Introdução: A varfarina é um dos anticoagulantes orais (ACO) mais utilizados na atenção primária a saúde. Com janela terapêutica estreita, exibe grande variabilidade de resposta farmacológica, e maior suscetibilidade de eventos adversos, como sangramentos e tromboembolismo venoso. Entre os fatores que influenciam na variabilidade de dose destaca-se as interações tanto com medicamentos, como com a dieta e o polimorfismo genético. Objetivos: Estimar a incidência de eventos adversos relacionados ao uso de varfarina e descrever o itinerário do usuário pelo sistema público de saúde para resolução dos problemas. Métodos: trata-se de uma coorte prospectiva realizada por um período de 18 meses com usuários do serviço público de saúde, em uso de varfarina, do município de Ijuí/RS. Os dados foram coletados por entrevistas mensais nas residências e complementados com informações médicas obtidas na atenção primária e terciária. As interações medicamentosas foram checadas em bases de dados e os hábitos alimentares conforme metodologia validada. A estatística utilizada para associar sangramento e Time in Therapeutic Range (TTR) e os fatores de risco foi teste de Poison. O projeto foi aprovado no Comitê de Ética em Pesquisa da UFRGS, com parecer número 336.259/2013. Resultados: Foram entrevistados e acompanhados 69 pacientes, sendo que 64 concluíram o acompanhamento e 5 faleceram durante o estudo, 55,1% eram do sexo feminino, com idade média de 64,3 ±13,7 anos. O tempo médio de uso de varfarina foi de 5,5 anos, a dose média semanal foi de 30,69±15,19mg e o principal motivo para uso de varfarina foi prótese valvular (39,7%). A média de medicamentos utilizados por usuário foi de 9,6±4,5. Quanto aos eventos, os sangramentos tiveram incidência de 37,7/100 pacientes/ano, o tromboembolismo de 4,8/100 pacientes/ano e de óbitos de 4,8/100 pacientes/ano. Os sangramentos apresentaram associação com possuir mais que três interações medicamentosas com a varfarina (p=0,048) e com uso de medicamentos por automedicação (p=0,030). Já para o TTR houve associação com a idade inferior a 65 anos (p=0,032). E 67 usuários estavam suscetíveis a interações medicamentosasas com varfarina, com predomínio das moderadas, sendo a média de interações com este medicamento de 2,91±1,52. A maioria das interações agiam sobre o efeito anticoagulante da varfarina, aumentando a probabilidade de sangramento. Entre as interações que os usuários apresentavam, no momento do sangramento, as mais frequentes foram com: omeprazol, sinvastatina e paracetamol. A maioria dos entrevistados apresentou consumo baixo de vitamina K. Verificou-se que sangramentos e tromboembolismos venosos foram mais frequentes nos pacientes em início de tratamento. E todos os pacientes que foram a óbito durante o acompanhamento (5) eram pacientes com mais de um ano de uso de varfarina. Para a resolução de eventos adversos na maioria dos casos o paciente realizou cuidado domiciliar (53,4%), seguido por busca pela Unidades Básicas de Saúde, 7 pacientes buscaram o serviço de emergência e 5 realizaram internação hospitalar. Observou-se que aproximadamente metade dos pacientes não mostrou seus exames de INR (Razão Normalizada Internacional) ao médico. E na falta de varfarina na rede pública de saúde do município, que ocorreu entre os meses 13 e 16, entre 24,9 a 43,5%, deixaram de usar o medicamento. Os resultados do polimorfismo demonstram que 47 (71,2%) não apresentam polimorfismo ao genótipo CYP2C9, e 24 (36,4%) ao genótipo VKORC1. Avaliando os dois genótipos associados, verifica-se que 17 (25,8%) não apresentam polimorfismo a nenhum destes. Não foi observada associação estatística do polimorfismo com sexo e raça. Observou-se diferença significativa entre a dose utilizada para os diferentes polimorfismos (p=0,013). Da mesma forma, para o VKORC1, houve diferença significativa entre a dose e o genótipo (p=0,018). Conclusão: Estes resultados demonstram a necessidade de uma maior assistência a estes pacientes, buscando melhores resultados clínicos, com menos eventos adversos. / Introduction: Warfarin is an oral anticoagulant (OAC) most used in primary health care. With narrow therapeutic window, shows great variability in drug response, and greater susceptibility to adverse events such as bleeding and venous thromboembolism. Among the factors that influence the amount of variability highlights the interactions with both drugs, as with diet and genetic polymorphism. Objectives: To estimate the incidence of adverse events related to warfarin use and describe the user journey through the public health system to the problems. Methods: This is a prospective cohort study conducted over a period of 18 months with users of the public health service in the use of warfarin, the city of Ijuí/RS. The data were collected monthly interviews in homes and complemented with medical information obtained in primary and tertiary care. Drug interactions were checked in databases and eating habits as validated methodology. The statistics used to associate bleeding and Time in Therapeutic Range (TTR) and the risk factors was Poison test. The project was approved by the Research Ethics Committee of UFRGS, with opinion number 336259/2013. Results: We interviewed and followed 69 patients, 64 completed the follow-up and 5 died during the study, 55.1% were female, mean age 64.3 ± 13.7 years. The mean duration of warfarin use was 5.5 years, the average weekly dose was 30.69 ± 15,19mg and the main reason for warfarin use was valvular prosthesis (39.7%). The average per user used medications was 9.6 ± 4.5. As for events, the bleeding had incidence of 37.7 / 100 patients / year, thromboembolism of 4.8 / 100 patients / year and deaths of 4.8 / 100 patients / year. Bleeds were associated with having more than three drug interactions with warfarin (p = 0.048) and use of self-medication by drugs (p = 0.030). As for the TTR was no association with age less than 65 years (p = 0.032). And 67 users were susceptible to medicamentosasas interactions with warfarin, with a predominance of moderate, with an average of interactions with this drug of 2.91 ± 1.52. Most interactions acting on the anticoagulant effect of warfarin, increasing the probability of bleeding. Among the interactions that users had, at the time of bleeding, the most common were with: omeprazole, simvastatin and acetaminophen. Most respondents showed low consumption of vitamin K. It was found that bleeding and venous thromboembolism were more frequent in patients starting treatment. And all patients who died during follow-up (5) were patients with more than one year of warfarin use. For adverse event resolution in most cases the patient underwent home care (53.4%), followed by search for the Basic Health Units, 7 patients sought emergency services and 5 held hospitalization. It was observed that approximately half of the patients showed their INR test (International Normalized Ratio) to the doctor. And in the absence of warfarin in public municipal health, which occurred between the months 13:16, from 24.9 to 43.5% stopped using the drug. The polymorphism results demonstrate that 47 (71.2%) did not have the polymorphism CYP2C9 genotype, and 24 (36.4%) the VKORC1 genotype. Evaluating the two genotypes associated, it is found that 17 (25.8%) did not show any polymorphism thereof. There was no statistical association of the polymorphism with gender and race. A significant difference between the dose for different polymorphisms (p = 0.013). Likewise, for the VKORC1, a significant difference between the dose and genotype (p = 0.018). Conclusion: These results demonstrate the need for further assistance to these patients, looking for better clinical outcomes, with fewer adverse events.

Introdução: A varfarina é um dos anticoagulantes orais (ACO) mais utilizados na atenção primária a saúde. Com janela terapêutica estreita, exibe grande variabilidade de resposta farmacológica, e maior suscetibilidade de eventos adversos, como sangramentos e tromboembolismo venoso. Entre os fatores que influenciam na variabilidade de dose destaca-se as interações tanto com medicamentos, como com a dieta e o polimorfismo genético. Objetivos: Estimar a incidência de eventos adversos relacionados ao uso de varfarina e descrever o itinerário do usuário pelo sistema público de saúde para resolução dos problemas. Métodos: trata-se de uma coorte prospectiva realizada por um período de 18 meses com usuários do serviço público de saúde, em uso de varfarina, do município de Ijuí/RS. Os dados foram coletados por entrevistas mensais nas residências e complementados com informações médicas obtidas na atenção primária e terciária. As interações medicamentosas foram checadas em bases de dados e os hábitos alimentares conforme metodologia validada. A estatística utilizada para associar sangramento e Time in Therapeutic Range (TTR) e os fatores de risco foi teste de Poison. O projeto foi aprovado no Comitê de Ética em Pesquisa da UFRGS, com parecer número 336.259/2013. Resultados: Foram entrevistados e acompanhados 69 pacientes, sendo que 64 concluíram o acompanhamento e 5 faleceram durante o estudo, 55,1% eram do sexo feminino, com idade média de 64,3 ±13,7 anos. O tempo médio de uso de varfarina foi de 5,5 anos, a dose média semanal foi de 30,69±15,19mg e o principal motivo para uso de varfarina foi prótese valvular (39,7%). A média de medicamentos utilizados por usuário foi de 9,6±4,5. Quanto aos eventos, os sangramentos tiveram incidência de 37,7/100 pacientes/ano, o tromboembolismo de 4,8/100 pacientes/ano e de óbitos de 4,8/100 pacientes/ano. Os sangramentos apresentaram associação com possuir mais que três interações medicamentosas com a varfarina (p=0,048) e com uso de medicamentos por automedicação (p=0,030). Já para o TTR houve associação com a idade inferior a 65 anos (p=0,032). E 67 usuários estavam suscetíveis a interações medicamentosasas com varfarina, com predomínio das moderadas, sendo a média de interações com este medicamento de 2,91±1,52. A maioria das interações agiam sobre o efeito anticoagulante da varfarina, aumentando a probabilidade de sangramento. Entre as interações que os usuários apresentavam, no momento do sangramento, as mais frequentes foram com: omeprazol, sinvastatina e paracetamol. A maioria dos entrevistados apresentou consumo baixo de vitamina K. Verificou-se que sangramentos e tromboembolismos venosos foram mais frequentes nos pacientes em início de tratamento. E todos os pacientes que foram a óbito durante o acompanhamento (5) eram pacientes com mais de um ano de uso de varfarina. Para a resolução de eventos adversos na maioria dos casos o paciente realizou cuidado domiciliar (53,4%), seguido por busca pela Unidades Básicas de Saúde, 7 pacientes buscaram o serviço de emergência e 5 realizaram internação hospitalar. Observou-se que aproximadamente metade dos pacientes não mostrou seus exames de INR (Razão Normalizada Internacional) ao médico. E na falta de varfarina na rede pública de saúde do município, que ocorreu entre os meses 13 e 16, entre 24,9 a 43,5%, deixaram de usar o medicamento. Os resultados do polimorfismo demonstram que 47 (71,2%) não apresentam polimorfismo ao genótipo CYP2C9, e 24 (36,4%) ao genótipo VKORC1. Avaliando os dois genótipos associados, verifica-se que 17 (25,8%) não apresentam polimorfismo a nenhum destes. Não foi observada associação estatística do polimorfismo com sexo e raça. Observou-se diferença significativa entre a dose utilizada para os diferentes polimorfismos (p=0,013). Da mesma forma, para o VKORC1, houve diferença significativa entre a dose e o genótipo (p=0,018). Conclusão: Estes resultados demonstram a necessidade de uma maior assistência a estes pacientes, buscando melhores resultados clínicos, com menos eventos adversos. / Introduction: Warfarin is an oral anticoagulant (OAC) most used in primary health care. With narrow therapeutic window, shows great variability in drug response, and greater susceptibility to adverse events such as bleeding and venous thromboembolism. Among the factors that influence the amount of variability highlights the interactions with both drugs, as with diet and genetic polymorphism. Objectives: To estimate the incidence of adverse events related to warfarin use and describe the user journey through the public health system to the problems. Methods: This is a prospective cohort study conducted over a period of 18 months with users of the public health service in the use of warfarin, the city of Ijuí/RS. The data were collected monthly interviews in homes and complemented with medical information obtained in primary and tertiary care. Drug interactions were checked in databases and eating habits as validated methodology. The statistics used to associate bleeding and Time in Therapeutic Range (TTR) and the risk factors was Poison test. The project was approved by the Research Ethics Committee of UFRGS, with opinion number 336259/2013. Results: We interviewed and followed 69 patients, 64 completed the follow-up and 5 died during the study, 55.1% were female, mean age 64.3 ± 13.7 years. The mean duration of warfarin use was 5.5 years, the average weekly dose was 30.69 ± 15,19mg and the main reason for warfarin use was valvular prosthesis (39.7%). The average per user used medications was 9.6 ± 4.5. As for events, the bleeding had incidence of 37.7 / 100 patients / year, thromboembolism of 4.8 / 100 patients / year and deaths of 4.8 / 100 patients / year. Bleeds were associated with having more than three drug interactions with warfarin (p = 0.048) and use of self-medication by drugs (p = 0.030). As for the TTR was no association with age less than 65 years (p = 0.032). And 67 users were susceptible to medicamentosasas interactions with warfarin, with a predominance of moderate, with an average of interactions with this drug of 2.91 ± 1.52. Most interactions acting on the anticoagulant effect of warfarin, increasing the probability of bleeding. Among the interactions that users had, at the time of bleeding, the most common were with: omeprazole, simvastatin and acetaminophen. Most respondents showed low consumption of vitamin K. It was found that bleeding and venous thromboembolism were more frequent in patients starting treatment. And all patients who died during follow-up (5) were patients with more than one year of warfarin use. For adverse event resolution in most cases the patient underwent home care (53.4%), followed by search for the Basic Health Units, 7 patients sought emergency services and 5 held hospitalization. It was observed that approximately half of the patients showed their INR test (International Normalized Ratio) to the doctor. And in the absence of warfarin in public municipal health, which occurred between the months 13:16, from 24.9 to 43.5% stopped using the drug. The polymorphism results demonstrate that 47 (71.2%) did not have the polymorphism CYP2C9 genotype, and 24 (36.4%) the VKORC1 genotype. Evaluating the two genotypes associated, it is found that 17 (25.8%) did not show any polymorphism thereof. There was no statistical association of the polymorphism with gender and race. A significant difference between the dose for different polymorphisms (p = 0.013). Likewise, for the VKORC1, a significant difference between the dose and genotype (p = 0.018). Conclusion: These results demonstrate the need for further assistance to these patients, looking for better clinical outcomes, with fewer adverse events.

5 ABSTRACT Candidate: Lenka Polláková1 Supervisor: prof. RNDr. Jiří Vlček, CSc.1 Consultant: doc. MUDr. Tomáš Soukup, Ph.D.2 1 Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University 2 2nd Department of Internal Gastroenterology, University Hospital in Hradec Králové Title of the master thesis: Analysis of non-cardiac adverse event of glucocorticoid pulse therapy Intravenous glucocorticoid pulse therapy (PT GC) is effective in life threatening flares of rheumatic diseases. However, due to GC's pleiotropic effect, higher doses and additive nongenomic mechanism in pulse regimen, it is not free of complications (1). The aim of theoretical part was to describe from literature research the relevance of PT GC, its non- cardiac adverse events (AE) in rheumatic patients and their influencing factors. The aim of experimental part of the study was to analyze the occurrence of non-cardiac AE in real-life setting, analyze risk factors of potential adverse drug reactions (ADR) and its complications and analyze the risk minimalization management in real-life setting. Patients were administered 1000 mg methylprednisolone in 3 to 5 doses on alternating days. Analysis includes 277 rheumatic patients with 325 pulse therapy courses. Data were collected retrospectively from their...

Background Efficacy and safety of treatments for hospitalized COVID-19 are uncertain. We systematically reviewed efficacy and safety of remdesivir for the treatment of COVID-19. Methods Studies evaluating remdesivir in adults with hospitalized COVID-19 were searched in several engines until August 21, 2020. Primary outcomes included all-cause mortality, clinical improvement or recovery, need for invasive ventilation, and serious adverse events (SAEs). Inverse variance random effects meta-analyses were performed. Results We included four randomized controlled trials (RCTs) (n = 2296) [two vs. placebo (n = 1299) and two comparing 5-day vs. 10-day regimens (n = 997)], and two case series (n = 88). Studies used intravenous remdesivir 200mg the first day and 100mg for four or nine more days. One RCT (n = 236) was stopped early due to AEs; the other three RCTs reported outcomes between 11 and 15 days. Time to recovery was decreased by 4 days with remdesivir vs. placebo in one RCT (n = 1063), and by 0.8 days with 5-days vs. 10-days of therapy in another RCT (n = 397). Clinical improvement was better for 5-days regimen vs. standard of care in one RCT (n = 600). Remdesivir did not decrease all-cause mortality (RR 0.71, 95% CI 0.39 to 1.28, I2 = 43%) and need for invasive ventilation (RR 0.57, 95%CI 0.23 to 1.42, I2 = 60%) vs. placebo at 14 days but had fewer SAEs; 5-day decreased need for invasive ventilation and SAEs vs. 10-day in one RCT (n = 397). No differences in all-cause mortality or SAEs were seen among 5-day, 10-day and standard of care. There were some concerns of bias to high risk of bias in RCTs. Heterogeneity between studies could be due to different severities of disease, days of therapy before outcome determination, and how ordinal data was analyzed. Conclusions There is paucity of adequately powered and fully reported RCTs evaluating effects of remdesivir in hospitalized COVID-19 patients. Until stronger evidence emerges, we cannot conclude that remdesivir is efficacious for treating COVID-19. / Revisión por pares

Bakgrund: Patientsäkerhet innebär förebyggande av vårdskador och är en global och allvarlig fråga. I Europa förväntas var tionde patient att få en vårdskada som kunnat förebyggas. Förutom de ekonomiska kostnaderna orsakar vårdskador lidande för patienterna och för sjukvårdspersonalen. Patienten kan uppleva att kroppens gränser överskridits av att en annan människa berört kroppen, sjukvårdspersonalen påverkas både på ett professionellt och personligt plan av att ha varit involverad i en vårdskada. Syfte: Syftet med litteraturöversikten var att belysa patienters upplevelse av att drabbas av vårdskador. Metod: Litteraturöversikt och analys av elva kvalitativa studier enligt Friberg. Resultat: Litteraturöversikten resulterade i fem huvudteman och fem subteman. Upplevelser av bristande information och kommunikation var vanliga samt att livet begränsades efter vårdskadan. Vårdskadan medförde dessutom påfrestningar av både fysisk och psykisk karaktär. Många patienter ville förhindra att samma sak skulle drabba någon annan i framtiden. Patienter upplevde att de kunnat vända den påfrestande upplevelsen till något positivt. Diskussion: Patienter behöver få ärlig och fullständig information om vad som hänt när en vårdskada inträffat, det är mer sannolikt att patientens respons blir positiv då. Om patienten möts med värdighet så kan det lindra den enskilda patientens lidande. Patienter som upplevt försoning med det inträffade kan tillskriva det genomlevda lidandet en mening. Behov av att få prata om det som hänt finns både för de drabbade patienterna samt för inblandad sjukvårdspersonal, som i denna kontext kallas för det andra offret. / Background: Patient safety involves the prevention of adverse events and is a global and serious issue. In Europe one out of ten patients is expected to suffer from an adverse event that could have been prevented. Except the economic costs adverse events cause suffering for both patients and medical staff. The patient may experience that the body´s boundaries have been exceeded when another human being touched the body, the medical staff who had been involved in an adverse event are affected both on a professional and personal level. Aim: The aim of this study was to explore patients’ experiences of suffering from adverse events. Method: A literature review and analysis of eleven qualitative articles according to Friberg. Results: The literature review resulted in five main themes and five subthemes. Experiences of lack of information and communication were usual and also that life became restricted because of the adverse event. The adverse events also caused stress of both physical and psychological nature. Many patients wanted to prevent that the same thing would happen to someone else in the future. A few felt that they could turn the stressful experience into something positive Discussion: Patients must receive honest and complete information on what happened after an adverse event, it is more likely that the patient's response is positive then. If the patient is treated with dignity it may relieve the individual patient's suffering. Patients who have experienced reconciliation with the incident can ascribe the suffering a meaning. There is a need to talk about the adverse event, both for the patients and for the involved professionals, which in this context is called the second victim.

Segurança do paciente implica em reduzir riscos de dano desnecessário ao mínimo aceitável, causado pela assistência/cuidado e não pela doença, com utilização de boas práticas assistenciais, baseada em evidências científicas. As notificações de incidentes/eventos adversos configuram-se indicadores da qualidade dos serviços de saúde e sua ocorrência produz resultados indesejáveis que afetam a segurança do paciente. As notificações voluntárias de incidentes são instrumentos nos quais profissionais, instituições e indivíduos podem relatar problemas relacionados a segurança do paciente, e por meio da investigação e análise dos incidentes gerar informações uteis para melhoria dos processos assistenciais. Objetivo. Analisar as notificações de incidentes relacionados à segurança do paciente em um hospital público do interior do estado de São Paulo, de agosto de 2015 a julho de 2016. Método. Trata-se de um estudo descritivo, retrospectivo de análise documental, com abordagem quantitativa, com base nos dados do Serviço de Gerenciamento de Risco. Resultados. Foram analisadas 4.691 notificações. O enfermeiro foi a categoria profissional que mais notificou (n=3312; 71%), seguido do médico (n=373; 8%). O período mais frequente em que ocorreram as notificações foi o diurno. Houve diferença significativa da proporção de notificações entre os dias da semana. As notificações foram classificadas por motivo e os de maior prevalência neste estudo foram os relacionadas a medicamentos 807 (17%), seguido de lesões de pele 695 (15%), flebite 650 (14%) incidentes, artigos médico-hospitalar 630 (13%) e 299 (6%) quedas. A maior frequência de notificações ocorreu nas Unidades de Internação. Quanto a gravidade 344 eventos ocasionaram dano ao paciente, sendo a maioria de intensidade leve (n=224, 65%). Nos incidentes relacionados a medicamentos, contatou-se que os erros de medicamentos ocorreram com mais frequência (51%), seguido dos desvios de qualidade (27%). As ocorrências de flebite foram classificadas em grau, sendo o grau II o mais prevalente (47%), seguido do grau I (30%), o sexo masculino foi predominante, e o tempo de permanência do cateter prevalente foi menor que 72 horas, juntamente com dispositivos flexíveis de calibre 22 e curativo estéril com visualização. As quedas foram em sua maioria sem danos, mais frequentes no sexo masculino (59%), na enfermaria/quarto (61%) e no banheiro (20%). Quanto ao tipo de queda predominaram as da própria altura (44%), seguida do leito (20%). Nas lesões de pele predominou as lesões por pressão (94%), de estágio 2 (63%). Conclusão. As notificações espontâneas são uma importante fonte de informações, alerta para promoção da segurança no ambiente hospitalar e evidencia a magnitude do problema relacionado aos incidentes em saúde. A notificações estão muito centradas na figura do enfermeiro e todos os profissionais, principalmente os da linha de frente, devem compreender a importância das notificações para a assistência segura ao paciente. Há necessidade de fortalecer a cultura da segurança do paciente e os profissionais devem estar seguros que a notificação das falhas não implica em ações disciplinares. Falhas acontecem e é possível aprender a partir dos erros, a fim de evitá-los e promover ações que garantam uma prática mais segura / Patient safety implies in reducing risk of unnecessary damage to the minimum acceptable, caused by assistance/care and not by illness, using best practices, scientific evidence-based assistance. Notifications of incident/adverse events constitute indicators of quality of health services and their occurrence produce undesirable results that affect patient safety. Voluntary notifications of incidents are instruments in which professionals, institutions and individuals can report problems related to patient safety, and through research and analysis of incidents to generate useful information for improving assistance processes. Objective. Analyze incident notifications related to the patient\'s safety in a public hospital within the state of São Paulo, from August 2015 to July 2016. Method. It is a descriptive, retrospective study of documentary analysis, with quantitative approach, based on data from the risk Management service. Results. 4.691 notifications were analyzed. The nurse was the Professional category that most notified (n=3.312; 71%), followed by the Doctor (n=373; 8%). The most frequent period in which the notifications occurred was the daytime. There was significant difference in the proportion of notifications between the days of the week. The notifications were classified by reason and the most prevalence in this study were those related to medications 807 (17%), followed by skin lesions 695 (15%), Phlebitis 650 (14%) incidents, hospital medical articles 630 (13%) and 299 (6%) Falls. The highest frequency of notifications occurred in the internment units. In relation to severity, 344 events caused damage to the patient, being the most of light intensity (n=224; 65%). In drug related incidents, it was contacted that drug errors occurred more frequently (51%), followed by quality deviations (27%). The occurrences of phlebitis were classified in degree, the grade II being the most prevalent (47%), followed by grade I (30%), the male was prevalent, and the time remained of the prevalent catheter was less than 72 hours, along with devices Flexible 22 caliber and sterile dressing with visualization. The falls were mostly with no damage, more frequent in males (59%), in the infirmary/room (61%) and in the bathroom (20%). The type of fall predominated were those of the height (44%), followed by the bed (20%). In skin lesions, pressure lesions predominated (94%), stage 2 (63%). Conclusion. Spontaneous notifications are an important source of information, alert to promote safety in the hospital environment and evidence the magnitude of the problem related to health incidents. The notifications are very focused on the figure of the nurse and all professionals, especially the front line, must understand the importance of notifications for safe patient care. There is a need to strengthen the patient safety culture and practitioners should be assured that failure reporting does not entail disciplinary action. Failures happen and it is possible to learn from mistakes in order to avoid them and promote actions that ensure a safer practice

Segurança do paciente implica em reduzir riscos de dano desnecessário ao mínimo aceitável, causado pela assistência/cuidado e não pela doença, com utilização de boas práticas assistenciais, baseada em evidências científicas. As notificações de incidentes/eventos adversos configuram-se indicadores da qualidade dos serviços de saúde e sua ocorrência produz resultados indesejáveis que afetam a segurança do paciente. As notificações voluntárias de incidentes são instrumentos nos quais profissionais, instituições e indivíduos podem relatar problemas relacionados a segurança do paciente, e por meio da investigação e análise dos incidentes gerar informações uteis para melhoria dos processos assistenciais. Objetivo. Analisar as notificações de incidentes relacionados à segurança do paciente em um hospital público do interior do estado de São Paulo, de agosto de 2015 a julho de 2016. Método. Trata-se de um estudo descritivo, retrospectivo de análise documental, com abordagem quantitativa, com base nos dados do Serviço de Gerenciamento de Risco. Resultados. Foram analisadas 4.691 notificações. O enfermeiro foi a categoria profissional que mais notificou (n=3312; 71%), seguido do médico (n=373; 8%). O período mais frequente em que ocorreram as notificações foi o diurno. Houve diferença significativa da proporção de notificações entre os dias da semana. As notificações foram classificadas por motivo e os de maior prevalência neste estudo foram os relacionadas a medicamentos 807 (17%), seguido de lesões de pele 695 (15%), flebite 650 (14%) incidentes, artigos médico-hospitalar 630 (13%) e 299 (6%) quedas. A maior frequência de notificações ocorreu nas Unidades de Internação. Quanto a gravidade 344 eventos ocasionaram dano ao paciente, sendo a maioria de intensidade leve (n=224, 65%). Nos incidentes relacionados a medicamentos, contatou-se que os erros de medicamentos ocorreram com mais frequência (51%), seguido dos desvios de qualidade (27%). As ocorrências de flebite foram classificadas em grau, sendo o grau II o mais prevalente (47%), seguido do grau I (30%), o sexo masculino foi predominante, e o tempo de permanência do cateter prevalente foi menor que 72 horas, juntamente com dispositivos flexíveis de calibre 22 e curativo estéril com visualização. As quedas foram em sua maioria sem danos, mais frequentes no sexo masculino (59%), na enfermaria/quarto (61%) e no banheiro (20%). Quanto ao tipo de queda predominaram as da própria altura (44%), seguida do leito (20%). Nas lesões de pele predominou as lesões por pressão (94%), de estágio 2 (63%). Conclusão. As notificações espontâneas são uma importante fonte de informações, alerta para promoção da segurança no ambiente hospitalar e evidencia a magnitude do problema relacionado aos incidentes em saúde. A notificações estão muito centradas na figura do enfermeiro e todos os profissionais, principalmente os da linha de frente, devem compreender a importância das notificações para a assistência segura ao paciente. Há necessidade de fortalecer a cultura da segurança do paciente e os profissionais devem estar seguros que a notificação das falhas não implica em ações disciplinares. Falhas acontecem e é possível aprender a partir dos erros, a fim de evitá-los e promover ações que garantam uma prática mais segura / Patient safety implies in reducing risk of unnecessary damage to the minimum acceptable, caused by assistance/care and not by illness, using best practices, scientific evidence-based assistance. Notifications of incident/adverse events constitute indicators of quality of health services and their occurrence produce undesirable results that affect patient safety. Voluntary notifications of incidents are instruments in which professionals, institutions and individuals can report problems related to patient safety, and through research and analysis of incidents to generate useful information for improving assistance processes. Objective. Analyze incident notifications related to the patient\'s safety in a public hospital within the state of São Paulo, from August 2015 to July 2016. Method. It is a descriptive, retrospective study of documentary analysis, with quantitative approach, based on data from the risk Management service. Results. 4.691 notifications were analyzed. The nurse was the Professional category that most notified (n=3.312; 71%), followed by the Doctor (n=373; 8%). The most frequent period in which the notifications occurred was the daytime. There was significant difference in the proportion of notifications between the days of the week. The notifications were classified by reason and the most prevalence in this study were those related to medications 807 (17%), followed by skin lesions 695 (15%), Phlebitis 650 (14%) incidents, hospital medical articles 630 (13%) and 299 (6%) Falls. The highest frequency of notifications occurred in the internment units. In relation to severity, 344 events caused damage to the patient, being the most of light intensity (n=224; 65%). In drug related incidents, it was contacted that drug errors occurred more frequently (51%), followed by quality deviations (27%). The occurrences of phlebitis were classified in degree, the grade II being the most prevalent (47%), followed by grade I (30%), the male was prevalent, and the time remained of the prevalent catheter was less than 72 hours, along with devices Flexible 22 caliber and sterile dressing with visualization. The falls were mostly with no damage, more frequent in males (59%), in the infirmary/room (61%) and in the bathroom (20%). The type of fall predominated were those of the height (44%), followed by the bed (20%). In skin lesions, pressure lesions predominated (94%), stage 2 (63%). Conclusion. Spontaneous notifications are an important source of information, alert to promote safety in the hospital environment and evidence the magnitude of the problem related to health incidents. The notifications are very focused on the figure of the nurse and all professionals, especially the front line, must understand the importance of notifications for safe patient care. There is a need to strengthen the patient safety culture and practitioners should be assured that failure reporting does not entail disciplinary action. Failures happen and it is possible to learn from mistakes in order to avoid them and promote actions that ensure a safer practice

Bakgrund: Vårdskador är vanligt förekommande i både svensk och utländsk sjukvård. Överlag bidrar vårdskadorna med flera dygns förlängda vårdtider och upptar ett stort antal vårdplatser. Detta upptar resurser och kostar samhället många miljarder kronor varje år. Hälso- och sjukvårdspersonal ansvarar för patientsäkerheten i vården, vilket i Sverige är reglerat i lagar och föreskrifter. Dessa finns till för att skydda patienter mot vårdskador och innebär en skyldighet för hälso- och sjukvården att ständigt jobba för att utveckla kvalitet och säkerhet i vården. Syfte: Syftet med litteraturöversikten var att beskriva patienters upplevelser av att drabbas av vårdskada. Metod: En litteraturöversikt enligt Friberg har genomförts. Sökning efter resultatartiklar till översikten gjordes i CINAHL Complete och PubMed. Elva originalartiklar hittades, vilka utgör underlag för resultatet i översikten. Resultat: Med stöd i Katie Erikssons vårdteori identifierades tre huvudkategorier av upplevelser, vilka var vårdlidande, sjukdomslidande och livslidande. Varje kategori hade tillhörande underkategorier där patienternas upplevelser beskrivs. Diskussion: Huvudfynd i resultatet har diskuterats utifrån bakgrund, annan forskning och Katie Erikssons vårdteori. Kommunikation och information från vårdpersonalen efter en vårdskada upplevs av patienter bristfällig. I de fall då kommunikation och information upplevs tillfredställande minskar också vårdlidandet. Patienters upplevelser visar att vårdpersonal inte följer sitt ansvar och befintliga lagar, vilket tycks utgöra ett problem som hämmar kvalitet och säkerhet i vården. I kontrast till de negativa upplevelserna förekommer också positiva upplevelser vilka relateras till god vård innan och efter vårdskadan. / Background: Adverse events are common in Swedish and foreign healthcare. These events overall contribute to several days of prolonged hospital stay and occupies a large number of hospital beds. It occupies resources and costs the society billions of Swedish crowns (SEK) every year. Healthcare professionals are responsible for the patients’ safety in the healthcare, which in Sweden is regulated by laws and regulations. These are designed to protect patients against adverse events and injuries in the healthcare and entail obligations for healthcare professionals to constantly work to develop the quality and safety for the patients in the healthcare.  Aim: The aim of this literature review was to describe patients´ experiences of being affected by an adverse event. Method: A literature review has been performed according to Friberg’s method. The databases CINAHL Complete and PubMed were used for searching articles for this literature review. Eleven original articles were found, which are used to form the results of this review. Results: With support in Katie Eriksson´s theory of caring, three main categories of patients experiences were found, these categories were suffering related to healthcare, suffering from illness, suffering of life. Each category had related subcategories where patients' experiences are described. Discussion: Main findings has been discussed on the basis of the background, other research and Katie Eriksson’s theory of caring. A lack of communication and information from the healthcare professionals after an adverse event was experienced. In cases when the communication and information perceived satisfactorily the suffer were reduced. Patients’ experiences show that healthcare professionals do not follow their responsibilities and the existing laws, which inhibits the quality and safety of the healthcare. In contrast to the negative experiences there were also positive experiences, which are related to good care before and after the adverse event.

Pain assessment and management is a fundamental part of nursing care. Opioids are 1 of the interventions utilized to manage pain within the hospital setting and have a known adverse effect called opioid-induced sedation and respiratory depression (OSRD). The purpose of this quantitative study was to create a prediction model with the known risk factors present on admission, to determine how well they predict OSRD. This served as a first step in the creation of a risk screen tool, supported by the cognitive continuum theory, in understanding the judgment and decision-making process to provide safe care. The combination of factors that most accurately predicted the risk of OSRD in patients on admission to an acute care healthcare institution was determined through a retrospective case control analysis. Risk factors present on admission of a case group of 100 patients who had succumbed to OSRD after an opioid administration were matched and compared to a control group of 100 who did not. A binary logistic regression analysis was used to determine how well age, body mass index, obstructive sleep apnea, pulmonary disease, respiratory disease, renal failure, and no opioid use (i.e., being opioid na�ve) predicted OSRD. The presence of pulmonary disease, renal disease, cardiac disease, diabetes, and being opioid na�ve most accurately predicted OSRD. Although only pulmonary disease and renal disease were statistically significant, the final model included other factors that increase the odds of OSRD, which are encompassed in the proposed tool for future research. Through understanding the factors that predict OSRD, a screening tool was created that could save lives in hospital institutions and lead to positive social change by supporting clinical decision making and care.

I den svenska vården drabbas uppskattningsvis var tionde patient av en vårdskada, det vill säga en undvikbar skada direkt orsakad av vården (Socialstyrelsen, 2008; Ödegård, 2007). Vårdskador ska registreras som avvikelser som sedan ska analyseras för att finna orsak och ligga till grund för förbättringsarbete (Socialstyrelsen, 2008). Syftet med studien är att beskriva innehållet i de patientavvikelser som registrerats av personal på sjukhus. Innehållet beskrivs avseende vilka händelser som registrerats och vårdpersonalens beskrivningar av händelseförloppet. Studien innehåller både kvalitativa och kvantitativa delar. Den kvalitativa delen genomfördes med innehållsanalys enligt Graneheim och Lundman (2004). Den kvantitativa delen redovisas med hjälp av deskriptiv statistik. Resultatet av studien visar att de flesta avvikelser berör Organisation/regler/resurser, Vård och behandling samt Halk/fall. Patienter i åldern 70-90 år drabbas i störst utsträckning. Händelseförloppet är ofta detaljerat beskrivet. Personal är däremot mindre benägen att skriva vad de anser vara orsak till det inträffade, samt bidra med förbättringsförslag. Teman som kom ur den kvalitativa analysen var: ”Det blir arbetsamt när andra gör fel”, ”Att vara nära men inte inpå” och ”Att lindra lidande”.