Evaluation of quality of surgical care begins with the Donabedian triad focusing on structure, process, and outcomes. Outcomes, which are inherently patient-centered, are most easily and commonly measured, and are indeed fundamental to evaluating the quality of surgical care. Specifically, post-operative adverse events (AEs) remain the most frequently measured and reported outcomes, as they represent harm to the patient; and thus, are often used as a means for comparing institutional, as well as, individual surgeon performance. The importance of rigorous recording of clearly defined AEs, although widely recognized, is poorly performed in practice. In previous work, created in accordance to the Clavien-Dindo classification, we developed and integrated a classification of Thoracic Morbidity & Mortality (TM&M) within The Ottawa Hospital’s Division of Thoracic Surgery allowing objective and standardized assessment of all post-operative AEs following all surgeries. In this thesis, the complementary studies that were conducted surrounding the continued clinical application and critical appraisal of the TM&M classification system as a means toward quality improvement are described. Using standardized reporting of both incidence and severity of post-operative complications, we first provide an overview of the burden and distribution that the two most pervasive post-operative AEs have on the thoracic surgical patient population, including prolonged alveolar air leak and atrial fibrillation (Chapter I and II). Next, we explore the inter-system reliability of reported AEs following thoracic surgery from the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP), which is widely considered the most prominent surgical quality improvement effort, and the TM&M classification system in order to better understand to what extent the methods used to collect data may be impacting results (Chapter III). The disparity between the two systems and the duplicate participation indicates distinct value to the two quality reporting systems. An absence of evidence in the literature regarding individual surgeon outcome reporting and its impact on the quality of care prompted us to create risk-adjusted, surgeon-specific outcome reports to enable individualized performance measurement and feedback (Chapter IV). A priority for the division has been to ensure such measurement translates into reproducible improvements in surgical performance. To do so, we implemented complementary continuous quality improvement seminars to provide an additional forum for discussion regarding collective results, utilizing positive deviance, to unmask best performers as a catalyst for discussing practice measures to improve specific AEs. Lastly, an evolutionary understanding of the heterogeneity of TM&M data was considered as a critical next step to following improvements in care (Chapter V). Recognizing that software was necessary to efficiently record and review TM&M data, iterative development led to an evolution of a real-time, web-based, point-of-care Thoracic Surgery Quality monitoring, Information management, and Clinical documentation (TSQIC) software system. The TSQIC system has enabled bedside data recording and storage, and automated dynamic analysis and reporting of surgical volume and quality. We observe that measurement of TM&M data alone, while necessary, is not sufficient for quality improvement. We suggest that in addition to implementing a complementary point-of-care, interactive, web-based quality monitoring system, key factors for improving quality and patient safety include a combination of temporal analyses of AEs, effective surgeon-specific feedback mechanisms, actionable information based on best practice measures, standardization of case reviews, and a unit-based approach conducive of team-work and safety culture, led by open and collegial dialogue.

Analysis of spontaneous adverse events reports of hypolipidemics Author: Anežka Škabradová Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Hypolipidemic drugs are widely used in today's medicine and their consumption is still rising. Besides all benefits, their usage includes also some risks that needs to be reconsidered regularly. Analysis of spontaneous adverse effects (AEs) reports contributes to a safer therapy by detecting especially serious and unexpected adverse drug reactions. Objective: The aim of this thesis was to analyse spontaneous adverse events reports of hypolipidemic drugs, which were sent to the State Institute for Drug Control (SÚKL) database in the period from June 2004 to October 2017. Methods: The data obtained from SÚKL during the above mentioned period was analysed using descriptive statistics. The frequency of occurrence of certain AEs, which were categorized according to MedDRA and distinguished by hypolipidemics, was analysed, as well as their severity and expectability. Part of the analysis was for example also by whom was the report submitted and which way they used to submit it. Results: Overall 290 reports were obtained,...

Analysis of spontaneous adverse events reports of antiepileptic drugs Author: Ivana Šoborová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Epilepsy is one of the most common neurological diseases, which occurs worldwide. Antiepileptic drugs (AED) suppress the onset of an epileptic seizure. Analysis of spontaneous adverse drug reactions (ADRs) analysis is important data source for generating the potential risks signals in pharmacotherapy. Objective: The aim of this work was to analyse spontaneous reports of ADRs from the Czech Central Database of ADRs of the State Institute for Drug Control (SÚKL) in the period from June 2004 to October 2017. The analyses of potential drug interactions of all medicinal products mentioned in the reports and the assessment of the reported ADRs expectability was the secondary goal. Methods: Retrospective analyses of the spontaneous ADR reports of antiepileptic drugs obtained from the SÚKL in the given period. Anonymized data was processed using the descriptive statistics in MS Excel. For example, the patient characteristics or seriousness and expectability of the ADRs were evaluated. The specific adverse drug reactions were divided according to the system...

Background: Root Cause Analysis (RCA) is a method of investigating adverse events (AEs). The purpose of RCA is to improve quality of care and patient safety through a retrospective, structured investigative process of an incident, resulting in recommendations to prevent the recurrence of medical errors. Aim: The aim of the study was to develop and validate a prototype questionnaire to establish whether the RCA model and processes employed at the research setting were perceived by the users to be acceptable, thorough and credible in terms of internationally established criteria. Methods: This is a validation study comprising four phases to meet the study objectives: 1) the development of a prototype questionnaire guided by a literature review; 2) assessing the validity of the content of the questionnaire by and numerical evaluation of the face validity thereof; 3) assessing the qualitative face validity cognitive interviews; and 4) reliability by test-retest. Results: Content validity assessment in Phase 2 resulted in removal of 1/36 (2.77%) question items and amendment of 7/36 (19.44%), resulting in 35 for the revised questionnaire. Analysis of data from the cognitive interviews resulted in amendment of 20/35 (57.14%) question items but no removal. Reliability of the final questionnaire achieved the predetermined ≥0.7 level of agreement. Conclusion: The questionnaire achieved a high content validity index and face validity was enhanced by cognitive interviews by providing qualitative data. The inter-rater coefficient indicated a high level of reliability. The tool was designed for a local private healthcare sector and this may limit its use.

Introduction : Dans la population pédiatrique, la prescription des antipsychotiques (AP) connait une hausse majeure ces quinze dernières années malgré une Autorisation de Mise sur le Marché (AMM) française limitée à quelques molécules AP avec des indications réduites. Cela conduit à un taux de prescription hors AMM important avec des modalités de prescription dépendantes du prescripteur en l’absence de recommandations de prescription et de surveillance. De plus, la littérature relève un nombre inquiétant d’événements indésirables (EI) associé à un manque de données sur les conséquences à moyen et long terme. Méthode : L’étude ETAPE nationale, multicentrique, prospective a été financée par l’Agence Nationale de Sécurité du Médicament et des produits dérivés. L’objectif principal était de déterminer le taux d’incidence des EI au cours d’un suivi de 12 mois chez des enfants et des adolescents de 6 à 18 ans exposés pour la première fois à un AP quel que soit le motif de la prescription. Le suivi proposé était de 12 mois avec 5 visites (à l’inclusion, puis à 3, 6, 9 et 12 mois). Une recherche exhaustive des EI a été réalisée à chaque visite grâce à la passation d’échelles cliniques, un examen physique et des bilans complémentaires. Résultats : L’étude a débuté en Avril 2013, la période d’inclusion s’est étendue sur deux ans et le suivi s’est terminé en Avril 2016. Au total, 200 patients ont été inclus. Les données de 190 patients ont été analysées. L’âge moyen était de 12 ± 2,99 ans, avec une proportion de 75% de garçons. A l’inclusion, 91% des patients ont reçu un AP en monothérapie et 9% au moins deux psychotropes. Rispéridone et aripiprazole étaient les AP les plus prescrits. Parmi les prescriptions d’AP, 20,5% répondaient à une AMM. Parmi les EI potentiellement attribuables à l’AP : 15,4% étaient neuromoteurs, 14,8% gastroentérologiques, 12,2% métaboliques et 11,8% étaient des symptômes généraux. Le taux d’incidence des EI était de 11,52 EI par personne-année (IC 95% [9,83 ; 13,20]). Chez les 108 patients avec un suivi complet de 12 mois, 52,7% des EI sont apparus au cours du premier trimestre d’exposition (représentés principalement par les EI généraux et hormonaux). Néanmoins, l’apparition des EI était observée pendant toute la durée du suivi. Parmi ces patients, 25,8 % ont présenté au moins un EI sévère ou extrêmement sévère. De plus, la présence des EI s’est révélée stable au cours des 12 mois. Conclusion : Ce travail a contribué à mettre en évidence dans une population naïve pédiatrique nationale un fort taux d’incidence d’EI et un taux d’apparition et de présence des EI stable sur 12 mois. La présence d’EI sévères a touché un quart de la population ayant complété le suivi. Perspectives : Sur un échantillon de 55 patients niçois nous chercherons l’impact du polymorphisme génétique des cytochromes dans le métabolisme des AP et sur l’apparition des EI. L’ensemble de ces travaux a pour objectif de contribuer à la mise en place de recommandations de prescription et de surveillance des paramètres cliniques, biologiques et électrocardiographiques lors de l’introduction d’un AP en population pédiatrique pour améliorer la balance bénéfice/risque. / Background In France, as in the rest of the world, the off-label prescription of antipsychotics is on the rise in the pediatric population. In the literature, we noticed a significant lack of data on drug safety and adverse events in the naïve pediatric population treated by antipsychotic in the short as well as in the long term. In addition, studies independent of pharmaceutical laboratories are lacking. Method ETAPE Study was a naturalistic prospective multicenter study conducted between April 2013 and May 2016. Type of AP, concomitant treatment, clinical evaluation and AEs were registered at inclusion and 3-, 6-, 9- and 12-months follow up. This trial is registered with ClinicalTrials.gov, number NCT02007928. The main objective was to determine the incidence rate of adverse events (AEs) in the antipsychotic-naïve pediatric population treated by antipsychotic (AP) during a 12-months. Outcomes A total of 190 patients were analyzed. The mean age was 12 ± 2.99 years, with 75% being males. At baseline, 91% of patients received AP monotherapy and 9% received at least two psychotropic drugs. Risperidone and aripiprazole were the most frequently prescribed AP. 20.5% of prescriptions were in label. Among the AEs potentially attributable to AP, 15.4% were neuromotor, 14.8% gastroenterological, 12.2% metabolic and 11.8% general symptoms. The overall incidence rate was 11.52 AE per person-years (IC 95% [9.83; 13.20]). In patients completing completed FU (n=108), 52.7% of AEs appeared during the first 3 months, but onset of AE was noted during the 12-months FU. 25.8 % of patients have been exposed to at least one severe or extreme severity AE. The persistence of AEs was stable during the 12-months FU.Interpretation The high incidence rate of AEs, the severity and the persistence of AEs justify the necessity of clinical and biological follow-up of AEs during at least 12-months of AP treatment.

No description available.

Estudo quantitativo, descritivo e prospectivo, realizado com o objetivo de analisar os efeitos da alocação de recursos humanos e da carga de trabalho de enfermagem nos resultados da assistência em duas unidades de terapia intensiva (UTIs), uma geral (UTI Geral) e outra cardiovascular (UTI-CV), com 25 leitos cada, de um hospital privado do município de São Paulo. Utilizou-se uma metodologia capaz de abranger 87% da variação dos cuidados requeridos pelos pacientes, composta por itens que incluem a dimensão biológica e psico-social do cuidado: o Patient Focused Solutions/Workload Measurement-Inpatient Methodology (PFS/WM-IM). Foram considerados indicadores de resultado: queda, erro de medicação, extubação não planejada, retirada acidental de cateter venoso central, retirada não programada de sonda nasogástrica, úlcera por pressão (UP), infecção urinária (ITU) e pneumonia desenvolvidas durante a internação hospitalar. Os dados foram obtidos dos prontuários e dos registros da Comissão de Controle de Infecção Hospitalar, além da escala diária de pessoal de enfermagem. Após 46 dias consecutivos de coleta de dados, a amostra final foi composta por 328 pacientes, sendo 166 da UTI Geral e 162 da UTI-CV. Observou-se predomínio de pacientes do gênero masculino (cerca de 56,0% em cada unidade), presença de idosos com 61 anos ou mais (65,1%), na UTI Geral, e entre 41 e 60 anos, na UTI-CV (48,2%), submetidos a tratamento clínico (54,8% na UTI Geral e 79,6% na UTI-CV) e média de internação de 11,0 (±28,0) e 14,2 (±52,9) dias, nas UTIs Geral e CV, respectivamente. A maioria dos pacientes da UTI Geral foi proveniente do centro cirúrgico (41,6%) e da UTI-CV do pronto atendimento (51,9%). Após a alta, proporção semelhante de pacientes das duas Unidades (cerca de 56,0%) foram transferidos para a unidade de internação. A mortalidade observada no período foi de, respectivamente, 9,6% e 14,8% nas UTIs Geral e CV. Com relação à ocorrência de eventos adversos (EAs), na UTI Geral, 20 pacientes (12,0%) sofreram 26 EAs, ou seja, 14 e 6 pacientes foram vítimas de 1 e 2 eventos, respectivamente, sendo 11 retiradas não programadas de sondas nasogástrica, 5 UP, 3 erros de medicação, 2 retiradas acidentais de cateteres venosos central, 2 pneumonias, 2 ITU e 1 extubação não planejada. Na UTI-CV 9 pacientes (5,6%) sofreram 14 EAs, ou seja, 5, 3 e 1 pacientes sofreram 1, 2 e 3 EAs, respectivamente, sendo 5 UP, 4 ITU, 2 erros de medicação, 2 pneumonias, 1 retirada não programada de sonda nasogástrica. Os pacientes foram classificados predominantemente nas categorias 4 e 5 (média e alta complexidade de cuidados de enfermagem). Observou-se, em cada UTI, em média, 1 enfermeiro para 8 pacientes e 1 técnico de enfermagem para, no máximo, 2 pacientes. A média de horas disponíveis de enfermagem foi maior do que o recomendado pelo PFS/WM-IM, respectivamente 15,3 e 13,4h na UTI Geral (p<0,001) e 16,4 e 14,1h na UTI-CV (p<0,001). No período analisado, apesar do excedente de pessoal de enfermagem nas duas UTIs, houve ocorrência de EAs. Os resultados deste estudo se contrapõem, portanto, às solicitações freqüentes de enfermeiros por maior quantidade de pessoal na UTI. No entanto, apontam para a necessidade de novas investigações que confirmem ou refutem os resultados obtidos, com vistas à adequação de pessoal que assegure tanto a qualidade da assistência como a diminuição de custos na UTI / This was a prospective, descriptive an quantitative study, performed with the aim of analyzing the effects of human resources allocation and nursing workload on the assistance results in two intensive care units (ICUs), a General one (General ICU) and Cardiovascular one (CV-ICU) with 25 beds each from a private hospital in the city of São Paulo, Brazil. It was adopted a methodology able to reach 87% of the variation of care required by patients. This methodology was composed by items that include the both the biological and psychosocial dimension concerning care: o Patient Focused Solutions/Workload Measurement-Inpatient Methodology (PFS/WM-IM). It was considered result indicators such as fall, medication errors, unplanned extubation, unplanned withdrawal central venous catheter, unplanned withdrawal nasogastric probe, hospital acquired decubitus ulcer (PU), urinary tract infection (UTI) and pneumonia developed during hospital care. The data were collected from the medical reports and registers of the Commission for Hospital Infection Control, as well as the daily work schedule from the nursing staff. After 46 consecutive days of data collection, the final sample was composed by 328 patients - 166 in the General ICU and 162 in the CV-ICU. It was observed a predominance of male patients (about 56.0% in each unit), the presence of elderly aging 61 or more (65.1%) in the General ICU and 41-60 years in the CV-ICU (48.2%), who had undergone clinical treatment (54.8% in the General ICU and 79.6% in the CV-ICU) and admission average of 11.0 (±28.0) days and 14.2 (+ 52.9) days in the General ICU and CV-ICU respectively. After the discharge, similar proportion of patients from both units (about 56.0%) was transferred to the admission unit. The mortality rate observed in this period was of 9.6% and 14.8% respectively in both units, General ICU and CV-ICU. With relation to the occurrence of adverse events (AEs), in the General ICU, 20 patients (12.0%) suffered 26 AEs, that is, 14 and 6 patients were victims of 1 and 2 events respectively. From these, 13 unplanned withdrawal nasogastric probe, 5 PU, 3 medication errors, 2 unplanned withdrawal central venous catheter, 2 pneumonias, 2 UTI and 1 unplanned extubation). In the CV-ICU, 9 patients (5.6%) suffered 14 AEs, that is, 5, 3 and 1 patients suffered 1, 2 and 3 AEs, respectively being 5 PU, 4 UTI, 2 medication errors, 2 pneumonias, 1 unplanned withdrawal nasogastric probe. The patients were predominantly classified into categories 4 and 5 (medium and high nursing care complexity). It was observed, in each ICU, on an average, 1 nurse for every 8 patients, 1 nurse technician for 2 patients the most. The average nursing hours available were higher than the recommended by the PFS/WM-IM, 15.3 and 13.4 in the General ICU and 16.4 and 14.1 hour in the CV-ICU (p<0,001) respectively. In the period analyzed, despite the exceeding of nursing staff in both General and CV-ICU ICUs, there were AEs. The results of this study meet, therefore, the frequent nurses\' requests for more people in the ICU. However, the also point out the need of further investigations that may either confirm or not such results, aiming at appropriating a number of people who can assure both care quality and costs decrease in ICUs

Casos de profissionais cometendo iatrogenias em relação a erros de medicação, lesões cutâneas em clientes por material cortante, entre outros, mostrados na mídia televisiva, muitas vezes com pessoas em menoridade, como as crianças, em geral causam grande impacto e empatia frente à sociedade. Dentre estes eventos adversos, estão as quedas de pacientes, uma das injúrias mais relatadas dentre as que são englobadas na segurança do paciente. Assim, este estudo objetivou aplicar uma metodologia da revisão integrativa para identificar estudos desenvolvidos sobre o tema quedas e/ ou acidentes por quedas de pacientes em instituição hospitalar. A revisão integrativa contemplou seis etapas, sendo que na quinta etapa (interpretação ou integração dos resultados) foram utilizados sete níveis de evidência para a classificação dos estudos. Foi realizada nas bibliotecas Cochrane e Scientific Electronic Library Online (SciELO) e nas seguintes bases de dados: Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE (Excerpta Medica Database), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), PubMed (US National Library of Medicine National Institutes of Health), Scopus e Web of Science, referente às publicações realizadas dos anos de 2002 a 2012, com os descritores / palavras-chave utilizados que contemplavam os termos quedas, pacientes e hospitais, em diferentes estratégias de busca. A seleção inicial contemplou 33.280 artigos, que após aplicados os critérios de inclusão e exclusão resultaram em uma amostra de 220 artigos. Deste total de artigos, os níveis de evidência baseados nos tipos de estudos, correspondentes ao total de artigos da presente pesquisa, foram o II, III, IV e VI, correspondentes a 10%, 0,9%, 39,1% e 50%, respectivamente. Assim, os estudos descritivos foram os mais presentes; seguido dos de coorte, caso-controle e quase-experimentais; dos ensaios clínicos controlados randomizados; e dos ensaios clínicos bem delineados sem randomização, respectivamente. Pode-se verificar também que os níveis de evidência dos estudos relacionados aos temas características / etiologias / fatores de risco e prevenção de quedas, e condutas pós-quedas acompanharam a mesma sequência daqueles com maior incidência no presente estudo (nível VI) para o de menor incidência (nível III). Os achados referentes às características / etiologias / fatores de risco relacionados a quedas de pacientes hospitalizados foram distribuídos em 14 subtemas, que totalizaram 24 itens, que contemplaram os achados que apresentaram associação com o tema. Em relação às medidas preventivas, encontrou-se 19 achados, dentre eles programas de prevenção de quedas; ferramentas / avaliação de risco de quedas; diretrizes / intervenções; recursos humanos / dinâmica de trabalho; acompanhante / sitter / voluntários; escalas de avaliação da funcionalidade (atividade de vida diária /dependência do cuidado) e função motora; luz de chamada; e cuidados de enfermagem. Somado a isto, das 14 condutas pós-quedas relatadas nos artigos, as mais presentes foram radiografias; administração de medicamentos / analgesia; avaliação médica / especialista; curativo simples / sutura; e observação. Logo, ao se pensar em quedas de pessoas há de ter-se em mente que um corpo desliza ou vai ao chão, devido a uma falta de sustentação do mesmo, decorrente de alguma situação intrínseca ao indivíduo ou devido a fatores externos que contribuem para que a pessoa deixe seu estado de \"equilíbrio postural\". Assim, este estudo proporcionou ter uma visão ampla sobre a diferentes contextos inerentes às quedas de pacientes hospitalizados, a fim de se conseguir desenvolver ações preventivas custo-efetivas e que proporcione uma assistência de qualidade aos indivíduos assistidos em instituições hospitalares / Cases of professionals committing iatrogenic regarding medication errors, cutaneous lesions in customers by cutting material, among others, shown in television media, often with underage people, such as children, in general cause greatly impact and empathy for society. Of these adverse events, patient falls are one of the most reported injuries among which are included in the safety of the patient. Thus, this study aimed to apply an integrative review methodology to identify studies development about the topic of falls and / or accidents from falls of patients in hospital. The integrative review included six stages, whereas the fifth step (interpretation or integration of results) seven levels of evidence were used to classify the studies. Was held in Cochrane and Scientific Electronic Library Online (SciELO) libraries in the following databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE (Excerpta Medica Database), Latin American and Caribbean Literature on Health Sciences (LILACS), PubMed (U.S. National Library of Medicine National Institutes of Health), Scopus and Web of Science, referring to publications made the years 2002-2012, with descriptors / keywords used contemplated the falls terms, patients and hospitals in different search strategies. The initial selection included 33,280 articles, which after applied the inclusion and exclusion criteria resulted in a sample of 220 articles. Of the total articles, levels of evidence based on the types of studies, corresponding to the total number of articles of the present study were the II, III, IV and VI, corresponding to 10%, 0.9 %, 39.1% and 50%, respectively. Thus, descriptive studies were most present; followed the cohort, case-control and quasi- experimental, randomized controlled clinical trials, and well-designed clinical trials without randomization, respectively. It was also possible to verify the levels of evidence related to the themes of the characteristics / etiologies / risk factors and falls prevention, and post- falls conducts followed the same sequence of those with higher incidence in this study (level VI) to the lowest incidence (level III). The findings relating to the characteristics / etiologies / risk factors related to falls of hospitalized patients were distributed into 14 sub-themes, totaling 24 items, which contemplated the findings that were associated with the topic. Regarding preventive measures, it was found 19 findings, including programs for the prevention of falls; tools / risk assessment of falls; guidelines / interventions, human resources / labor dynamics, companion / sitter / volunteers; assessment scales of functionality (activities of daily living / dependency care) and motor function, call light, and nursing care. In addition to that, of 14 behaviors post- falls reported in the articles, the most present were radiographs, medication administration / analgesia, medical / expert review; simple curative / suturing, and observation. Therefore, when thinking about people\'s falls be borne in mind that a body slides or goes down due to a lack of support of itself, due to some intrinsic situation to the individual or due to external factors that contribute to person to leave their state of \"postural balance\". Thus, this study provided take a broad view on the different contexts inherent to inpatients falls in order to can develop cost-effective preventive actions that provides quality care to individuals assisted in hospitals

Objetivo: Descrever os eventos adversos pós-vacina DPT (EAPV-DPT) notificados no Estado de São Paulo entre 1984 a 2001; identificar preditores de gravidade desses eventos; avaliar o Sistema de Vigilância de Eventos Adversos Pós-Vacina DPT (SVEAPV-DPT).Métodos: Estudo descritivo e exploratório de preditores de gravidade. A definição de caso adotada é do SVEAPV, sendo este também a fonte dos dados. A avaliação do SVEAPV-DPT foi efetuada segundo metodologia proposta pelo Center for Disease Control and Prevention. Para identificação dos preditores usou-se a regressão logística não-condicional.Resultados: Foram identificados 6266 casos, dos quais 53% eram graves, 29,5% foram hospitalizados; os eventos mais freqüentes foram: febre<39,5ºC, episódio hipotônico-hiporresponsivo, reação local e convulsão. Em cerca de 75% dos casos o evento ocorreu nas primeiras seis horas após a vacinação. Mostraram-se independentemente associadas à gravidade: o intervalo de tempo inferior a uma hora entre a aplicação da vacina e o evento (OR=2,1), primeira dose aplicada (OR=5,8), antecedentes neurológicos pessoais (OR=2,2) e familiares (OR=5,3). O sistema passivo de EAPV é simples, flexível, de baixa sensibilidade, porém útil, descrevendo diferentes tipos de EAPV, identificando lotes mais reatogênicos e oferecendo subsídios para a elaboração de normas técnicas.Conclusões: Apesar das limitações, os sistemas passivos de VEAPV constituem o principal instrumento para estudar a segurança de vacinas no período pós-licença, sendo porém recomendável a incorporação de novas metodologias, entre elas a de municípios e unidades sentinelas. Além disso, é recomendável a inclusão na pauta de discussão das revisões periódicas do calendário de imunizações, a introdução da vacina DPT acelular. / Objective: Describe the DPT post vaccine adverse events (DPT- PVAE) notified in the state of São Paulo between 1984 and 2001; identify seriousness predictors of these events; evaluate the DPT Post Vaccine Adverse Events Vigilance System (DPT- PVAEVS).Methods: Descriptive and exploratory study of seriousness predictors. The case definition adopted was that of the PVAEVS, being it the data source as well. The evaluation of the DPT- PVAEVS was conducted according to the methodology proposed by the Centers for Disease Control and Prevention. To identify the predictors, non-conditional logistical regression was used.Results: 6266 cases were identified, of which 53% were serious, 29,5% were hospitalized; the most frequent events were: fever <39,5ºC, hypotonic-hyporresponsive episode, local reaction and convulsion. In around 75% of the cases, the event occurred during the first six hours after vaccination. They were show to be independently associated to the gravity: the time interval inferior to one hour between the application of the vaccine and the event (OR=2,1), first dose administered (OR=5,8), personal (OR=2,2) and family (OR=5,3) neurological history. The PVAE passive system is simple, flexible, of low sensitivity, yet useful describing different types of PVAE, identifying reatogenic lots and offering subsidies to the elaboration of technical norms.Conclusions: Despite the limitations, the PVAE passive systems constitute the main instrument to study the safety of vaccines during the post license period. Nevertheless, the incorporation of new technologies is advisable, among which are municipalities and sentinel units. Besides this, it is advisable to include the introduction of the acellular DPT vaccine as a discussion point of the periodic reviews of the immunization calendar.

Estudo quantitativo, transversal, prospectivo, realizado com o objetivo de analisar os efeitos da alocação de pessoal e da carga de trabalho de enfermagem nos resultados da assistência em duas unidades de internação (UIs) médico-cirúrgicas, com 20 e 15 leitos cada, denominadas respectivamente UI-A e UI-B, de um hospital do município de São Paulo. Utilizou-se uma metodologia capaz de abranger 87% da variação dos cuidados requeridos pelos pacientes, composta por itens que incluem a dimensão biológica e psicossocial do cuidado: o Patient Focused Solutions/Workload Measurement-Inpatient Methodology (PFS/WM-IM). Foram considerados indicadores de resultado: queda, erro de medicação, retirada não programada de sondas, cateteres ou drenos, úlcera por pressão (UP), infecção urinária (ITU) e pneumonia desenvolvidas durante a internação hospitalar. Os dados foram obtidos dos prontuários e dos registros da Comissão de Controle de Infecção Hospitalar, além da escala diária de pessoal de enfermagem. Após 47 dias consecutivos de coleta de dados, a amostra final foi composta por 387 pacientes - 218 na UI-A e 169 na UI-B. Com distribuição eqüitativa de pacientes do gênero masculino e feminino, predominaram os idosos com 61 anos ou mais (38,5% na UI-A e 36,1% na UI-B), submetidos a tratamento cirúrgico eletivo (62,8% na UI-A e 56,8% na UI-B) e média de internação de 6,0 (+-25,1) dias na UI-A e de 4,6 (+-7,2) dias na UI-B. A maioria dos pacientes da UI-A foi proveniente da residência (52,3%); na UI-B do pronto atendimento (47,3%), seguido pela residência (37,3%). Após a alta, 85,3% dos pacientes da UI-A e 87,6% da UI-B retornaram à residência. Com relação à ocorrência de eventos adversos (EAs), na UI-A, 14 pacientes (6,4%) sofreram 23 EAs (9, 3 e 2 pacientes foram vítimas de 1, 2 e 4 eventos, respectivamente, sendo 13 retiradas não programadas de sondas, cateteres ou drenos, 8 erros de medicação, 1 UP e 1 ITU). Na UI-B 12 pacientes (7,1%) sofreram 13 EAs, ou seja, 11 pacientes sofreram 1 EA e 1 foi vítima de 2 EAs, sendo 10 erros de medicação, 2 retiradas não programadas de sondas, cateteres ou drenos e 1UP. Os pacientes foram classificados predominantemente nas categorias 1, 2 e 3 (baixa e intermediária complexidade), alocados em unidades adequadas para o cuidado requerido – as unidades de internação. Havia em média 1 enfermeiro para cada unidade e cada auxiliar de enfermagem cuidou de, no máximo, 5 pacientes. A média de horas de enfermagem disponível foi maior do que o recomendado pelo PFS/WM-IM, respectivamente 7 e 5,8 h na UI-A e 6,2 e 4,9h na UI-B (p<0,001). No período analisado, apesar do excedente de pessoal de enfermagem nas UIs A e B, houve ocorrência de EAs. Os resultados deste estudo se contrapõem, portanto, às solicitações freqüentes de enfermeiros por maior quantidade de pessoal e apontam para a necessidade de novas investigações que complementem as análises realizadas, não só para as UIs médico-cirúrgicas, mas para todas as unidades do hospital / This was a quantitative, transversal, prospective study, performed with the objective of analyzing the effects of nursing personnel allocation and workload on assistance results in two medical-surgical units (MSUs), with 20 and 15 beds each, respectively named MSU-A and MSU-B at a hospital in the city of São Paulo. The methodology used was capable of comprehending 87% of the range of the care required by the patients; it was a compound of items that included a biological and psychosocial dimension of care: Patient Focused Solutions/Workload Measurement-Inpatient Methodology (PFS/WM-IM). Result indicators considered were: falling, medication errors, non-scheduled probe, catheter or drain removals, pressure ulcers (PU), urinary tract infections (UTI) and pneumonia developed during the hospital care. The data were obtained from medical reports and registers of the Commission for Hospital Infection Control, as well as the daily work schedule of the nursing personnel. After 47 consecutive days of data collection, the final sample had 387 patients - 218 in MSU-A and 169 in MSU-B. Having equal quantities of male and female patients, it had a prevalence of elderly patients with 61 years or more (38.5% in MSU-A and 36.1% in MSU-B), patients who were undergoing surgical elective treatment (62.8% in MSU-A and 56.8% in MSU-B) and those with an average number of internment days of 6.0 days (+-25.1) in MSU-A and of 4.6 days (+-7.2) in MSU-B. Most of the patients of MSU-A came from their homes (52.3%); whereas in MSU-B most of them came from emergency room facilities (47.3%), followed by those who came from home (37.3%). After the discharge, 85.3% of the patients of MSU-A and 87.6% of MSU-B returned to their homes. With respect to occurrences of adverse events (AEs), in MSU-A, 14 patients (6.4%) suffered 23 AEs (9, 3 and 2 respectively had 1, 2 and 4 events, among of them there were: 13 non-scheduled probe, catheter or drain removals, 8 medication errors, 1 PU and 1 UTI). In MSU-B, 12 patients (7.1%) suffered 13 AEs, that is, 11 patients had 1 AE and 1 had 2 AEs, in that 10 were medication errors, 2 non-scheduled removals of probes, catheters or drains and 1 PU. The patients predominantly fitted in the categories 1, 2 and 3 (low and medium complexity), allocated in units proper for the required care – the medical surgical units. There was an average of 1 nurse for each unit and each nursing assistant took care of a maximum of 5 patients. The average number of nursing hours available was higher than those recommended by PFS/WM-IM, respectively 7 and 5.8 hours in MSU-A and 6.2 and 4.9 hours in MSU-B (p<0,001). Despite the excess of nursing personnel in MSU-A and MSU-B, AEs occurred. Therefore, the results of this study oppose frequent requirements of nurses for more personnel and point to a necessity of new research to complement the herein made analysis, not only for medical-surgical units, but also for every unit in the hospital