graves evitables provocadas estos fármacos. Se utilizaron variables como: reacción adversa identificada, grupo de edad, sexo, fármaco antiviral, frecuencia y causas de evitabilidad. Resultados: Las reacciones adversas evitables graves a los antivirales se comportaron a ritmo irregular que muestra tendencia al incremento. Predominaron en hombres (77.8%) y en adultos (94.4%). Zidovudina (44.4%) y nevirapina (38.9%) muestraron la mayor cantidad de reportes, relacionados con la aparición de anemia y síndrome de Stevens Johnson. Los médicos reportaron el 72.2% de los casos. Las reacciones encontradas se describen como frecuentes. Las interacciones medicamentosas (61.1%) fue la principal causa de evitabilidad. Conclusiones: La caracterización de las reacciones adversas graves evitables a los antivirales permitió identificar que las mismas fueron frecuentes, producidas por antirretrovirales y presentadas hombres adultos; siendo la anemia y síndrome de Stevens Johnson las más frecuentes. Las causas de evitabilidad identificadas con mayor frecuencia responden a errores de la prescripción.
Abstract Object: To characterize the serious adverse reactions avoidable by antivirals present in the Cuban Pharmacovigilance System during the years 2008 to 2017. Materials and methods: Quantitative, observational and descriptive research; framed within the pharmacovigilance studies, with a case series design. The sample conformed by the reports of avoidable serious adverse reactions caused by these drugs. Variables were: identified adverse reaction, age group, sex, antiviral drug, frequency and causes of preventability. Results: Severe avoidable adverse reactions to antivirals were presented at an irregular level that shows a tendency to increase. They predominated in men (77.8%) and in adults (94.4%). Zidovudine (44.4%) and nevirapine (38.9%) showed the highest number of reports, related to the appearance of anemia and Stevens-Johnson syndrome. The doctors reported 72.2% of the cases. The reactions found are described as frequent. Drug interactions (61.1%) was the main cause of preventability. Conclusions: The characterization of the serious adverse reactions avoidable to the antivirals allowed to identify that they were in their majority produced by antiretroviral and occurred mainly in adult men; anemia and Stevens-Johnson syndrome were the most frequent. The causes of preventability identified with greater frequency correspond to errors of the prescription.
Resumo Objetivo: Saracterizar as reações adversas graves evitáveis por antivirais presentes no Sistema Cubano de Farmacovigiláncia durante os anos de 2008 a 2017. Materiais e métodos: Pesquisa quantitativa, observacional e descritiva; enquadrada no ámbito de estudos de farmacovigiláncia, com um desenho de estudos de casos. O universo foi constituido pelos relatórios das notificações de reações adversas graves causadas por esses medicamentos. Foram utilizadas variáveis, tais como: reacjao adversa identificada, grupo etário, sexo, fármaco antiviral, frequência e causas de prevenjao. Resultados: Reações adversas severas preveníveis por antivirais surgem a um ritmo irregular mostrando um aumento crescente. Predominaram em homens (77,8%) e em adultos (94,4%). Zidovudina (44,4%) e nevirapina (38,9%) apresentaram o maior número de relatos, relacionados ao aparecimento de anemia e síndrome de Stevens Johnson. Os médicos relataram 72,2% dos casos. As reações encontradas são descritas como frequentes. As interajoes medicamentosas (61,1%) foram a principal causa da prevenção. Conclusões: A caracterização de reações adversas graves, preveniveis por antivirais permitiram identificar que eram frequentes, produzidos por anti-retrovirais e apresentados em homens adultos; sendo a anemia e a síndrome de Stevens Johnson as mais frequentes. As causas mais frequentemente identificadas de prevenção demonstram erros de prescrição.
Résumé Objectif: Caractériser les effets indésirables graves évitables par les antiviraux présents dans le systéme cubain de pharmacovigilance pendant les années 2008 á 2017. Matériaux et méthodes: Recherche quantitative, observationnelle et descriptive; encadré dans les études de pharmacovigilance, avec une conception de série de cas. L'échantillon était conforme aux rapports d'effets indésirables graves évitables provoqués par ces médicaments. Les variables utilisées étaient réaction indésirable identifiée, groupe d'áge, sexe, médicament antiviral, fréquence et causes de prévention. Résultats: Les réactions indésirables évitables tombes aux antiviraux se sont comportées á un rythme irrégulier qui a tendance á augmenter. Ils prédominaient chez les hommes (77,8%) et chez les adultes (94,4%). La zidovudine (44,4%) et la névirapine (38,9%) présentaient le plus grand nombre de signalements, liés á l'apparition de l'anémie et au syndrome de Stevens-Johnson. Les médecins rapportent 72.2% des cas. Les réactions trouvées sont souvent déclinées. Les interactions médicamenteuses (61,1%) étaient la principale cause évitable. Conclusion: La caractérisation des effets indésirables graves évitables antiviraux a permis d'identifier qu'ils étaient produits principalement par les antirétroviraux et se produisaient principalement chez les hommes adultes; l'anémie et le syndrome de Stevens-Johnson étaient les plus fréquents. Les causes évitables identifiées généralement correspondent á des erreurs de prescription.
RESUMEN
OBJECTIVES: To estimate the proportion of patients with drug-related morbidities (DRMs), DRM preventability, and the cost of illness of the DRMs in Brazil. METHODS: We used the decision-analytic model initially developed by Johnson and Bootman (Drug-related morbidity and mortality. A cost-of-illness model. J Manag Care Pharm 1996;2:39-47), which was adapted to the reality of the present study. A hypothetical cohort of patients in ambulatory care setting was simulated considering the perspective of the Brazilian public health system. Direct costs related to health care were obtained from the national databases, and the probability of occurrence of DRMs was established by a panel of clinical experts. Sensitivity analyses were conducted. RESULTS: An estimated 59% ± 14% of all patients assisted by the health system suffer some DRMs. Given these cases, 53% ± 18% were considered preventable. The average cost of managing a patient with any DRM was US $155. The cost of illness of the DRMs in Brazil would account for nearly US $18 billion (US $9-$27 billion) (best and worst case scenarium) annually. This amount is 5 times higher than what the Ministry of Health spends to guarantee free medicines in Brazil. Hospitalizations and long-term stays in hospital correspond to 75% of this cost. The sensitivity analysis showed that the model is sensitive to variations in these two outcomes. CONCLUSIONS: According to the model, a large proportion of patients experience DRM and the economic impact to solve these problems is substantial for the health system. Considering that more than half of these cases are preventable, it could be possible to achieve an enormous saving of resources through actions that improve the process of medication use.
Asunto(s)
Costo de Enfermedad , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/economía , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Morbilidad , Brasil/epidemiología , Técnicas de Apoyo para la Decisión , Costos de la Atención en Salud , Hospitalización/economía , Humanos , Modelos EconómicosRESUMEN
Abstract This article aims to investigate the morbidities related to medications, their risk factors and causes detected in patients who seek the Hospital Emergency Service of a University in the South of Brazil. Data collection was based on application of a questionnaire to patients of a minimum age of 18 years, that signing the Term of Free and Informed Consent (TFIC), during the period from October 2013 to March 2014, and analysis of electronic record charts. Cases were evaluated by pharmacists and a doctor to define whether it was a case of medication related morbidity (MRM) and to establish its possible causes. Avoidability of MRM was verified based on criteria previously established in the literature. In total 535 patients were interviewed, and the frequency of MRM was 14.6%, Approximately 45% of MRMs were related to safety in the use of medications, and approximately 50% presented user-related questions as the possible cause. Hospitalization was required in 44.8% of MRM cases; 62.7% of cases were considered avoidable. Presence of chronic disease and use of potentially dangerous medication and low therapeutic index were considered independent factors associated with development of MRM, according to statistical analysis.
Resumo O objetivo deste artigo é investigar as morbidades relacionadas a medicamentos (MRM), os fatores e as causas detectados em pacientes que buscam o serviço de emergência de hospital universitário do sul do Brasil. A coleta de dados baseou-se na aplicação de um questionário aos pacientes com idade mínima de 18 anos, durante o período de outubro de 2013 a março de 2014, e na análise do prontuário eletrônico. Os casos foram avaliados para definir se era um caso de MRM e para estabelecer as suas possíveis causas. A evitabilidade da MRM foi verificada com base em critérios previamente estabelecidos na literatura. No total foram entrevistados 535 pacientes e a frequência de MRM foi de 14,6%. Aproximadamente, 45% das MRMs foram relacionadas com a segurança no uso de medicamentos e cerca de 50% apresentou como possível causa questões relacionadas ao usuário. Houve necessidade de internação em 44,8% dos casos de MRM; 62,7% dos casos foram considerados evitáveis. Presença de doença crônica e utilização de medicamentos potencialmente perigosos e de baixo índice terapêutico foram consideradas fatores associados ao desenvolvimento de MRM.
Asunto(s)
Humanos , Masculino , Femenino , Adolescente , Adulto , Anciano , Adulto Joven , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Servicio de Urgencia en Hospital/estadística & datos numéricos , Índice Terapéutico , Farmacéuticos/organización & administración , Médicos/organización & administración , Brasil/epidemiología , Comorbilidad , Enfermedad Crónica , Estudios Transversales , Factores de Riesgo , Hospitalización/estadística & datos numéricos , Persona de Mediana EdadRESUMEN
Early rehospitalization after kidney transplantation (KT) is common and may predict future adverse outcomes. Previous studies using claims data have been limited in identifying preventable rehospitalizations. We assembled a cohort of 753 adults at our institution undergoing KT from January 1, 2003 to December 31, 2007. Two physicians independently reviewed medical records of 237 patients (32%) with early rehospitalization and identified (1) primary reason for and (2) preventability of rehospitalization. Mortality and graft failure were ascertained through linkage to the Scientific Registry of Transplant Recipients. Leading reasons for rehospitalization included surgical complications (15%), rejection (14%), volume shifts (11%) and systemic and surgical wound infections (11% and 2.5%). Reviewer agreement on primary reason (85% of cases) was strong (kappa = 0.78). Only 19 rehospitalizations (8%) met preventability criteria. Using logistic regression, weekend discharge (odds ratio [OR] 1.59, p = 0.01), waitlist time (OR 1.10, p = 0.04) and longer initial length of stay (OR 1.42, p = 0.03) were associated with early rehospitalization. Using Cox regression, early rehospitalization was associated with mortality (hazard ratio [HR] 1.55; p = 0.03) but not graft loss (HR 1.33; p = 0.09). Early rehospitalization has diverse causes and presents challenges as a quality metric after KT. These results should be validated prospectively at multiple centers to identify vulnerable patients and modifiable processes-of-care.
Asunto(s)
Fallo Renal Crónico/terapia , Trasplante de Riñón/efectos adversos , Readmisión del Paciente , Adolescente , Adulto , Estudios de Cohortes , Femenino , Rechazo de Injerto , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Complicaciones Posoperatorias , Pronóstico , Modelos de Riesgos Proporcionales , Sistema de Registros , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Infección de Heridas , Adulto JovenRESUMEN
El presente estudio pretende determinar la frecuencia, evitabilidad y consecuencias de los Eventos Adversos (EA) ocurridos en los servicios de hospitalización basándose en las fichas epidemiológicas e historias clínicas de pacientes que hayan tenido un evento durante este periodo. Como resultados se encontró con mayor frecuencia los Eventos Adversos (EA) son debidos a algún procedimiento (63%): suspensión quirúrgica (38%), seguido de otras complicaciones R/C intervención quirúrgica o procedimiento (13.3%), viéndose mayormente afectada la población masculina (61%), en edades de 10 a 29 años (37%). El servicio donde se presentan más frecuentemente estos eventos es cirugía (52%). Esta problemática produce deterioro físico en un 100% en el paciente, además de aumentar la estancia hospitalaria de 1-2 días (91.7%), siendo el mayor factor causal el tipo de asistencia sanitaria que recibe el paciente. Estos eventos pudieron haber sido evitados en un 74% de los casos. En conclusión el presente estudio mostró que los eventos adversos ocurridos con mayor frecuencia fueron los relacionados con algún procedimiento y/o cuidados, siendo de estos, los más comunes la cancelación de turnos quirúrgicos y quemaduras, erosiones y contusiones (incluyendo fracturas consecuentes) respectivamente. Lo que produjo una prolongación de los días de estancia, lo cual no ocasionó directamente situaciones de gravedad o repercusiones importantes en el estado de salud del paciente; pero la aparición de estos Eventos Adversos (E.A) son completamente prevenibles, puesto que tiene que ver directamente con las prácticas de cuidado impartidas por el personal de salud, que requieren mayor concentración al momento de realizar cualquier procedimiento, si se toman en cuenta las medidas necesarias para garantizar la seguridad del paciente.
This study aims to determine the frequency, preventability and consequences of adverse events (AEs) occurring in hospital services based on epidemiologic and clinical records of patients who have had an event during this period. As a result of this most frequently encountered adverse events (AE) it was found that they were due to procedure (63%)as surgical suspension (38%), followed by other complications R / C surgery or procedure (13.3%). the most affected population are male (61%), aged 10 to 29 years (37%). The service in which these events occur more frequently is surgery (52%). This problem causes physical damage by 100% in the patient, moreover it will increase the hospital stay of 1-2 days (91.7%), it is the largest causing factor the type of health care to the patient. These events could have been avoided in 74% of cases. In conclusion this study showed that adverse events occurred most frequently were related to any procedure and / or care. They were the most common; surgical termination of turns and burns, abrasions and contusions (including resulting fractures) respectively. It produced prolongation of the days of stay, which not directly causes serious situations or significant impact on patient health status, but the occurrence of these adverse events (AEs) are completely preventable, since they are related to the practices of care given by health personnel, who require more concentration when performing any procedure, if one takes into account the measures necessary to ensure patient safety