Construção e validação do sistema informatizado de notificação voluntária de incidentes (SINVI): uma tecnologia para vigilância de incidentes relacionados à prestação do cuidado / Construction and validation of the computerized system of voluntary notification of incidents (SINVI): a technology for surveillance of incidents related to provision of care

Introdução: a gestão de risco nos serviços de saúde tem o papel de aplicar, de forma sistemática e contínua, as políticas, os procedimentos, as condutas e os recursos na identificação, análise, avaliação, comunicação e controle de riscos e eventos adversos que afetam a segurança, a saúde humana, a integridade profissional, o meio ambiente e a imagem institucional. A identificação dos eventos adversos que acontecem nos serviços de saúde é de extrema importância para o planejamento de ações de mitigação das falhas durante a assistência à saúde. Os sistemas de notificações voluntárias são o alicerce para um programa de segurança do paciente, ajudando a identificar melhorias no desenvolvimento de uma cultura de segurança, e funcionam como uma estratégia para garantir a qualidade. Objetivos: construir um protótipo de Sistema Informatizado de Notificação Voluntária de Incidentes Informatizado (SINVI); identificar os principais incidentes relacionados à prestação dos cuidados em banco de dados e discuti-los frente à literatura; validar um protótipo de um sistema informatizado de notificação voluntária de incidentes. Método: estudo metodológico desenvolvido em três etapas: identificação dos principais incidentes relacionados à prestação de cuidados; construção do protótipo de um Sistema Informatizado de Notificação Voluntária de Incidentes (SINVI); validação de conteúdo e usabilidade do protótipo do Sistema Informatizado de Notificação Voluntária de Incidentes (SINVI). Para a validação de conteúdo, foram utilizados o Coeficiente de Validação de Conteúdo (CVC), a Taxa de Concordância (TC) e o coeficiente de Kappa. Para a validação de usabilidade, foi utilizado o escore de System Usability Scale (SUS). Este estudo foi aprovado pelo Comitê de Ética em Pesquisa (CEP) com o número do Parecer: 3.674.180. Resultados: foram produzidos três produtos: dois estruturados em forma de artigo e o terceiro, em produto acadêmico. O primeiro identificou os principais eventos adversos notificados no país no período de 2014 a 2018; o segundo produto consiste na construção e validação do protótipo do SINVI e o terceiro é a apresentação do produto acadêmico, a produção técnica do protótipo do software do SINVI, localizado no estrado T1 na categorização da CAPES. Conclusão: os três produtos deste relatório de dissertação contribuem para a segurança do paciente nos serviços de saúde na medida em que fornecem subsídios para a gestão de risco e o núcleo de segurança do paciente na captação de dados agregados das notificações a partir do uso de um Sistema Informatizado de Notificação Voluntária de Incidentes (SINVI)

Introduction: risk management in health services has the role of applying, in a systematic and continuous manner, the policies, procedures, conducts and resources in the identification, analysis, evaluation, communication and control of risks and adverse events that affect safety, human health, professional integrity, the environment and the institutional image. The identification of adverse events that occur in health services is extremely important for the planning of actions to mitigate failures during health care. Voluntary reporting systems are the foundation of a patient safety program, helping to identify improvements in the development of a safety culture, and serve as a strategy to ensure quality. Objectives: build a prototype of a Computerized Voluntary Incident Notification System (SINVI); identify the main care-related incidents in a database and discuss them against the literature; validate a prototype of a computerized voluntary incident reporting system. Method: methodological study developed in three stages: identification of the main care-related incidents; construction of the prototype of a Computerized Voluntary Incident Notification System (SINVI); content and usability validation of the prototype of the Computerized Voluntary Incident Notification System (SINVI). For content validation, the Content Validation Coefficient (CVC), the Concordance Rate (CR), and the Kappa coefficient were used. For usability validation, the System Usability Scale (UHS) score was used. This study was approved by the Research Ethics Committee (REC) with Opinion number: 3.674.180. Results: Three products were produced: two structured as articles and the third as an academic product. The first identified the main adverse events reported in the country from 2014 to 2018; the second product consists of the construction and validation of the SINVI prototype and the third is the presentation of the academic product, the technical production of the SINVI software prototype, located on the T1 platform in the CAPES categorization. Conclusion: the three products of this dissertation report contribute to patient safety in health services in that they provide subsidies for risk management and the patient safety nucleus in capturing aggregate data from the notifications using a Computerized Voluntary Incident Notification System (SINVI)

Farmacovigilancia de vacunas y su aplicación en Chile / Vaccine pharmacovigilance and its application in Chile

La inmunización se encuentra entre las intervenciones en salud pública más exitosas y costo efectivas de todas las épocas, siendo su beneficio tan importante como su seguridad. Las vacunas, como cualquier otro medicamento, pueden generar eventos adversos, los que deben ser monitorizados permanentemente por sistemas de vigilancia. Esta disciplina recibe el nombre de Farmacovigilancia de Vacunas (FVV), encargada de estudiar los Eventos Supuestamente Atribuidos a la Vacunación ó Inmunización (ESAVI). El objetivo de este trabajo es revisar la evolución del sistema de farmacovigilancia de vacunas en Chile. El sistema de FVV chileno se basa en la vigilancia pasiva, y contempla la notificación obligatoria al Instituto de Salud Pública (ISP) de todos los ESAVI detectados, por parte de profesionales de la salud, directores de establecimientos y titulares de registro sanitario, priorizando las notificaciones de ESAVI serios e incluyendo la monitorización de todas las vacunas usadas en el país, tanto las que se encuentran incorporadas al Programa Nacional de Inmunización (PNI), como las que se encuentran fuera de este. El sistema de FVV chileno se caracteriza por un trabajo colaborativo permanente entre el ISP y el PNI, y parte de sus desafíos incluyen generar capacidades y alianzas estratégicas con la academia para la realización de estudios post comercialización sobre seguridad de vacunas. Finalmente, es importante destacar que tanto el marco normativo promulgado el año 2010, como la elaboración de procedimientos, el trabajo permanente con el PNI, y la conformación de un comité de expertos de ESAVI, y las diferentes estrategias de retroalimentación, son medidas implementadas que han contribuido a mejorar la tasa de reporte nacional y el análisis de los casos.

Immunization is among the most successful and cost-effective public health interventions of all times, its benefits being as important as its safety. Vaccines, like any other medicine, can generate adverse events, which must be permanently monitored by surveillance systems. Vaccine Pharmacovigilance (VPV) is the discipline responsible for studying Adverse Events Following Immunization (AEFI). The objective of this article is to review the evolution of the pharmacovigilance system of vaccines in Chile. The Chilean VPV system is based on passive surveillance, and establishes the mandatory reporting of all AEFI detected by healthcare workers, directors of healthcare facilities, and Marketing Authorization holders, to the Public Health Institute of Chile (PHI), prioritizing the reporting of serious ESAVI and including the monitoring of all vaccines used in the country, both those that are incorporated into the National Immunization Program (NIP), and those that are outside of it. The Chilean VPV system is characterized by a permanent collaborative work between the PHI and the NIP, and its challenges include generating capacities and strategic alliances with the academy to carry out post-marketing studies on vaccine safety. Finally, it's important to point out that the regulatory framework promulgated in 2010, as well as the elaboration of procedures, the permanent work with the NIP, the formation of an AEFI expert committee, and the different feedback strategies implemented, have contributed in improving case analysis and the national reporting rate.

Suspected adverse drug reactions reported for Brazilian children: cross-sectional study / Suspeitas de reações adversas a medicamento relatadas em crianças brasileiras: estudo transversal

ABSTRACT Objective: To assess spontaneous reports of suspected adverse drug reactions in children aged 0-12 years from the Brazilian Health Regulatory Agency between 2008 and 2013. Methods: A cross-sectional study on suspected adverse drug reactions reports related to medicines and health products in children was carried out for a six-year period (2008-2013). Year of report, origin of report by Brazilian state, gender, age, suspected drug, adverse reaction description and seriousness were included in the analysis. The data obtained was compared to the number of pediatric beds in health services and to global data from the VigiBase (World Health Organization). Results: A total of 3330 adverse drug reactions were reported in children in Brazil in the investigated period (54% were in boys). About 28% of suspected adverse drug reactions reports involved 0 to 1-year-old children. Almost 40% of reports came from the Southeast region. Approximately 60% were classified as serious events. There was death in 75 cases. Nearly 30% of deaths involved off-label use; 3875 medicines (465 active substances) were considered suspected drugs. Anti-infective (vancomycin, ceftriaxone, oxacillin, and amphotericin), nervous system (metamizole) and alimentary tract and metabolism medicines were more frequent in reports. Conclusions: The distribution of suspected adverse drug reactions reports by sex and age group corresponded to the profile of children hospitalized in Brazil. Data about seriousness and medicines reported may be useful to encourage regulatory actions and improve the safe use of medicines in children.

RESUMO Objetivo: Analisar relatos espontâneos de suspeitas de Reação Adversa a Medicamento (RAM) em crianças de 0 a 12 anos notificadas pela Agência Nacional de Vigilância Sanitária entre 2008 e 2013. Métodos: Um estudo transversal a partir de notificações de suspeitas de RAM relacionadas a medicamentos e produtos para a saúde em crianças foi realizado por um período de seis anos (2008-2013). O ano da notificação, a origem do relato por estado brasileiro, sexo, idade, o medicamento suspeito, a descrição da reação adversa e a gravidade foram incluídos na análise, bem como o número de leitos nos serviços de saúde e dados global da VigiBase. Resultados: Um total de 3330 reações adversas foram relatadas em crianças no Brasil no período investigado (54% em meninos). Cerca de 28% dos relatos de suspeitas de RAM envolveram crianças de 0 a 1 ano de idade. Quase 40% dos relatos vieram da região Sudeste. Aproximadamente 60% foram classificados como eventos graves. Houve ocorrência de morte em 75 casos. Quase 30% das mortes envolveram o uso off-label dos medicamentos. Um total de 3875 medicamentos (465 substâncias ativas) foram considerados fármacos suspeitos. Medicamentos anti-infecciosos (vancomicina, ceftriaxona, oxacilina e anfotericina), com ação no sistema nervoso (dipirona) e no trato digestivo foram os mais frequentemente notificados. Conclusões: As notificações de suspeitas de RAM por sexo e faixa etária corresponderam ao perfil de crianças hospitalizadas no Brasil. Os dados sobre gravidade e medicamentos relatados podem ser úteis para encorajar ações reguladoras e melhorar o uso seguro de medicamentos em crianças.

Seguridad en vacunas: descripción de los eventos adversos notificados al sistema de vigilancia en Chile, 2014 a 2016 / Vaccine safety: description of the adverse events reported to the surveillance system in Chile, 2014 to 2016

Resumen Introducción: Los sistemas de vigilancia pasiva de los eventos supuestamente atribuidos a vacunación o inmu nización (ESAVI) permiten monitorizar efectos adversos (EA) conocidos y pesquisar EA infrecuentes. El objetivo de este estudio fue describir los ESAVI notificados en Chile entre los años 2014 y 2016. Material y Método: Estudio de vigilancia epidemiológica. Se realizó un análisis general y un sub-análisis para vacuna pentavalente. Se calculó la tasa de reporte (TR) global de ESAVI cada 100.000 dosis de vacunas, la TR de ESAVI considerados de interés y el odds ratio de reporte (ROR) de apneas para pentavalente. Resultados: El total de ESAVI notificados fue de 2.552 con una TR global de 9,13. Un 13,4% de los ESAVI fueron serios. La TR de eventos de interés fue en general menor a las tasas de referencia. La vacuna con mayor TR (44,3) fue pentavalente, con un ROR de apnea versus otras vacunas de 10,5 (IC 95% 3,77-29,47). Discusión: Este estudio entrega una visión general de los ESAVI notificados en Chile. La TR global fue similar a otras reportadas, pero las de eventos de interés fueron menores a las referencias internacionales. Se muestra una posible asociación entre apneas y vacuna pentavalente.

Background: Passive surveillance systems for adverse events following immunization (AEFI) allow the monitoring of known adverse effects (AE) and the investigation of infrequent AE. Aim: To describe the AEFI notified in Chile between 2014 and 2016. Methodology: This was a study of epidemiological surveillance. A general analysis of AEFI and sub-analysis for pentavalent vaccine was carried out. It was calculated the global reporting rate of AEFI every 100,000 doses of vaccines, the reporting rate of AEFI considered of interest and the odds ratio of reporting (ROR) of apneas for pentavalent. Results: The total AEFI reported was 2,552 with a global reporting rate of 9,13. 13.4% of AEFI were serious. The vaccine reporting rate of events of interest was generally lower than the reference rates. The vaccine with the highest reporting rate (44.3) was pentavalent, with an ROR of apnea versus other vaccines of 10.5 (95% CI 3.77-29.47). Discussion: This study provides an overview of the AEFI notified in Chile. The global reporting rate was similar to other studies, but those of events of interest were lower than international references. A possible association between apnea and pentavalent vaccine is shown.

Reações adversas a medicamentos no sistema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo / Adverse drug reactions reported to the Brazilian pharmacovigilance system from 2008 to 2013: descriptive study / Reacciones adversas a medicamentos en el sistema de farmacovigilancia de Brasil, de 2008 a 2013: estudio descriptivo

Resumo: Analisam-se as suspeitas de reações adversas a medicamentos notificadas no sistema de farmacovigilância do Brasil (Notivisa-medicamento) entre 2008 e 2013. Trata-se de estudo descritivo cujas unidades de análises da base de dados foram as notificações e os pares medicamento-reação adversa. Foi identificado um total de 26.554 notificações, o que produziu uma taxa de notificação de 22,8 milhões de habitantes/ano. As notificações referentes ao sexo feminino (60,5%) prevaleceram, assim como a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de reações adversas a medicamentos ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 registros de pares de medicamento-reação adversa, em que prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). Os medicamentos mais frequentes nas reações adversas a medicamentos graves pertenceram aos grupos L - agentes neoplásicos e imunomodulares (32,1%) e J - anti-infeciosos gerais para uso sistêmico (27%), ao passo que o sistema-órgão-classe mais afetado foi o relacionado a afecções da pele e distúrbios afins (23,7%). O Notivisa-medicamento é relevante recurso para a produção de sinais de alertas e hipóteses sobre a segurança de medicamentos comercializados no Brasil. No entanto, a taxa de notificação por milhão de habitantes/ano mostrou-se muito inferior àquela descrita por países de média e alta renda.

Abstract: The study aimed to analyze suspected adverse drug reactions reported to Brazil's pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identified, for a reporting rate of 22.8/million inhabitants/year. Reports in female patients prevailed (60.5%), as did white color/race (58.1%). Age ranged from 0 to 112 years (median = 46 years). Nearly one-third (32.5%) of suspected adverse drug reactions occurred in vulnerable populations (elderly and children). A total of 54,288 drug- adverse reactions pairs were analyzed, with a prevalence of severe adverse drug reactions (59.2%), featuring those that resulted in clinically important effects (83.1%). The most frequent drugs in severe adverse drug reactions belonged to groups L, antineoplastic and immunomodulating agents (32.1%), and J, general anti-infectious agents for systemic use (27%), while the most affected system-organ-class was conditions of the skin and related disorders (23.7%). Notivisa-medicamento is an important resource for producing warning signs and hypotheses on the safety of drugs marketed in Brazil. However, the reporting rate per million inhabitants/year was far lower than that described in middle and high-income countries.

Resumen: El objetivo de este estudio es analizar las sospechas de reacciones adversas a medicamentos, notificadas en el sistema de farmacovigilancia de Brasil (Notivisa-medicamento), entre 2008 y 2013. Se trata de un estudio descriptivo cuyas unidades de análisis en la base de datos fueron las notificaciones y los pares medicamento-reacción adversa. Se identificaron un total de 26.554 notificaciones, generando una tasa de notificación de 22,8/ millones de habitantes/año. Las notificaciones referentes al sexo femenino (60,5%) prevalecieron, así como, la raza/color blanco (58,1%). La edad varió de 0 a 112 años (mediana = 46 años). Casi 1/3 (32,5%) de las sospechas de reacciones adversas a medicamentos ocurrieron en poblaciones vulnerables (ancianos y niños). Se evaluaron 54.288 registros de pares de medicamento-reacción adversa, donde prevalecieron las reacciones adversas graves (59,2%), destacando las que resultaron en un efecto clínicamente importante (83,1%). Los medicamentos más frecuentes en las reacciones adversas a medicamentos graves pertenecieron a los grupos L - agentes neoplásicos e inmunomoduladores (32,1%) y J - antiinfecciosos generales para uso sistémico (27%), mientras que el sistema-órgano-clase más afectado fue afecciones de la piel y disturbios afines (23,7%). El Notivisa-medicamento es una herramienta relevante para la producción de señales de alerta e hipótesis sobre la seguridad de medicamentos comercializados en Brasil. No obstante, la tasa de notificación por millón de habitantes/año se mostró muy inferior a la que está descrita en países de media y alta renta.

Análise da preferência digital de idade no sistema de farmacovigilância do Brasil, 2008-2013 / Analysis of the digital preference for age in the pharmacovigilance system in Brazil, 2008-2013

Resumo Analisar a preferência digital na variável "idade" da base de dados de casos de eventos adversos a medicamentos notificados entre 2008 e 2013 no sistema de farmacovigilância do Brasil. A base de dados foi analisada em três etapas: 1) exploração inicial; 2) padronização de variáveis; e 3) manejo dos registros repetidos. A preferência digital da variável "idade", segundo sexo e regiões agrupadas do país, foi determinada usando os métodos de Whipple e Myers e medida, também, pelo teste de aderência baseado na estatística χ2 ao nível de 5% de significância.Predominou a população feminina (60,3%), perfazendo uma razão feminino/masculino de 1,5:1 e com maioria feminina em oito das 12 faixas etárias estudadas.Ao longo do período analisado não foi observado qualquer preferência de dígito terminal na variável "idade". As idades registradas nas notificações parecem não demonstrar imprecisão e, por conseguinte, esta informação pode ser interpretada como de qualidade não duvidosa. Tais resultados apontam para um bom desempenho na coleta de dados e informações relacionados à variável "idade" do sistema de farmacovigilância do Brasil.

Abstract The scope of this article is to analyze the digital preference for the "age" variable in the database of cases of adverse drug events reported between 2008 and 2013 in the pharmacovigilance system in Brazil. The database was analyzed in three stages: 1) Initial exploration; 2) standardization of variables; and 3) duplicate records management. The digital preference for the "age" variable according to sex and grouped regions of the country, was determined using the Whipple and Myers methods and also measured by the adhesion test based on statistical χ2 at 5% significance level. The female population was predominant (60.3%), with a female/male ratio of 1.5:1 and a female majority in 8 of the 12 age groups. Throughout the period under analysis, no preference for a terminal digit was observed in the "age" variable. The ages that were registered in the database appear not to reveal any imprecision and, therefore, this information cannot be interpreted as unreliable. These results point to a good performance in collecting data and information related to the "age" variable of the Brazil's pharmacovigilance system.

Impacto clínico de un sistema de farmacovigilancia activa realizado por un farmacéutico en el reporte y subnotificación de reacciones adversas a medicamentos / Assessment of an active pharmacovigilance system carried out by a pharmacist

Background: Despite the importance of notifying and preventing adverse drug reactions (ADRs), they are under reported and their consequences are not adequately evaluated. Aim: To assess the impact of a pharmacovigilance system carried out by a pharmacist. Material and Methods: In an internal medicine service, the spontaneous report of ADRs was compared blindly with an active pharmacovigilance system in which a pharmacist detected, monitored and prevented ADRs. Results: A total of 1,196 patients was included. Of these 604 were hospitalized in intervened wards, where 50 suspected ADRs in 47 patients were reported. In non-intervened wards, only three ADRs were spontaneously reported. Therefore, the pharmacovigilance system significantly improved the detection and report of ADRs with a risk ratio of 15.4 (95% confidence intervals 4.8-49.1). Sixty six percent of ADRs were classified as severe. Antimicrobials were the main group of medications causing ADRs in 44% of reports. Forty three percent of ADRs were preventable and prolonged hospital stay by a mean of eight days. Conclusions: An active pharmacovigilance system carried out by pharmacists improves the detection of ADRs and promotes its prevention.

Causes for the underreporting of adverse drug events by health professionals: a systematic review / Causas de subnotificação de eventos adversos a medicamentos por profissionais da saúde: revisão sistemática / Causas del subregistro de los eventos adversos de medicamentos por los profesionales de la salud: revisión sistemática

Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.
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Objetivo: Identificar as causas de subnotificação de Reação Adversa a Medicamento (RAM) por profissionais da saúde. Método: Revisão sistemática realizada nas bases de dados LILACS, PAHO, SciELO, EMBASE e PubMed, cujo período de abrangência foi de 1992 a 2012. Foram utilizados descritores para buscar os artigos. As causas de subnotificação de RAM identificadas foram analisadas de acordo com a classificação de Inman. Resultados: Identificaram-se 149 artigos, dos quais 29 foram considerados elegíveis. A maioria dos estudos foi conduzida em hospitais (24/29), para médicos (22/29) e farmacêuticos (10/29). As principais causas relacionadas à subnotificação observadas foram: a ignorância (24/29), a insegurança (24/29) e a indiferença (23/29). Conclusão: Os dados evidenciam o oitavo pecado da subnotificação, que é a falta de formação em farmacovigilância. Assim, a educação permanente pode aumentar a adesão dos profissionais ao serviço e melhorar o conhecimento e a comunicação dos riscos associados ao uso de medicamentos.
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Objetivo: Identificar las causas de la subnotificación de la Reacción Adversa a Medicamento (RAM) por profesionales de la salud. Método: Revisión sistemática realizada en las bases de datos LILACS, PAHO, SciELO, EMBASE y PubMed, cuyo período de revisión fue de 1992 a 2012. Se utilizaron descriptores para buscar los artículos. Las causas de subnotificación identificadas fueron analizadas de acuerdo con la clasificación de Inman. Resultados: Se identificaron 149 artículos, de los cuales 29 fueron seleccionados. La mayoría de los estudios fueron realizados en hospitales (24/29) para médicos (22/29) y farmacéuticos (10/29). Las principales causas relacionadas a la subnotificación observadas fueron: la ignorancia (24/29), la inseguridad (24/29) y la indiferencia (23/29). Conclusión: Los datos evidencian el octavo pecado de la subnotificación, que es la falta de formación en farmacovigilancia. Por lo tanto, la educación continua puede aumentar la adhesión de los profesionales al servicio y mejorar el conocimiento y la comunicación de riesgos del uso de medicamentos.

Pharmacovigilance Programme of India.

Adverse drug reactions from medicinal products are one of the important public health issues. The Pharmacovigilance system is used to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance. It is characterized by its structures, processes and outcomes. To run an effective Pharmacovigilance system a protocol is required for reporting adverse reactions associated with drug use.

Reacciones adversas medicamentosas y errores de prescripción: morbi-mortalidad / Adverse drug reactions and prescription errors: morbi-mortality

La farmacovigilancia tiene por objeto la detección, evaluación, comprensión y prevención de cualquier problema relacionado a las drogas. La recolección de información relacionada a reacciones adversas medicamentosas (RAM) posterior a la aprobación y el manejo del riesgo basados en los datos observacionales son críticos para la salud pública.El objetivo primario fue evaluar la morbimortalidad de las reacciones adversas medicamentosas y describir los errores médicos de prescripción en un hospital público de la Ciudad de Buenos Aires. Se llevó a cabo un estudio prospectivo observacional. Se definió RAM como cualquier manifestación nociva, clínica y/o biológica imputable a un medicamento, que ocurra a las dosis habitualmente utilizadas en humanos para la profilaxis, diagnóstico o tratamiento de una enfermedad. La mortalidad global fue del 7% (21/310) y la atribuible a RAM observada fue del 1% (3/310). Se identificaron 149 RAMs en el 36% de los pacientes (111/310) y las RAM constituyeron el 11% (35/310) de los motivos de internación. Las RAM causan un número significativo de internaciones y son responsables de morbilidad evitable durante la internación. Ningún fármaco aislado causó más del 6% de las RAM, por lo que las estrategias para disminuirlas deben estar dirigidas a múltiples grupos farmacológicos.

Pharmacovigilance aims to detect, assess, understand and prevent any possible drug-related problem. The record of information related to adverse drug reactions (ADRs) after drug approval and risk management based on observational data are crucial for public health. The main goal was to assess the ADRs morbimortality and to describe prescription medical errors in a public hospital in the city of Buenos Aires. A prospective observational study was undertaken. ADR was defined as any clinical and/or biological noxious manifestation imputable to a drug, which occurs at the usually used dose in humans for disease prophylaxis, diagnosis or treatment. Global mortality was 7% (21/310). The observed mortality due to ADR accounted for 1% (3/310). One hundred and forty nine ADRs in 36% of patients were identified (111/310), and 11% (35/310) of the hospital admissions were due to ADRs. ADRs cause a great number of admissions and are responsible for preventable morbidity during hospitalization. Neither drug alone caused more than 6% of the ADRs. For this reason, in order to diminish ADRs, strategies should be addressed to multiple drug groups.

Reporte de eventos adversos en una unidad de cuidados intensivos de Tunja, Colombia / [Adverse event reporting in an intensive care unit at Tunja, Colombia].

INTRODUCTION: Patient safety in critical areas has been subject of several studies. In Colombia, there is a growing conscience about adverse events management. This study explores the first phase of this management: report in a typical private intensive care unit. OBJECTIVE: To assess adverse event report at a Colombian tertiary level institution, through frequency and report category assessment. METHODS: A descriptive study regarding adverse event report rates during 2011 period in Clinica de los Andes de Tunja, was carried out, through frequency and report category assessment. Adverse event report rate was defined as the number of reports per 1000 patient bed. We reported major and minor categories of events. RESULTS: A total of 383 admissions (2374 patient days) were recorded. 54 adverse events were reported (rate of 22,74 per 1000 patient days). The most frequent events were related to intravenous route (55

50,1-58,3) followed by process deviation (22

18,2-26,1). CONCLUSIONS: An adverse event report rate close to the upper limit of literature reports numbers was found. Probably, there is still non quantified under-report of adverse events, likely due to cultural factors.

Eventos adversos pós-vacinação contra influenza pandêmica A (H1N1) 2009 em crianças / Adverse events following vaccination against pandemic influenza A (H1N1) 2009 in children

O objetivo do estudo foi estimar a frequência e os fatores associados à ocorrência de eventos adversos pós-vacinação contra a influenza pandêmica A (H1N1) 2009 em crianças com idade entre seis meses e dois anos. Participaram do estudo 156 crianças. Modelos multivariados de regressão de Cox foram construídos para avaliar a associação independente de cada covariável e a queixa de pelo menos um evento adverso. A força da associação foi medida pela hazard ratio e seus respectivos intervalos de 95% de confiança. Após a primeira dose, foi relatado algum tipo de evento adverso por 40,3% dos participantes e, após a segunda, por 35,5%. Os eventos sistêmicos foram mais frequentes que os locais, destaque para irritabilidade, diarreia e febre. As incidências de eventos adversos, no geral e sistêmicos, após a primeira dose, foram maiores nas crianças com doença concomitante/alergia em relação àquelas sem o agravo (HR = 3,43; IC95%: 1,34-8,77 e HR = 2,76; IC95%: 1,11-6,89). A maioria dos eventos foi de intensidade leve. Febre alta, vômito e diarreia motivaram a busca por serviços de saúde.

The aim of this study was to estimate the frequency of adverse events following vaccination against pandemic influenza A (H1N1) 2009 and associated factors in children from six months to two years of age (n = 156). Multivariate Cox regression was used to assess the independent associations between covariates and complaints of at least one adverse event. Strength of association was measured by hazard ratios and respective 95% confidence intervals. Following the first dose, 40.3% of parents reported one or more adverse events in their children, compared to 35.5% after the second dose. Systemic adverse events, specifically irritation, diarrhea, and fever, were more frequent than local reactions at the vaccination site. Incidence rates for adverse events in general and systemic reactions following the first dose were higher in children with concomitant illness or allergies (HR = 3.43, 95%CI: 1.34-8.77 and HR = 2.76, 95%CI: 1.11-6.89). Most events were mild. Cases of high fever, vomiting, and diarrhea prompted parents to seek care for their children at health services.

Spontaneously Reported Hepatic Adverse Drug Events in Korea: Multicenter Study

Hepatic adverse drug reactions (ADRs) to certain drugs may differ within each country, reflecting different patterns of prescription, socioeconomic status, and culture. The purpose of this study was to assess the suspected cause of hepatic ADRs using the spontaneously reported pharmacovigilance data from Korea. A total of 9,360 spontaneously reported adverse drug events (ADEs) from nine Pharmacovigilance Centers were analyzed. Risk of hepatic ADEs was assessed by calculating the reporting odds ratio (ROR). Of the 9,360 cases, 567 hepatic ADEs were reported. The most frequently prescribed drug classes inducing hepatic ADEs were anti-tuberculotics, cephalosporins, valproic acids, penicillins, quinolones, non-steroidal anti-inflammatory drugs (NSAIDs), anti-viral agents, and statins. ROR values were especially high in anti-tuberculosis drugs, systemic antifungal drugs for systemic use, anti-epileptics, propylthiouracil, and herbal medicines. Underlying diseases such as tuberculosis (6.9% vs 0.9%), pneumonia (4.9% vs 1.7%), intracranial injury including skull fracture (4.5% vs 0.9%), HIV (3.4% vs 0.4%), subarachnoid hemorrhage (2.8% vs 0.5%), and osteoporosis (2.4% vs 1.4%) were significantly more common in hepatic ADE group. In conclusion, anti-infective drugs, anti-epileptics, NSAIDs and statins are the most common suspects of the spontaneously reported hepatic ADEs, in Korea. Careful monitoring for such reactions is needed for the prescription of these drugs.

Prevalência de admissão hospitalar por reação adversa a medicamentos em Salvador, BA / Prevalence of hospital admission due to adverse drug reaction in Salvador, Bahia

OBJETIVO: Determinar a prevalência de admissão por RAM em hospitais de Salvador-BA e seus desfechos. MÉTODOS: Todos os pacientes admitidos nos quatro hospitais sentinela da Anvisa em Salvador-BA foram avaliados e seguidos para determinar a prevalência de admissão por RAM e seus desfechos de abril a dezembro de 2007. Os casos foram validados por três algorítmos. Os medicamentos foram classificados pelo Anatomical-Therapeutic-Chemical Classification, órgãos e sistemas afetados pelos critérios da OMS e a gravidade segundo Pearson et al. O tipo seguiu critérios de Rawlins e Thompson. RESULTADOS: A prevalência de admissão por RAM foi 0,56 por cento e corrigida (expostos) de 2,1 por cento, com 316 casos. Tempo médio de hospitalização por RAM foi de 12,3 dias. Jovens e idosos representaram 28,8 por cento e 31,1 por cento dos pacientes. Gênero feminino e raça negra corresponderam a 60 por cento dos casos. Os principais grupos farmacológicos envolvidos foram antineoplásicos, antibióticos e diuréticos, afetando pele, sistema gastrointestinal e hematológico. Reações certas ou provadas corresponderam 70 por cento, 80 por cento dos casos foram do tipo A, com 90 por cento recuperáveis e um óbito. CONCLUSÃO: A prevalência de admissão por RAM foi semelhante às descritas na literatura e somente um paciente foi a óbito. Por tratar-se do primeiro estudo nacional, servirá de base para futuras investigações.

OBJECTIVE: To determine the prevalence of hospital admissions due to ADR in Salvador, Bahia and their outcomes. METHODS: All patients admitted in four Sentinel Hospital (ANVISA) in Salvador-Ba were evaluated and followed to determine the prevalence of admissions due to ADR and their outcomes from April to December 2007. Cases were validated by 03 algorithms. The drugs were classified by Anatomical-Therapeutic-Chemical Classification, organs and systems affected by the WHO criteria and severity seconds Pearson et al. Type of ADR was analyzed by Rawlins and Thompson. RESULTS: The prevalence of ADR admission was 0.5 percent and adjusted for exposed was 2.1 percent, with 316 cases. Average of hospitalization due to ADR was 12.3 days. Younger and older accounted for 28.8 percent and 31.1 percent of patients. Females and blacks were 60 percent of cases. Main pharmacologic groups were antineoplastics, antibiotics and diuretics, affecting skin, gastrointestinal and hematologic systems. Around 70 percent of the ADR was validated as defined. ADR of type A was 80 percent and 90 percent recovered, and one death (0.5 percent). CONCLUSION: The prevalence of ADR admission was similar to those described in the literature and only one patient died. As this is the first national study will form the basis for future investigations.

Reporte de reacciones adversas a medicamentos con compromiso mucocutáneo en el Hospital Clínico Universidad de Chile durante los años 2004-2010 / Report of adverse reactions to medecines with mucocutáneo commitment in the Hospital Clínico Universidad de Chile during years 2004-2010

Adverse drug reactions (ADRs) are responsible for up to 10percent of hospital admissions worldwide; within them, that mucocutaneous reactions are the most common represented 30percent of the total. The aim of this study was to analyze 119 reports of ADRs recorded in the Pharmacy Department of University of Chile Clinical Hospital in the period 2004-2010 by gender, age, most frequent clinical presentations, drugs and health personnel linked to the notification. In addition, we tried to quantify the relative importance of mucocutaneous reactions in the total of reported ADRs. ADRs were more common in women (56.3percent). The average age was 52.84 years + / - 7.77, 52.07 + / - 10.6 for women and 53.84 + / - 13.43 for men without significant differences (p = 0.85). According to the clinical presentation, mucocutaneous reactions were the most frequent (31.1percent) followed by hematological (25.2percent). The drugs involved were chemotherapy (68.9percent), antibiotics (5.9percent) and NSAIDs, nonsteroidal anti-inflammatory drugs, (4.2percent). In health personnel linked to the notification, we found the association medical / pharmaceutical chemist was the most frequent (40.3percent), followed by a pharmaceutical chemist (33.6percent). In mucocutaneous ADRs we observed a mean age of 54.65 + / - 9.19 years and female predominance (62.2percent). According to the clinical dermatology, we observed a prevalence of skin rash (35.1percent), mucositis (21.6percent), facial erythema (16.2percent) and pruritus (16.2percent). The drugs involved were chemotherapy (78.4percent), antibiotics (8percent), antiretroviral therapy (5percent) and opioids (5percent). Finally, we found that according to time of onset, delayed reactions were the most frequent (43.2percent).

Farmacovigilancia activa en pacientes afiliados al sistema general de seguridad social en salud / Active pharmacosurveillance of patients affiliated to the Colombian general social security/health system

Objetivos Determinar los posibles resultados negativos asociados a la medicación mediante la metodología de búsqueda activa de posibles interacciones medicamentosas en bases de datos de pacientes afiliados al Sistema General de Seguridad Social en Salud. Métodos A partir de las bases de datos de dispensación de medicamentos de Audifarma S.A a unos 4 millones de usuarios del país, se hizo una revisión sistemática de estadísticas de una serie de medicamentos identificados por presentar interacciones de riesgo, dosis diferentes a las recomendadas o dispensación irregular. Los casos son socializados con las EPS responsables. Resultados Se encontró un caso de nefrotoxicidad por ácido zoledrónico; el 37,0 por ciento de los usuarios de clopidogrel recibían concomitantemente omeprazol, que reduce la efectividad del primero; el 29,9 por ciento de los pacientes que toman losartan están recibiendo dosis superiores a las recomendadas para su indicación; el 2,0 por ciento de los pacientes que toman metoprolol o verapamilo, los recibe simultáneamente, con riesgo de generar bradicardia sinusal, bloqueos auriculoventriculares o disfunción sistólica. Todos los casos fueron notificados a los responsables en la EPS que atienden estos pacientes. Discusión La farmacovigilancia activa permite optimizar recursos, prevenir eventos adversos que puedan potencialmente causar morbilidad importante o incluso letalidad o determinar problemas que podrían ser responsables del fracaso terapéutico. Este tipo de estrategia se anticipa a la aparición de posibles riesgos para el paciente por lo que se recomienda considerarla para reforzar los programas de vigilancia de uso de medicamentos en el país.

Objectives Determining negative results associated with medication through an active search of possible drug interactions in databases for patients affiliated to the Colombian general social security/health system. Methods Statistics related to Audifarma S.A. dispensation drug databases for about 4 million Colombian users were systematically reviewed for identifying drugs having known interactions involving risk, doses different from recommended ones or irregular dispensation. The pertinent health-care providing services were made aware of the above. Results There was one case of nephrotoxicity being caused by zoledronic acid. 37 percent of clopidogrel users concomitantly received omeprazole which reduces the former's effectiveness. 29.9 percent of patients who were taking losartan were receiving doses higher than the recommended ones. 2.0 percent of patients who were taking metoprolol or verapamil were simultaneously receiving them, at the risk of generating first-degree heart block, bradycardia, or systolic dysfunction. All these cases were notified to the pertinent health-care services. Conclusions Active pharmacosurveillance leads to resources being optimised, adverse events which can potentially cause morbidity or lethality being prevented or even determining problems which could be responsible for therapeutic failure. This type of strategy anticipates the appearance of possible risks for patients, meaning that drug use monitoring programmes in Colombia should be reinforced.

Reacciones adversas a vacuna DPT del Programa Nacional de Inmunizaciones / Adverse reactions to diphtheria-pertussis-tetanus vaccine in the Chilean Immunization Program

Background: During 2005, the surveillance system of the Chilean Immunization Program detected an increased number of adverse reaction notifications associated to diphtheria, pertussis and tetanus whole-cell vaccine (DPT), coincidentiy with a change in the vaccine manufacturer. Aim: To compare the reactogenicity of two DPT formulations (vaccines 1 and 2) in 18-month-old infants and 4-year-old children. Material and methods: Severe adverse reactions to DPT were studied at the emergency room of two hospitals of Santiago in a case-control study (110 cases and 171 controls, who consulted for other causes). Simultaneously the incidence of total adverse reactions (mild and severe) for vaccine 1 and 2 was estimated in a cohort of 1,017 children vaccinated in an ambulatory health center of the same área. The formulation of DPT received by all participants was verífied, as well as the temporal relation with consultation or symptoms referred by their caregivers. Results: There was a greater probability of consulting at the emergency rooms for severe adverse reactions among children who received vaccine 1 (odds ratio (OR) =7.1; p <0.001), being greater among 4-year-old children (OR =18.9; p <0.001). Coincidentiy, in the cohort of vaccinated children, those who received vaccine 1 had a higher risk of presenting adverse reactions (RR =2.9; p <0.001), being high fever the commonest. Conclusions: We confirmed that vaccine 1 was associated to a higher risk of adverse reactions, especially among 4-year-old children. These results allowed the sanitary authority to adopt an informed decisión. The usefulness of observational studies in vaccine adverse reactions is confirmed.

Adverse drug events in hospitals: a systematic review / Eventos adversos a medicamentos em hospitais: uma revisão sistemática

The objective of this study was to evaluate studies on the occurrence of adverse drug events (ADEs) in hospitals in order to learn about their frequency and characteristics, comparing the methods for identifying them and the various definitions. A search was conducted on MEDLINE and identified studies published from 2000 to 2009. Inclusion criteria were: studies in populations not selected for specific diseases or drugs and ADEs that occurred during hospitalization. Twenty-nine studies were selected, displaying multiple sources of heterogeneity, including differences in the study populations, surveillance techniques, definitions of ADEs, and indicators. The proportion of patients with ADEs ranged from 1.6 percent to 41.4 percent of inpatients and the rates ranged from 1.7 to 51.8 events/100 admissions. A considerable share of these events could have been avoided. The findings show that ADEs in inpatients are a public health problem. However, further studies are needed to monitor these adverse events in order to effectively promote safe drug use.

O objetivo foi avaliar estudos sobre a ocorrência de eventos adversos a medicamentos (EAM) em hospitais para conhecer as suas freqüências e características, comparando os métodos de identificação e as definições utilizadas para caracterizá-los. A busca foi realizada no MEDLINE e identificou estudos publicados entre 2000 e 2009. Os critérios de inclusão foram estudos em população não selecionada por patologias ou medicamentos específicos e os EAM ocorridos durante a internação. Foram selecionados 29 estudos e encontradas múltiplas fontes de heterogeneidade entre eles, incluindo diferenças nas populações estudadas, nas técnicas de vigilância, nas definições de EAM e nos indicadores. A freqüência de pacientes com EAM está entre 1,6 por cento e 41,4 por cento dos pacientes internados e as taxas entre 1,7 e 51,8 eventos/100 internações. Uma parte considerável desses eventos poderia ter sido evitada. Os resultados mostram que EAM em pacientes internados são um problema de saúde pública. Entretanto, são necessários novos estudos de monitoramento desses eventos adversos para a efetiva promoção do uso seguro dos medicamentos.

The utility of the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) system for the assessment of adverse drug reactions in hospitalized children.

Although the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) system has been suggested as a practical tool for classifying adverse drug reactions (ADRs), verification of such system has not been examined. The objective of this study was to evaluate the usefulness of the WHO-UMC classification for the diagnosis of ADRs. The gold standard was the results of drug challenges and serum tryptase in cases of anaphylaxis. Twenty-seven children had ADRs classified by the WHO-UMC system. The causality terms were 'certain' in 4/27, 'probable' in 6/27, 'possible' in 10/27 and 'unlikely' in 7/27 of the patients. Skin prick tests and intradermal tests were positive in 1/20 and 1/5 of the patients, respectively. Drug challenges and serum tryptase were positive in 8/26 and 1/3 of the patients, respectively. After complete evaluation, the positive and negative ADRs were documented in 9/27 patients (33.33%) and 18/27 patients (66.67%), respectively. The multi-level likelihood ratios for ADRs using the WHO-UMC system were infinity in causality term 'certain', 2 in 'probable', 0.5 in 'possible', and 0 in 'unlikely'. In conclusion, causality term 'certain' and 'unlikely' of the WHO-UMC system had large impact on the likelihood of ADRs. In contrast, the causality term 'probable' and 'possible' had small impact on the likelihood of ADRs. Drug challenges and serum tryptase were helpful to confirm ADRs categorized by WHO-UMC system.

Farmacovigilancia en sala de clínica médica / Pharmacosurveillance in a clinical department centre

Las reacciones adversas a medicamentos representan entre el 5 y 10 por ciento de las internaciones y son la quinta o sexta causa de muerte en países desarrollados. La farmacovigilancia es una herramienta fundamental para disminuir la morbimortalidad producida por drogas... Las drogas son causa frecuente de prolongación de internación así como también de aumento de la morbimortalidad en pacientes hospitalizados.