There are 353 NHS hospitals in the United Kingdom, and within these hospitals there is wide variation in the electronic prescribing systems applied. Indeed, only one hospital uses a single system in all of its clinical areas. Medication error is the biggest issue in the health care profession in respect to patient safety—

Introduction :Les anticoagulants oraux soulèvent des problématiques majeures en termes de risque hémorragique et de bon usage. L’informatisation du dossier médical offre la possibilité d’accéder à de grandes bases de données que l’on peut exploiter de manière automatisée. L’objectif de ce travail est de montrer comment la réutilisation de données peut permettre d’étudier des problématiques liées aux anticoagulants et accompagner une démarche d’assurance de la qualité des soins. MéthodesCe travail a été réalisé sur les données informatisées (97 355 séjours) d’un centre hospitalier général. Pour chaque séjour nous disposons des données diagnostiques, biologiques, médicamenteuses, administratives et des courriers de sortie. Ce travail est organisé autour de 3 axes :Axe I. L’objectif est d’évaluer la qualité de la détection des facteurs pouvant majorer l’effet anticoagulant des antivitamines K (AVK), à l’aide de règles développées au cours de du projet européen PSIP (convention de subvention n° 216130). Une revue des cas sur une année a permis de calculer la valeur prédictive positive et la sensibilité des règles. Axe II. Nous avons réalisé une étude de cohorte historique sur les données de 2007 à 2012 pour déterminer les éléments majeurs impliqués dans l’élévation du risque hémorragique sous AVK dans la réalité clinique. Les cas étaient les séjours présentant une élévation de l’INR au-delà de 5, les témoins n’en présentaient pas. Axe III. Nous avons mis la réutilisation de données au service de l’étude de la qualité des prescriptions. D’une part nous avons évalué le suivi des recommandations de traitement du risque thromboembolique dans la fibrillation atriale (FA) chez la personne âgée, d’autre part nous avons étudié les modalités de prescription des anticoagulants oraux directs (AOD).Résultats : Axe I : La valeur prédictive positive des règles de détection des facteurs favorisant l’élévation de l’INR sous AVK est de 22,4%, leur sensibilité est de 84,6%. Les règles les plus contributives sont les règles de détection d’un syndrome infectieux et de l’administration d’amiodarone. Axe II : Les facteurs majeurs d’élévation du risque hémorragique sous AVK mis en évidence par l’étude de cohorte sont le syndrome infectieux, le cancer, l’hyprotidémie et l’insuffisance hépatique. Axe III : Le taux de suivi des recommandations dans la fibrillation atriale chez le sujet âgé est de 47.8%. Seuls 45% des patients reçoivent des anticoagulants oraux, 22,9% ne reçoivent aucun traitement antithrombotique et 32,1% reçoivent des antiagrégants plaquettaires. Les AOD sont quant à eux prescrits à des posologies inadaptées chez 15 à 31,4% des patients, respectivement pour le dabigatran et le rivaroxaban. Ces erreurs sont principalement des sous-dosages en AOD dans la FA de la personne âgée (82.6%). Discussion : L’informatisation des dossiers médicaux a permis la constitution de grandes bases de données médico-administratives, qui peuvent être utilisées à des fins variées comme nous le montrons dans ce travail. Dans le premier axe nous avons montré que des systèmes d’aide à la décision à base de règles permettent de caractériser les facteurs impliqués dans les surdosages en AVK avec une bonne sensibilité mais avec une faible valeur prédictive positive. Le second axe a montré que l’on pouvait utiliser ces données à des fins exploratoires pour identifier les facteurs liés à l’élévation de l’INR chez les patients recevant des AVK en pratique réelle. Le troisième axe montre que les systèmes à base de règles peuvent aussi être utilisés pour identifier des prescriptions inappropriées à des fins d’amélioration de la qualité des soins. Dans le domaine de l’anticoagulation ce travail ouvre des perspectives innovantes en vue de l’amélioration de la qualité des soins. / Introduction :Oral anticoagulants raise major issues in terms of bleeding risk and appropriate use. The computerization of medical records offers the ability to access large databases that can be explored automatically. The objective of this work is to show how routinely collected data can be reused to study issues related to anticoagulants in a supportive approach to quality of care.MethodsThis work was carried out on the electronic data (97,355 records) of a community hospital. For each inpatient stay we have diagnostic, biological, drug and administrative data, and the discharge letters. This work is organized around three axes:Axis I. The objective is to evaluate the accuracy of the detection of factors that may increase the anticoagulant effect of vitamin K antagonists (VKA), using rules developed in the PSIP european project (grant agreement N° 216130). A case review on one year enabled the calculation of the positive predictive value and sensitivity of the rules. Axis II. We conducted a cohort study on data from 2007 to 2012 to determine the major elements involved in raising the risk of bleeding related to VKA in clinical reality. Cases were the stays with an elevation of the INR beyond 5, the controls did not have.Axis III. We made data reuse serve a study of the quality of the prescriptions. On the one hand we assessed treatment of the thromboembolic risk recommendations in atrial fibrillation (AF) in the elderly, on the other hand we investigated the prescription of direct oral anticoagulants.Results : Axis I : The positive predictive value of the rules intended to detect the factors favoring the elevation of INR in case of treatment with VKA is 22.4%, the sensitivity is 84.6%. The main contributive rules are the ones intended to detect an infectious syndrome and amiodarone.Axis II : The major factor increasing the INR with VKA treatment highlighted by the cohort study are infectious syndrome, cancer, hepatic insufficiency and hypoprotidemia. The recommendations compliance rate in atrial fibrillation in the elderly is 47.8%. Only 45% of patients receive oral anticoagulants, 22.9% do not receive antithrombotic treatment at all and 32.1% received platelet aggregation inhibitors. Direct oral anticoagulants are prescribed at inadequate dosages in 15 to 31.4% of patients, respectively for dabigatran and rivaroxaban. These errors are mainly underdosages in the elderly with atrial fibrillation (82.6%).Discussion : The computerization of medical records has led to the creation of large medical databases, which can be used for various purposes as we show in this work. In the first work axis we have shown that rule-based decision support systems detect the contributing factors for VKA overdose with a good sensitivity but a low positive predictive value. The second line shows that we could use the data for exploratory purposes to identify factors associated with increased INR in patients receiving VKA in “real life practice”. The third line shows that the rule-based systems can also be used to identify inappropriate prescribing for the purpose of improving the quality of care. In the field of anticoagulation this work opens up innovative perspectives for improving the quality of care.

Introdução: o aumento da cobertura vacinal reduziu a incidência das doenças imunopreveníveis, elevando os casos de Evento Adverso Pós-Vacinação e Erro de imunização. Objetivo: analisar os erros de imunização e a percepção de vacinadores sobre os fatores que contribuem para a sua ocorrência. Método: abordagem mista, desenvolvida em duas fases: primeira, quantitativa, descritiva, documental, retrospectiva, no período de 2003 a 2013. Utilizados dados secundários do Brasil e primários e secundários do Paraná Sistema de Informação de Eventos Adversos Pós-Vacinação e relatório de erros de imunização do Programa de Imunização. A segunda, qualitativa, exploratória, prospectiva, tendo como referencial a Teoria do Erro Humano, realizada com vacinadores da Região Metropolitana de Curitiba que notificaram erro de imunização em 2013. Classificação do erro de imunização: com evento adverso e sem evento adverso. Para o cálculo das taxas de incidência de erro e diagrama de dispersão, foi utilizado o software SPSS versão 23.0 ajustados pelo Modelo de Regressão Linear Simples. Na fase II, os dados foram coletados por meio de entrevistas e observação não participante, analisados segundo Bardin, utilizando o Web Qualitative Data Analysis WebQDA. Resultados: de 2003 a 2013, no Brasil e no Paraná, o abscesso subcutâneo quente foi o erro de imunização com evento adverso mais frequente. Os menores de um ano foram os mais atingidos pelos erros e a BCG teve taxa de incidência mais elevada. A incidência do erro de imunização com evento adverso aumentou ao longo do período, enquanto o sem evento adverso, elevou-se expressivamente em 2012. A análise da tendência no Paraná de 2003 a 2018, revelou crescimento anual, com elevação contínua da incidência, para ambos, mostrando ainda que a elevação dos percentuais e taxas ocorreu nas campanhas de vacinação, introdução de novas vacinas e mudanças no Calendário Nacional de Vacinação. Nas observações das 26 salas de vacinação, identificou-se: refrigerador não exclusivo, falhas na higienização das mãos (78%), não abordagem sobre possíveis contraindicações ou adiamento da vacinação. Foram entrevistados 115 vacinadores, 96% mulheres, 42% entre 30 a 39 anos, 54% com nível médio de escolaridade e 53% formados há cinco anos ou mais. Atuavam na sala de vacinação entre 3 a 11 anos, 71% realizavam atividades concomitantes em outros setores e 76% não tinham outro emprego. A entrevista revelou que 47% dos vacinadores tinham conhecimento de erro de imunização no seu trabalho, 8,7% estiveram envolvidos em erros e 1,7% referiram haver subnotificação. Dos discursos dos vacinadores emergiram três categorias analíticas: fatores humanos (57,3%), institucionais/organizacionais (34%) e ambientais (8,7%). Das categorias empíricas, destacou-se fatores psicológicos (43,2%) e das subcategorias: distração (21,4%) e estresse (20,9%). Conclusões: o erro de imunização é causado pela interação de múltiplos fatores. Mantendo-se os cenários, as incidências de erro de imunização, com ou sem evento adverso, tendem a continuar ascendentes até 2018. Campanhas, novas vacinas e mudanças no calendário de vacinação aumentam o risco de erro de imunização. Na visão dos vacinadores, a ocorrência de erro de imunização está relacionada, principalmente, a fatores psicológicos e gestão de pessoas. A maioria dos erros de imunização é potencialmente prevenível, desde que a sua ocorrência e causas sejam identificadas. / Introduction: the increase in vaccination coverage reduced the incidence of vaccine-preventable diseases, increasing the number of cases of Adverse Events Following Vaccination and Immunization Error. Objective: to analyze the immunization errors and the perception of vaccinators on the factors that contribute to their occurrence. Method: mixed approach, developed in two phases: the first being quantitative, descriptive, documentary, retrospective, in the period from 2003 to 2013. Secondary data from Brazil and primary data from Paraná were used Surveillance System of Adverse Events Following Vaccination and immunization error reports of the Immunization Program. The second, qualitative, exploratory, prospective phase had as reference the Theory of Human Error, performed with vaccinators of the Metropolitan Region of Curitiba who reported immunization errors in 2013. Classification of immunization error: with and without adverse event. For the calculation of the incidence rates of error and dispersion diagram, the SPSS software version 23.0 was used, adjusted through the Simple Linear Regression Model. In phase II, the data were collected through interviews and non-participant observation, analyzed according to Bardin, using the Web Qualitative Data Analysis WebQDA software. Results: from 2003 to 2013, in Brazil and Paraná, warm subcutaneous abscess was the most frequent immunization error with adverse event. Children under one year old were the most affected by the errors and BCG had higher incidence rate. The incidence of immunization error with adverse event increased over the period, while its incidence without adverse event increased significantly in 2012. The analysis of the trend in Paraná from 2003 to 2018 showed annual growth, with continuous increase in incidence, for both, also showing that the increase of the percentages and rates occurred during the vaccination campaigns, introduction of new vaccines and changes in the National Vaccination Calendar. During the observation of the 26 vaccination rooms, the following were identified: non-exclusive cooler, failures in the sanitation of hands (78%), no addressing of the possible contraindications or postponement of vaccination. 115 vaccinators were interviewed, 96% women, 42% between 30 and 39 years of age, 54% with average level of education and 53% graduated for five years or more. They had been working in the vaccination room for 3 to 11 years, 71% performed concomitant activities in other sectors and 76% did not have another job. The interview revealed that 47% of vaccinators were aware of immunization errors in their work, 8.7% were involved in errors and 1.7% declared there being underreporting. The speeches of the vaccinators resulted in three analytical categories: human (57.3%), institutional/organizational (34%) and environmental (8.7%) factors. Those which stood out, of the empirical categories, were the psychological factors (43.2%), and of the subcategories, distraction (21.4%) and stress (20.9%). Immunization error is caused by the interaction between multiple factors. Conclusions: if kept constant, the scenarios and incidence of immunization errors, with or without adverse event, tend to continue increasing up to 2018. Campaigns, new vaccines and changes in the vaccination calendar increase the risk of immunization error. For the vaccinators, the occurrence of immunization error is related mainly to psychological factors and people management. Most immunization errors are potentially preventable, provided their occurrence and causes are identified.

Objetivo: Este estudo objetivou avaliar a precisão de infusões de medicamentos em dois modelos de Bomba de Infusão (BI), de equipo específico do fabricante e de equipo universal, a concordância entre estes dois modelos e sua relação de custo e efetividade. Método: Foi realizado um ensaio clínico randomizado em pacientes internados em um hospital geral universitário de 740 leitos. As unidades de internação foram randomizadas através de sorteio simples para cada modelo de equipamento e os pacientes foram incluídos de acordo com indicação de uso de BI, conforme protocolo institucional. Os tipos de erros e reações adversas foram classificados por meio de algoritmos. Foi calculado o custo de cada sistema de bomba de infusão, pela vida útil da tecnologia. Resultados: Em 55 pacientes foram acompanhadas 310 infusões, 117 no grupo da bomba de infusão de equipo universal e 193 na bomba de infusão de equipo especifico. Houve semelhança (p=0,40) entre o tempo programado e o observado nas infusões por meio da bomba de equipo específico (-2,1 ± 19 min) e universal (0,08 ± 23 min). Percentualmente, também não foi observada diferença (p=0,70) entre a infusão por bomba de equipo específico (-0,15±3,8%) e universal (0,1±6,3%). Foram observados 14 (4,5%) erros de medicação, semelhantes (p=0,58) entre os tipos de BI. Os custos cumulativos entre os dois sistemas de bombas se equivaleram em 30 meses, sendo que após 11 anos, foram significativamente maiores para bomba de equipo específico em 184,29%. Conclusão: Ambos modelos de BI avaliadas mostraram-se igualmente seguras para administração EV de fármacos, sendo o modelo de equipo universal mais vantajoso economicamente ao longo da vida útil dos equipamentos. / Objective: This study aimed to evaluate the accuracy of drug infusion in two models of infusion pumps (IP), one with a specific IV set and other with universal IV set, the correlation between these two models and their relation of cost and effectiveness. Method: A randomized clinical trial was conducted in hospitalized patients in a university general hospital of 740 beds. The ward units were randomly chosen for each type of equipment, and patients were included according to indication for use of IP, based on institutional protocol. The types of errors and adverse reactions were classified by means of algorithms. The costs of each system for IP, was calculated considering the useful life of the technology. Results: 310 infusions were monitored: 117 in the universal infusion pump group and 193 in the specific equipment group, in 55 patients. The average difference between the scheduled time and the actual one in the infusions was -2.1 ± 19 min. and 0.08 ± 23 min. (p = 0.40) for the universal equipment and specific equipment, respectively, which means an average error of -0.15% ± 3.8% for the universal equipment and 0.10% ± 6.3% for the specific equipment, with no difference between the two types of pump. Fourteen (4.5%) medication errors were observed during the administration of medication, similar between the two types of IP. The cumulative costs between the two pump systems were equivalent in 30 months, and after 11 years the costs were meaningfully higher for the specific equipment pumps in 184,29 %. Conclusion: The infusion pumps do not show meaningful difference in accuracy between scheduled time and the actual one qualifying them as safe for the drugs observed. Cumulative costs were significantly distinct between both pieces of equipment.

The overall aim of this thesis was to evaluate clinical pharmacist interventions with the focus on methods aiming to improve the quality of drug therapy and increase patient safety. Adverse drug events caused by medication errors, suboptimal dosages and inappropriate prescribing are common causes of drug-related morbidity and mortality. Clinical pharmacists integrated in multi-professional health-care teams are increasingly addressing these issues. A randomised controlled trial (RCT) was conducted to investigate the effectiveness of clinical pharmacists’ interventions in reducing morbidity and use of hospital care for patients 80 years or older. The results showed that the intervention group had fewer visits to hospital and that the intervention was cost-effective. In a subsequent study based on the population in the RCT, the appropriateness of prescribing was assessed using three validated tools. The results indicated improved appropriateness of prescribing for the intervention group as a result of the intervention. The tools and the number of drugs at discharge were then tested for validity in terms of causal links between the scores at discharge and hospitalisation. No clear correlations between high scores for the tools or a high number of drugs and increased risk of hospitalisation could be detected. During the inclusion period of the RCT a survey based study was conducted where the perceived value of ward-based clinical pharmacists, from the perspective of hospital-based physicians and nurses as well as from general practitioners (GPs) was evaluated. The respondents were positive to the new collaboration to a high degree and stated increased patient safety and improvements in patients’ drug therapy as the main advantages. In the last study the frequency and severity of prescription and transcription errors, when patients enrolled in the multidose-dispensed medications (MDD) system are discharged from hospital, was investigated. The results showed that errors frequently occur when MDD patients are hospitalised.

Background: The acronym LASA (look-alike sound-alike) denotes the problem of confusing similar- looking and/or sounding drugs accidentally. The most common causes of medication error jeopardizing patient safety are LASA as well as high workload. Case presentation: A critical incident report of medication errors of opioids for postoperative analgesia by lookalike packaging highlights the LASA aspects in everyday scenarios. A change to a generic brand of medication saved costs of up to 16% per annum. Consequently, confusion of medication incidents occurred due to the similar appearance of the newly introduced generic opioid. Due to consecutive underdosing no life-threatening situation arose out of this LASA based medication error. Conclusion: Current recommendations for the prevention of LASA are quite extensive; still, in a system with a lump sum payment per case not all of these security measures may be feasible. This issue remains to be approached on an individual basis, taking into consideration local set ups as well as financial issues.

Objetivo: Este estudo objetivou avaliar a precisão de infusões de medicamentos em dois modelos de Bomba de Infusão (BI), de equipo específico do fabricante e de equipo universal, a concordância entre estes dois modelos e sua relação de custo e efetividade. Método: Foi realizado um ensaio clínico randomizado em pacientes internados em um hospital geral universitário de 740 leitos. As unidades de internação foram randomizadas através de sorteio simples para cada modelo de equipamento e os pacientes foram incluídos de acordo com indicação de uso de BI, conforme protocolo institucional. Os tipos de erros e reações adversas foram classificados por meio de algoritmos. Foi calculado o custo de cada sistema de bomba de infusão, pela vida útil da tecnologia. Resultados: Em 55 pacientes foram acompanhadas 310 infusões, 117 no grupo da bomba de infusão de equipo universal e 193 na bomba de infusão de equipo especifico. Houve semelhança (p=0,40) entre o tempo programado e o observado nas infusões por meio da bomba de equipo específico (-2,1 ± 19 min) e universal (0,08 ± 23 min). Percentualmente, também não foi observada diferença (p=0,70) entre a infusão por bomba de equipo específico (-0,15±3,8%) e universal (0,1±6,3%). Foram observados 14 (4,5%) erros de medicação, semelhantes (p=0,58) entre os tipos de BI. Os custos cumulativos entre os dois sistemas de bombas se equivaleram em 30 meses, sendo que após 11 anos, foram significativamente maiores para bomba de equipo específico em 184,29%. Conclusão: Ambos modelos de BI avaliadas mostraram-se igualmente seguras para administração EV de fármacos, sendo o modelo de equipo universal mais vantajoso economicamente ao longo da vida útil dos equipamentos. / Objective: This study aimed to evaluate the accuracy of drug infusion in two models of infusion pumps (IP), one with a specific IV set and other with universal IV set, the correlation between these two models and their relation of cost and effectiveness. Method: A randomized clinical trial was conducted in hospitalized patients in a university general hospital of 740 beds. The ward units were randomly chosen for each type of equipment, and patients were included according to indication for use of IP, based on institutional protocol. The types of errors and adverse reactions were classified by means of algorithms. The costs of each system for IP, was calculated considering the useful life of the technology. Results: 310 infusions were monitored: 117 in the universal infusion pump group and 193 in the specific equipment group, in 55 patients. The average difference between the scheduled time and the actual one in the infusions was -2.1 ± 19 min. and 0.08 ± 23 min. (p = 0.40) for the universal equipment and specific equipment, respectively, which means an average error of -0.15% ± 3.8% for the universal equipment and 0.10% ± 6.3% for the specific equipment, with no difference between the two types of pump. Fourteen (4.5%) medication errors were observed during the administration of medication, similar between the two types of IP. The cumulative costs between the two pump systems were equivalent in 30 months, and after 11 years the costs were meaningfully higher for the specific equipment pumps in 184,29 %. Conclusion: The infusion pumps do not show meaningful difference in accuracy between scheduled time and the actual one qualifying them as safe for the drugs observed. Cumulative costs were significantly distinct between both pieces of equipment.

Objetivo: Este estudo objetivou avaliar a precisão de infusões de medicamentos em dois modelos de Bomba de Infusão (BI), de equipo específico do fabricante e de equipo universal, a concordância entre estes dois modelos e sua relação de custo e efetividade. Método: Foi realizado um ensaio clínico randomizado em pacientes internados em um hospital geral universitário de 740 leitos. As unidades de internação foram randomizadas através de sorteio simples para cada modelo de equipamento e os pacientes foram incluídos de acordo com indicação de uso de BI, conforme protocolo institucional. Os tipos de erros e reações adversas foram classificados por meio de algoritmos. Foi calculado o custo de cada sistema de bomba de infusão, pela vida útil da tecnologia. Resultados: Em 55 pacientes foram acompanhadas 310 infusões, 117 no grupo da bomba de infusão de equipo universal e 193 na bomba de infusão de equipo especifico. Houve semelhança (p=0,40) entre o tempo programado e o observado nas infusões por meio da bomba de equipo específico (-2,1 ± 19 min) e universal (0,08 ± 23 min). Percentualmente, também não foi observada diferença (p=0,70) entre a infusão por bomba de equipo específico (-0,15±3,8%) e universal (0,1±6,3%). Foram observados 14 (4,5%) erros de medicação, semelhantes (p=0,58) entre os tipos de BI. Os custos cumulativos entre os dois sistemas de bombas se equivaleram em 30 meses, sendo que após 11 anos, foram significativamente maiores para bomba de equipo específico em 184,29%. Conclusão: Ambos modelos de BI avaliadas mostraram-se igualmente seguras para administração EV de fármacos, sendo o modelo de equipo universal mais vantajoso economicamente ao longo da vida útil dos equipamentos. / Objective: This study aimed to evaluate the accuracy of drug infusion in two models of infusion pumps (IP), one with a specific IV set and other with universal IV set, the correlation between these two models and their relation of cost and effectiveness. Method: A randomized clinical trial was conducted in hospitalized patients in a university general hospital of 740 beds. The ward units were randomly chosen for each type of equipment, and patients were included according to indication for use of IP, based on institutional protocol. The types of errors and adverse reactions were classified by means of algorithms. The costs of each system for IP, was calculated considering the useful life of the technology. Results: 310 infusions were monitored: 117 in the universal infusion pump group and 193 in the specific equipment group, in 55 patients. The average difference between the scheduled time and the actual one in the infusions was -2.1 ± 19 min. and 0.08 ± 23 min. (p = 0.40) for the universal equipment and specific equipment, respectively, which means an average error of -0.15% ± 3.8% for the universal equipment and 0.10% ± 6.3% for the specific equipment, with no difference between the two types of pump. Fourteen (4.5%) medication errors were observed during the administration of medication, similar between the two types of IP. The cumulative costs between the two pump systems were equivalent in 30 months, and after 11 years the costs were meaningfully higher for the specific equipment pumps in 184,29 %. Conclusion: The infusion pumps do not show meaningful difference in accuracy between scheduled time and the actual one qualifying them as safe for the drugs observed. Cumulative costs were significantly distinct between both pieces of equipment.

Introdução: o aumento da cobertura vacinal reduziu a incidência das doenças imunopreveníveis, elevando os casos de Evento Adverso Pós-Vacinação e Erro de imunização. Objetivo: analisar os erros de imunização e a percepção de vacinadores sobre os fatores que contribuem para a sua ocorrência. Método: abordagem mista, desenvolvida em duas fases: primeira, quantitativa, descritiva, documental, retrospectiva, no período de 2003 a 2013. Utilizados dados secundários do Brasil e primários e secundários do Paraná Sistema de Informação de Eventos Adversos Pós-Vacinação e relatório de erros de imunização do Programa de Imunização. A segunda, qualitativa, exploratória, prospectiva, tendo como referencial a Teoria do Erro Humano, realizada com vacinadores da Região Metropolitana de Curitiba que notificaram erro de imunização em 2013. Classificação do erro de imunização: com evento adverso e sem evento adverso. Para o cálculo das taxas de incidência de erro e diagrama de dispersão, foi utilizado o software SPSS versão 23.0 ajustados pelo Modelo de Regressão Linear Simples. Na fase II, os dados foram coletados por meio de entrevistas e observação não participante, analisados segundo Bardin, utilizando o Web Qualitative Data Analysis WebQDA. Resultados: de 2003 a 2013, no Brasil e no Paraná, o abscesso subcutâneo quente foi o erro de imunização com evento adverso mais frequente. Os menores de um ano foram os mais atingidos pelos erros e a BCG teve taxa de incidência mais elevada. A incidência do erro de imunização com evento adverso aumentou ao longo do período, enquanto o sem evento adverso, elevou-se expressivamente em 2012. A análise da tendência no Paraná de 2003 a 2018, revelou crescimento anual, com elevação contínua da incidência, para ambos, mostrando ainda que a elevação dos percentuais e taxas ocorreu nas campanhas de vacinação, introdução de novas vacinas e mudanças no Calendário Nacional de Vacinação. Nas observações das 26 salas de vacinação, identificou-se: refrigerador não exclusivo, falhas na higienização das mãos (78%), não abordagem sobre possíveis contraindicações ou adiamento da vacinação. Foram entrevistados 115 vacinadores, 96% mulheres, 42% entre 30 a 39 anos, 54% com nível médio de escolaridade e 53% formados há cinco anos ou mais. Atuavam na sala de vacinação entre 3 a 11 anos, 71% realizavam atividades concomitantes em outros setores e 76% não tinham outro emprego. A entrevista revelou que 47% dos vacinadores tinham conhecimento de erro de imunização no seu trabalho, 8,7% estiveram envolvidos em erros e 1,7% referiram haver subnotificação. Dos discursos dos vacinadores emergiram três categorias analíticas: fatores humanos (57,3%), institucionais/organizacionais (34%) e ambientais (8,7%). Das categorias empíricas, destacou-se fatores psicológicos (43,2%) e das subcategorias: distração (21,4%) e estresse (20,9%). Conclusões: o erro de imunização é causado pela interação de múltiplos fatores. Mantendo-se os cenários, as incidências de erro de imunização, com ou sem evento adverso, tendem a continuar ascendentes até 2018. Campanhas, novas vacinas e mudanças no calendário de vacinação aumentam o risco de erro de imunização. Na visão dos vacinadores, a ocorrência de erro de imunização está relacionada, principalmente, a fatores psicológicos e gestão de pessoas. A maioria dos erros de imunização é potencialmente prevenível, desde que a sua ocorrência e causas sejam identificadas. / Introduction: the increase in vaccination coverage reduced the incidence of vaccine-preventable diseases, increasing the number of cases of Adverse Events Following Vaccination and Immunization Error. Objective: to analyze the immunization errors and the perception of vaccinators on the factors that contribute to their occurrence. Method: mixed approach, developed in two phases: the first being quantitative, descriptive, documentary, retrospective, in the period from 2003 to 2013. Secondary data from Brazil and primary data from Paraná were used Surveillance System of Adverse Events Following Vaccination and immunization error reports of the Immunization Program. The second, qualitative, exploratory, prospective phase had as reference the Theory of Human Error, performed with vaccinators of the Metropolitan Region of Curitiba who reported immunization errors in 2013. Classification of immunization error: with and without adverse event. For the calculation of the incidence rates of error and dispersion diagram, the SPSS software version 23.0 was used, adjusted through the Simple Linear Regression Model. In phase II, the data were collected through interviews and non-participant observation, analyzed according to Bardin, using the Web Qualitative Data Analysis WebQDA software. Results: from 2003 to 2013, in Brazil and Paraná, warm subcutaneous abscess was the most frequent immunization error with adverse event. Children under one year old were the most affected by the errors and BCG had higher incidence rate. The incidence of immunization error with adverse event increased over the period, while its incidence without adverse event increased significantly in 2012. The analysis of the trend in Paraná from 2003 to 2018 showed annual growth, with continuous increase in incidence, for both, also showing that the increase of the percentages and rates occurred during the vaccination campaigns, introduction of new vaccines and changes in the National Vaccination Calendar. During the observation of the 26 vaccination rooms, the following were identified: non-exclusive cooler, failures in the sanitation of hands (78%), no addressing of the possible contraindications or postponement of vaccination. 115 vaccinators were interviewed, 96% women, 42% between 30 and 39 years of age, 54% with average level of education and 53% graduated for five years or more. They had been working in the vaccination room for 3 to 11 years, 71% performed concomitant activities in other sectors and 76% did not have another job. The interview revealed that 47% of vaccinators were aware of immunization errors in their work, 8.7% were involved in errors and 1.7% declared there being underreporting. The speeches of the vaccinators resulted in three analytical categories: human (57.3%), institutional/organizational (34%) and environmental (8.7%) factors. Those which stood out, of the empirical categories, were the psychological factors (43.2%), and of the subcategories, distraction (21.4%) and stress (20.9%). Immunization error is caused by the interaction between multiple factors. Conclusions: if kept constant, the scenarios and incidence of immunization errors, with or without adverse event, tend to continue increasing up to 2018. Campaigns, new vaccines and changes in the vaccination calendar increase the risk of immunization error. For the vaccinators, the occurrence of immunization error is related mainly to psychological factors and people management. Most immunization errors are potentially preventable, provided their occurrence and causes are identified.

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES / INTRODUCTION. Adverse events have been the focus of studies in various countries, because they occur frequently and increase the morbidity and mortality of patients, constituting a new public health problem, directly impacting on patient safety. High alert medication (HAM) are more predictable to cause significant harm to the patient, even when used as intended. Other authors claim that the damage related to the HAM's lead not only suffering to the patient, but also raise the additional costs associated with care. OBJECTIVE. Evaluate the safety profile of HAM. METHODOLOGY. It was conducted active search for information through COCHRANE databases, LILACS, SciELO, SCOPUS, PubMed / MEDLINE and WEB OF SCIENCE. Then two reviewers independently conducted a preliminary evaluation of relevant titles, abstracts and then finally full text. RESULTS The initial search in the databases identified 1717 articles, which after exclusion of repeated work identified 427 titles, of which 53 are considered potentially relevant abstracts were selected. After evaluation of these, 25 were selected to read the full text. The systematic review evaluated seven articles, which showed that only 11 MAV's were identified in the literature could have serious events. The most frequently cited were warfarin (22.2%), cyclophosphamide (22.2%) and cyclosporine (22.2%).CONCLUSIONS. There were no reported any kind of error in the use of AVM's and particularly serious risks are unlikely because of the risks reported in patients related to drug classes involved. According to the criteria of quality, this revision came just seven articles that address the universe of MAV's, achieving high level of evidence only for six of these, which involved only some drugs: morphine, M6G-glicurônio, haloperidol, promethazine, ivabradine , digoxin, warfarin, ximelagatran, cyclophosphamide, cyclosporin and ATG. The review showed that one of the strategies used to improve security in hospitalized patients and use of AVM's is the creation of these medications protocol, and it is important to evaluate among the classes the drug that causes less damage. / INTRODUÇÃO. Os eventos adversos a medicamentos (EAM) têm sido foco de estudos em vários países, pois ocorrem com frequência e aumentam a morbimortalidade dos pacientes, constituindo-se em novo problema de saúde pública, impactando diretamente na segurança dos pacientes. Medicamentos de Alta Vigilância (MAV) são mais comuns de provocar danos significativos ao paciente, mesmo quando utilizados da forma prevista. Outros autores afirmam, que os danos relacionados aos MAV’s levam não só o sofrimento ao paciente, mas também elevam os custos adicionais associados com o cuidado. OBJETIVO. Avaliar o perfil de segurança dos MAV’s. METODOLOGIA. Foi realizado busca ativa de informações por meio das bases de dados COCHRANE, LILACS, SCIELO, SCOPUS, PUBMED/MEDLINE e WEB OF SCIENCE. Em seguida dois revisores de forma independente conduziram a avaliação inicial de títulos relevantes, posteriormente resumos e por fim texto completo. RESULTADOS. A busca inicial nas bases de dados identificou 1717 artigos, que após exclusão dos trabalhos repetidos identificou 427 títulos, dos quais foram selecionados 53 resumos considerados potencialmente relevantes. Após a avaliação destes, 25 foram selecionados para leitura do texto completo. A revisão sistemática avaliou sete artigos, os quais mostraram que apenas 11 MAV’s foram identificados na literatura com potenciais eventos graves. Os mais citados foram a varfarina (22,2%), ciclofosfamida (22,2%) e ciclosporina (22,2%). CONCLUSÕES. Não foram relatados nenhum tipo de erro no uso de MAV’s e notadamente riscos graves são pouco relatados provavelmente por conta da gravidade dos riscos em pacientes que utilizaram as classes medicamentosas envolvidas. De acordo com os critérios de qualidade, a referida revisão chegou a apenas sete artigos que abordam o universo dos MAV’s, conseguindo evidência de grau elevado apenas para seis destes, que envolveram somente alguns medicamentos: morfina, M6G-glicurônio, haloperidol, prometazina, ivabradina, digoxina, varfarina, ximelagatran, ciclofosfamida, ATG e ciclosporina. A revisão mostrou que uma das estratégias utilizadas para melhorar segurança em pacientes internados e em uso de MAV’s é a criação de protocolo de uso desses medicamentos, bem como é importante avaliar dentre as classes o medicamento que cause menos dano.