Nearly 70 % of adverse events could be prevented. Observing of adverse events is one way for improving the quality of health services and patient safety. The adverse event reporting systems in České Budějovice hospital was mainly subject in the research portion. A mixed research method (qualitatively quantitative) was used for the research portion. The research results are interpreted using tables and graphs.

Os estudos clínicos são importantes para a sociedade, contribuem para o avanço da ciência, geram novos conhecimentos, trazem benefícios, melhoria da qualidade de vida e o bem-estar das pessoas. Devem ser realizados de acordo com os princípios éticos e vários agentes devem estar envolvidos: as autoridades regulatórias, o patrocinador, o pesquisador, o participante de pesquisa e o comitê de ética em pesquisa. Os regulamentos e guias internacionais e nacionais relacionados aos estudos clínicos, entre eles a Diretriz de Boas Práticas Clínicas foram implantados principalmente, para proteger e garantir a segurança e integridade dos participantes de pesquisa. No decorrer dos estudos clínicos podem ocorrer eventos adversos, portanto a plena monitorização é fundamental, pois torna o estudo mais seguro para o participante de pesquisa. Este trabalho teve como objetivo elaborar um manual direcionado a pesquisadores visando orientar a notificação de eventos adversos aos órgãos pertinentes. O estudo foi realizado em quatro etapas. Na primeira etapa realizou-se uma revisão da literatura sobre eventos adversos em estudos clínicos. Na segunda etapa, elaborou-se um manual piloto. Na terceira etapa, o material foi qualificado por um Painel de Especialistas formado por cinco pesquisadores do Hospital Universitário Cassiano Antonio Moraes, que analisaram o conteúdo e responderam a um questionário de onze questões. Na quarta etapa, analisou-se as respostas dos questionários e com as sugestões do Painel de Especialistas aprimorou-se o manual e obteve-se a versão denominada Manual de Procedimentos para Notificação de Eventos Adversos em Estudos Clínicos. Após a apreciação final do produto pela banca do mestrado profissional, o manual será disponibilizado em formato eletrônico, para que vários pesquisadores tenham acesso, em especial os pesquisadores que atuam no Hospital Universitário Cassiano Antonio Moraes e nos hospitais vinculados a rede da Empresa Brasileira de Serviços Hospitalares (EBSERH). / Clinical studies are important to society. They contribute to the advance of science, generate new knowledge, bring benefits, improve the quality of life and the well-being of people. They must be carried out in accordance with ethical principles and several agents should be involved: the regulatory authorities, the sponsor, the researcher, the research participant and the research ethics committee. International and national regulations and guidelines related to clinical studies, including the Clinical Good Practice Guideline, were primarily implemented to protect and ensure the safety and integrity of the research participants. Adverse events can occur during clinical studies; it means that, full monitoring is critical in order to lead the study safer for the research participant. The aim of this work is to elaborate a manual directed at researchers to guide them on the notification of adverse events process to the government organizations. The study was divided in four steps. In the first step, a bibliographic review on adverse events in clinical studies was done. In the second step, a pilot manual was developed. In the third step, the analyzed material was qualified by a Panel of Experts composed of five University Hospital Cassiano Antonio Moraes’ researchers who analyzed the content and answered a questionnaire of eleven questions. In the fourth step, the analyzed questionnaire as well as the Panel of Expert’s suggestions were used for improving the manual, reaching the version called the Manual of Procedures for Notification of Adverse Events in Clinical Studies. After the final evaluation of the product by the master's degree examining board, the manual will be available in electronic format, so that several researchers will have access, especially researchers working in University Hospital Cassiano Antonio Moraes and hospitals linked to the network of the Brazilian Hospital Services Company (EBSERH).

Les événements indésirables (EIs) sont devenus une vraie préoccupation du monde médical, leur réduction étant recherchée pour assurer la meilleure sécurité possible pour les patients. Les EIs sont, selon la HAS, ‘‘ des situations qui s'écartent de procédures ou de résultats escomptés dans une situation habituelle et qui sont ou qui seraient potentiellement sources de dommages’’. Alors que les EIs postopératoires sont étudiés depuis de nombreuses années, ceux ayant lieu au cours des opérations ne le sont que depuis récemment, comme le montre la récente classification des EIs intraopératoires par Kaafarani et al. publié en 2014. Cependant, la classification d'EIs intraopératoires n'est que la première étape pour comprendre les comportements chirurgicaux qui les entraînent.Dans cette thèse, nous présenterons des méthodes pour détecter l'apparition de déviations dues à l'apparition d'EIs intraopératoires et pour identifier des comportements chirurgicaux à partir de modèle de processus chirurgicaux.Ce travail a nécessité de concevoir et développer une modélisation formelle de la rectopexie et des événements indésirables qui sont associés à cette procédure chirurgicale grâceà la mise en place d'ontologies. Cette modélisation formelle nous a permis de bien appréhender le principe de cette opération et de fournir un vocabulaire permettant une annotation détaillé de vidéos endoscopiques de rectopexies, afin de créer des modèles de processus chirurgicaux en jeu.Grâce à l'annotation des vidéos chirurgicales basée sur cette modélisation, nous avons développé une une méthode de détection automatique des déviations dues à l'apparition d'événements indésirables Cette méthode est basée sur un alignement temporel non-linéaire multi-dimensionnel, que nous avons développé, suivi d'un modèle semi-Markovien caché que nous avons entraîné pour déterminer s'il existe des déviations par rapport à une chirurgie de référence et si celles-ci sont dues à des événements indésirables.Cette détection de déviations dues aux événements indésirables est la première étape afin de comprendre les raisons de leurs apparitions. Nous émettons l'hypothèse que leurs apparitions peuvent être expliquées par une succession d’activités, c'est-à-dire un pattern. Pour répondre à cette hypothèse, nous avons mis en place une méthode de découverte de patterns permettant d'identifier les comportements chirurgicaux spécifiques à différents critères. Cette identification de comportements chirurgicaux est réalisée par une classification ascendante hiérarchique avec la mise en place d'une nouvelle métrique basée sur les patterns partagés entre les chirurgies. Afin de valider notre méthode, nous l'avons comparé à deux études mettant en évidence des différences de comportements chirurgicaux, comme par exemple entre différents sites chirurgicaux ou entre deux types de procédure de la même opération. Une fois la méthode validée, nous avons utilisé notre méthode afin de montrer s'il existait des comportements chirurgicaux spécifiques à des données préopératoires et à l'apparition d'événements indésirables.Pour finir, nous revenons sur les contributions les plus importantes de ces travaux à travers une discussion générale et nous proposons différentes pistes pour améliorer nos résultats / L'auteur n'a pas fourni de résumé en anglais

Conselho Nacional de Desenvolvimento CientÃfico e TecnolÃgico / nÃo hà / A Flutamida à um medicamento anti-androgÃnico nÃo esterÃide aprovado para o tratamento do cÃncer de prÃstata. Seu efeito hepatotÃxico foi conhecido desde o inÃcio do perÃodo de comercializaÃÃo, hà mais de 10 anos. Em marÃo e junho de 2002, a Unidade de FarmacovigilÃncia da ANVISA recebeu as primeiras comunicaÃÃes de Ãbitos por hepatite fulminante associados ao uso da substÃncia (medicamento manipulado) em jovens do sexo feminino. A literatura mundial nunca registrara caso semelhante. O objetivo deste trabalho foi revisar e acrescentar informaÃÃes a respeito da seguranÃa da Flutamida quando utilizadas por pacientes do sexo feminino para o tratamento de hirsutismo, acne e alopecia androgenÃtica. Foram realizadas pesquisas para conhecer a indicaÃÃo aprovada em outros paÃses e as notificaÃÃes de reaÃÃes adversas graves em mulheres no banco de dados da OMS. AlÃm disso, por meio de busca ativa, tentou-se identificar outros casos no Brasil; rever as informaÃÃes das bulas de todos os medicamentos comercializados e analisar se as informaÃÃes obrigatÃrias e relevantes para diminuir o risco de reaÃÃes hepÃticas graves estavam presentes. Por fim, foi realizada pesquisa com os prescritores, por meio de questionÃrio eletrÃnico, para conhecer as informaÃÃes de que dispunham sobre a utilizaÃÃo do medicamento em mulheres e comparar estas informaÃÃes com uma revisÃo crÃtica da literatura no que tange à seguranÃa e eficÃcia. Os resultados de todas estas estratÃgias mostraram que a substÃncia tambÃm à utilizada off label em mulheres em outros paÃses, e tambÃm causou reaÃÃes adversas graves, mas nenhum Ãbito no sexo feminino fora relatado. Durante o trabalho, outros casos de Ãbito no Brasil foram identificados. Todas as bulas comercializadas no Brasil mencionavam que a substÃncia nÃo devia ser utilizada por mulheres, assim como mencionavam as reaÃÃes hepÃticas graves. As respostas dos prescritores ao questionÃrio permitem afirmar que a Flutamida se constitui em importante arsenal terapÃutico, e que o risco de seu uso vem sendo subestimado. O trabalho permite concluir que a Flutamida mostra-se eficaz para as condiÃÃes em que vem sendo utilizada em mulheres. Entretanto, os riscos evidenciam uma relaÃÃo benefÃcio/risco inaceitÃvel para as condiÃÃes estÃticas em que vem sendo empregada. / Flutamide is a non steroid anti-androgenic drug used to treat prostate cancer patients. When it became commercialized, more than 10 years ago, the hepatotoxic effect of flutamide was already recognized. In March and July 2002, the first cases of deaths in young females caused by fulminant hepatitis associated to off label use of this substance (magistral drug) was reported to the Pharmacovigilance Office/ANVISA. Up to now, similar cases were not described in the international literature. This work aimed to review and add information about the adequate use of flutamide by female patients to treat hirsutism, acne and androgenetic alopecia. To identify the standard prescriptions and the reported serious reactions in females worldwide, an extensive research through data provided by OMS was conducted. Moreover, using active search we looked for new local cases and review the information from package insert of all commercialized drugs in Brazil to analyze if the required and relevant information warning patients against the serious hepatic risks were provided. Finally, a survey with the prescribers was carried on through the web to identify the available information about the use of this drug in females and to make comparisons with data from the literature about the safety and efficacy of the use of this substance. The results showed that this substance is also used off label by women from other countries, who also presented serious adverse reactions. However, it was not reported any case of female death. Over the study, new cases of obituary occurred in Brazil, despite all analyzed package insert explain that this substance should not be used by females and mention serious hepatic reactions. The answers of the prescribers to the survey indicated that flutamide is an important therapeutic arsenal and that the risk of the use of this substance seem to have been underestimated. We concluded that flutamide is effective for the women treatment which it has been used. However, the threats of this drug point to the unacceptable use of this drug when applied for the esthetic finality.

Submitted by Nadir Basilio (nadirsb@uninove.br) on 2016-04-25T18:52:17Z No. of bitstreams: 1 Maria Aparecida dos Santos Traverzim.pdf: 1790311 bytes, checksum: 7a6d20dee6a1d5d6bad8e90842729788 (MD5) / Made available in DSpace on 2016-04-25T18:52:17Z (GMT). No. of bitstreams: 1 Maria Aparecida dos Santos Traverzim.pdf: 1790311 bytes, checksum: 7a6d20dee6a1d5d6bad8e90842729788 (MD5) Previous issue date: 2015-11-25 / Patient safety is one of the dimensions of quality that has received increasing attention in recent years. The incident detection in patient safety aims to improve the quality of patient care. Incidents and adverse events (AEs) of patient safety should be reported spontaneously contributing for the apprenticeship and to create barriers so that they would not be repeated, but the fear of prosecution and punishment cause its underreporting. The objective of this study was to evaluate the incidence of patient safety incidents in the perinatal period with the use of an extended check list. This research used the inductive method, empirical approach with exploratory, descriptive, cross and as a strategy action research. Population sample was composed by admitted patients in the perinatal unit from June 25th to July 25th, 2015.We evaluated in maternal registry for proper completion of partogram, the patient chart and newborn data. We looked for: uterine rupture, changing the delivery type, returning to the operating room during hospitalization or after discharge, instrumental delivery, complications in the postpartum period, maternal death. In the newborn chart we collected information on neonatal trauma due to childbirth; research proper fetal vitality; Apgar score less than 7, and death of newborns weighing more than 2,500 g, and mother / newborn (NB). For both we looked for the detection of failure to follow the clinical protocol and blood components transfusion. We also evaluated whether these components of the check list were related to incidents or EAs in health care assistance. The total number of patients studied in the period was 249 patients, and we detected 97 AEs (38.9%). Of EAs, 27 (27.8%) were detected by traditional trigger points and 70 (72.8%) extended check list. The Apgar score less than 7 at the fifth minute was detected in 11 (11.3%) of all EAs and seven newborns (7.2% of events) had some type of trauma due to childbirth, 4 NB (4, 1%) were admitted to the ICU with less than 24 hours of birth. It was noted that two patients (2%) had to undergo to further surgery and one of them is still in outpatient treatment in the unit. Two patients (2%) had lacerations third / fourth degree and one patient (1%) uterine rupture diagnosed at the time of cesarean section. In the extended check list we detected failure in medicines in 20.6% of all AEs. In this study we observed a high incidence of clinical protocols violation (39.2%). Nine patients (9.3%) had complications in the postpartum period, two (2.1%) required liaison and one patient (1%) anesthetic complications. / A segurança do paciente é uma dimensão de qualidade que tem recebido atenção crescente nos últimos anos. A detecção de incidentes na área tem como objetivo melhorar a qualidade da assistência. Os incidentes e eventos adversos (EAs) deveriam ser relatados espontaneamente para que haja aprendizado e criação de barreiras para que não se repetam; porém, o receio de processos judiciais e punições leva a subnotificação. O objetivo deste estudo é avaliar sua incidência no período perinatal com o uso de um check list ampliado. A pesquisa utilizou o método indutivo, abordagem empírica com caráter exploratório, descritivo e transversal, e como estratégia a pesquisa-ação. Foram averiguados os atendimentos prestados a pacientes internadas na unidade de medicina perinatal, no período de 25 de junho a 25 de julho de 2015, quanto ao preenchimento adequado do partograma, dados do prontuário materno e do recém-nascido (RN). Também foi averiguado se a mãe apresentou, durante a internação na unidade: rotura uterina, alteração da via de parto durante o procedimento, retorno à sala cirúrgica durante a internação ou pós-alta hospitalar, parto instrumental, intercorrências no período puerperal ou morte materna. Entre os RNs, verificou-se a ocorrência de trauma neonatal devido ao parto, Apgar menor que 7 e morte com peso superior a 2.500g, além de investigação da vitalidade fetal adequada. Para mãe e recem-nascido, verificou-se se foi seguido o protocolo clínico da instituição e transfusão de heomcomponentes. Também avaliamos se esses componentes do check list, quando presentes, estavam relacionados a incidentes ou EAs no atendimento. O total de pacientes estudadas no período foi de 249, sendo detectados 97 EAs (38,9%). Destes, 27 (27,8%) foram detectados pelos trigger points tradicionais e 70 (72,8%) pelo check list ampliado. O índice de Apgar menor que 7 no quinto minuto foi detectado em 11 (11,3%) do total de EAs e 7 RNs (7,2% dos eventos) apresentaram algum tipo de trauma devido ao parto. 4 RNs (4,1%) foram admitidos na UTI com menos de 24h de nascimento. Observou-se que duas pacientes (2%) tiveram que ser submetidas a nova intervenção cirúrgica e que uma delas ainda continua em tratamento ambulatorial na unidade. Duas (2%) apresentaram lacerações de terceiro/quarto grau e uma (1%), rotura uterina diagnosticada no momento da cesárea. No check list ampliado detectamos falhas de medicamentos como causa de 20,6% de todos os EAs. O número de inobservância de protocolos clínicos da instituição também se mostrou com elevada incidência (39,2%). Nove pacientes (9,3%) apresentaram intercorrências no puerpério, duas (2,1%) necessitaram de interconsulta e uma (1%) de intercorrência anestésica.

Os estudos clínicos são importantes para a sociedade, contribuem para o avanço da ciência, geram novos conhecimentos, trazem benefícios, melhoria da qualidade de vida e o bem-estar das pessoas. Devem ser realizados de acordo com os princípios éticos e vários agentes devem estar envolvidos: as autoridades regulatórias, o patrocinador, o pesquisador, o participante de pesquisa e o comitê de ética em pesquisa. Os regulamentos e guias internacionais e nacionais relacionados aos estudos clínicos, entre eles a Diretriz de Boas Práticas Clínicas foram implantados principalmente, para proteger e garantir a segurança e integridade dos participantes de pesquisa. No decorrer dos estudos clínicos podem ocorrer eventos adversos, portanto a plena monitorização é fundamental, pois torna o estudo mais seguro para o participante de pesquisa. Este trabalho teve como objetivo elaborar um manual direcionado a pesquisadores visando orientar a notificação de eventos adversos aos órgãos pertinentes. O estudo foi realizado em quatro etapas. Na primeira etapa realizou-se uma revisão da literatura sobre eventos adversos em estudos clínicos. Na segunda etapa, elaborou-se um manual piloto. Na terceira etapa, o material foi qualificado por um Painel de Especialistas formado por cinco pesquisadores do Hospital Universitário Cassiano Antonio Moraes, que analisaram o conteúdo e responderam a um questionário de onze questões. Na quarta etapa, analisou-se as respostas dos questionários e com as sugestões do Painel de Especialistas aprimorou-se o manual e obteve-se a versão denominada Manual de Procedimentos para Notificação de Eventos Adversos em Estudos Clínicos. Após a apreciação final do produto pela banca do mestrado profissional, o manual será disponibilizado em formato eletrônico, para que vários pesquisadores tenham acesso, em especial os pesquisadores que atuam no Hospital Universitário Cassiano Antonio Moraes e nos hospitais vinculados a rede da Empresa Brasileira de Serviços Hospitalares (EBSERH). / Clinical studies are important to society. They contribute to the advance of science, generate new knowledge, bring benefits, improve the quality of life and the well-being of people. They must be carried out in accordance with ethical principles and several agents should be involved: the regulatory authorities, the sponsor, the researcher, the research participant and the research ethics committee. International and national regulations and guidelines related to clinical studies, including the Clinical Good Practice Guideline, were primarily implemented to protect and ensure the safety and integrity of the research participants. Adverse events can occur during clinical studies; it means that, full monitoring is critical in order to lead the study safer for the research participant. The aim of this work is to elaborate a manual directed at researchers to guide them on the notification of adverse events process to the government organizations. The study was divided in four steps. In the first step, a bibliographic review on adverse events in clinical studies was done. In the second step, a pilot manual was developed. In the third step, the analyzed material was qualified by a Panel of Experts composed of five University Hospital Cassiano Antonio Moraes’ researchers who analyzed the content and answered a questionnaire of eleven questions. In the fourth step, the analyzed questionnaire as well as the Panel of Expert’s suggestions were used for improving the manual, reaching the version called the Manual of Procedures for Notification of Adverse Events in Clinical Studies. After the final evaluation of the product by the master's degree examining board, the manual will be available in electronic format, so that several researchers will have access, especially researchers working in University Hospital Cassiano Antonio Moraes and hospitals linked to the network of the Brazilian Hospital Services Company (EBSERH).

The diploma thesis deals with the topic of human failures during the risk activities. The aim of the work is to apply risk analysis to the operation of a selected unnamed company that processes vegetables. The thesis is divided into three parts. In the first part, the theoretical basis is discussed and serves as a basis for a better understanding of the topic and subsequent elaboration of the analytical part. The analytical part focuses on the characteristics of the selected company, organizational structure, working positions and the operation itself and analyses these issues with the focus on human factor. The last part of the diploma thesis is dealing with suggestions leading to the prevention of human failure in risk activities. The aim of these suggestions is to improve the situation of the company.

The U.S. Food and Drug Administration (FDA) uses the FDA Adverse Event Reporting System (FAERS) to monitor adverse events resulting from pharmaceutical drug use. However, this system has limitations such as not allowing real-time data collection. To address these limitations, the FDA launched the Sentinel Initiative in 2008. This comparative case study was conducted to describe perceptions of investigating the efficacy of the Sentinel Initiative compared with the FAERS. The study was based on the theory of preemption as it emphasized the need for efficient means for providing unquestionable proof that consumers suffered adverse drug effects. The sample included interivews of 20 individuals, who worked closely with the FAERS program and were familiar with the Sentinel Initiative. In-depth key-informant interviews had been conducted to determine the perceptions of the participants regarding the challenges and benefits of the Sentinel Initiative compared with FAERS. To analyze data, content analysis was used. The study concluded that the FAERS and Sentinel Initiative provided a systematic database, which included health data, that could be used to improve public health. Due to the FAERS and Sentinel Initiative, adverse effects of drugs will be recognized and the safety of the patients and the public will be prioritized. The findings of this study have potential social impact for positive change at the societal level, organizational level, and individual level in terms of overall safety of the drugs. Sentinel initiative at its present state complements the existing FAERS and leverage its benefits by connecting at a grass roots level patients to an organization level as well as stakeholders to make an impact in providing safer drugs on the market.

No description available.

En France, 73.3% des décès maternels liés à une hémorragie du post partum (HPP) ont été jugés comme « évitables » par le comité national d’experts en 2006. Le premier objectif de cette recherche a été l’observation des événements indésirables graves (EIG) en obstétrique et l’analyse des facteurs contributifs. Trois études ont été réalisées et ont montré une proportion de cas potentiellement évitables de 22% pour les embarrures, 72% pour les asphyxies néonatales et 73% pour les transferts maternels en service de réanimation. Le second objectif a été l’amélioration de la qualité de la prise en charge de l’HPP, première cause de mortalité maternelle. Deux études ont été réalisées. La première étude a montré que le protocole de prise en charge de l’HPP était appliqué partiellement après sa diffusion passive dans un réseau périnatal en Rhône Alpes. La seconde étude, PITHAGORE 6, un essai randomisé initié dans six réseaux de périnatalité en France pour mesurer l’impact d’un programme d’intervention multifacettes, a permis de réduire le taux d’HPP graves. De nouvelles méthodes doivent être développées en intégrant l’apport des sciences humaines pour optimiser la sécurité des soins en périnatalité. / In France, 73,3% of maternal deaths from post partum haemorrhage (PPH) were considered as «avoidable» by national experts committee in 2006. The first goal of this research was to observe adverse events (AEs) in obstetrics and to analyse latent and active conditions. The three observational studies highlighted that 22% of depressed skull fractures, 72% of birth asphyxia and 73% of maternal transfers to intensive care unit care might have been avoidedThe second aim was to improve PPH management, which is a leading cause of maternal mortality. Two studies were realized. The first has shown that regional guideline of PPH management was partly applied after passive dissemination in a regional perinatal network. The second study, PITHAGORE 6, a randomised trial conducted in six perinatal networks to assess impact of multi-faceted intervention program, reduced the rate of severe PPH. New methods have to be developed and might take into account human sciences to improve safety in perinatal care.