Bakgrund: Patientsäkerhetsarbete bedrivs inom hälso-och sjukvården för att minimera risker att skador, tillbud eller negativa händelser uppstår under tiden patienter erhåller vård. Det främsta målet inom hälso- och sjukvården är att lindra människors lidande, trots detta är det väl dokumenterat att vissa vårdsituationer leder till lidande, förvirring och otrygghet. Syfte: Denna studie syftar till att beskriva sjuksköterskors erfarenheter av patientsäkerhetsarbete. Metod: Detta examensarbete utformas som en systematisk litteraturstudie med utgångspunkt i en beskrivande syntes. Resultat: I resultatet framkom två teman: Organisationens påverkan på sjuksköterskor samt Sjuksköterskors gemensamma ansvar. Utifrån dessa framkom även fyra subteman: Att möta hinder i sin vardag, Att sakna information, Att aktivt välja ett ansvarsfullt ledarskap samt Att kontinuerligt utveckla sin kompetens. Sjuksköterskor har ett professionellt ansvar, framför allt mot patienter. Kommunikation kan inte begränsas till att dela information inom teamet. Patientsäkerhetskulturen formas när chefer är hängivna till att skapa, forma och överföra denna kultur till organisationen. Slutsatser: Att behöva tampas med ogynnsamma arbetsförhållanden, stress, bristfälligt ledarskap och sin egen utveckling på daglig basis framkommer som utmattande. Positiva erfarenheter genomlyser de negativa genom att sjuksköterskor använder de brister och hinder de erfar i sin vardag för att utveckla sig själva, sin egen kompetens och sin egenmakt.

Trata-se de um estudo de abordagem quantitativa, descritivo, prospectivo, que teve como objetivos comparar o volume de dieta enteral prescrito com o administrado aos pacientes internados em Unidades de Terapia Intensiva (UTI); comparar as necessidades calóricas diárias (NCD) dos pacientes com as necessidades calóricas prescritas (NCP) e as administradas (NCA); identificar os motivos e os fatores associados a não administração do volume da dieta enteral prescrita aos pacientes. O estudo foi realizado no período de 21 de agosto a 21 de novembro de 2005, em duas UTIs gerais de um hospital privado do Município de São Paulo. A coleta dos dados foi feita diariamente por meio de informações contidas no prontuário e na folha de controle da Unidade. Para a análise dos dados, utilizou-se a estatística descritiva para caracterizar a amostra de pacientes, a dieta enteral e os motivos da não administração do volume prescrito. A comparação das médias do volume prescrito com o administrado, assim como das médias das NCD com as NCP e as NCA foram feitas com o teste t-Student para amostras pareadas. Para as comparações, segundo faixas de volumes e calorias foi utilizado o índice Kappa. Valores de p<0,05 foram considerados estatisticamente significantes. O método de regressão logística aplicado para verificar os fatores associados à não administração da dieta enteral foi o Stepwise forward que incorporou ao modelo as variáveis que apresentaram significância estatística (p<0,05) ou tendência à significância estatística (0,05<p<0.10). A amostra foi constituída por 61 pacientes, sendo realizados 636 acompanhamentos diários da administração da dieta enteral. Do total de pacientes, observou-se que, em algum momento do acompanhamento, 72,1% não receberam o volume prescrito. O tempo decorrido entre a internação na UTI e o início da TNE foi, em média, de 2,5 dias. Das avaliações feitas (n=636), a maioria das dietas (57,6%) eram especializadas e foram administradas por meio de sondas enterais posicionadas no estômago (56,9%). Dos 604 acompanhamentos em que houve prescrição médica de dieta, em 30,2% houve pausa na administração (duração média de 6,1 horas), durante o período programado para a infusão da dieta e em 23,6% a administração foi contínua em razão do uso de bomba de insulina. Constatou-se que, em média, o volume de dieta administrado, 1118,8 ± 400,4 ml, foi menor do que o prescrito, 1257,2 ± 306,9 ml (p=0,000). A análise comparativa das NCD com as NCP e NCA mostrou evidência estatística (p=0,000) que permite afirmar que tanto as NCP como as NCA, foram, em média, menores do que as NCD dos pacientes. NCA (1164,8 ± 508,2) foram menores do que as NCD (1797,1± 292,7calorias) requeridas pelos pacientes. 59,0% dos pacientes conseguiram atingir pelo menos 80,0% das NCD, em média com 4,8 dias de TNE. A comparação dos valores classificados por faixas mostrou moderada concordância entre os volumes prescritos e administrados (Kappa=0,614) e baixa concordância entre as NCD e NCP (Kappa=0,191) e NCD e NCA (Kappa=0,100). De um total de 308 motivos que levaram a não administração do volume prescrito (1,06 motivos por acompanhamento) o cálculo errado da velocidade de infusão pela equipe de enfermagem foi predominante (20,8%), seguido pela realização de exames diagnósticos ou terapêuticos e procedimentos cirúrgicos (14,9%). Do total de motivos, 70,6% eram evitáveis. Os fatores associados a não administração do volume de dieta enteral prescrito foram a idade (diminuição de 7% do risco a cada ano acrescentado à idade), a velocidade de infusão (diminuição de 4% do risco a cada ponto de aumento da velocidade) e necessidade calórica diária (aumento de 0,4% da chance a cada unidade calórica requerida pelo paciente). Os resultados apontam para a necessidade de um maior número de estudos que investiguem os eventos adversos relacionados à administração da dieta enteral com vistas a assegurar o atendimento das reais necessidades nutricionais dos pacientes graves internados na UTI. / It talks about a study of prospective, descriptive and quantitative approach, which has as objectives to compare the volume of enteral diet which was prescribed with the one administrated to the interned patients in the Unit of Intensive Care (UIC); to compare the daily caloric necessities (DCN) of the patients with the prescribed caloric necessities (PCN) and the administrated ones (ACN); to identify the reasons and the factors associated to the absence of the administration of the volume of prescribed enteral diet to the patients. The study took place between 21st of August and 21st of November, 2005 in two general units of intensive care of a private hospital in the city of São Paulo. The data assessment was done on a daily basis through information which was in the prontuary and the papers of control on the Intensive Care. For the data analyses a descriptive statistics was used to distinguish the patients, the enteral diet and the reasons of the absence of administration of the prescribed volume. The comparison of the average of the 2 volumes (prescribed and administrated), as well as the average among the DCN with the PCN and ACN was done with the t-Student test to matched samples. To the comparisons concerning volumes and calories the rate Kappa was used. Values of p<0,05 were considered statistically meaningful. The method of logistic regression applied to check the factors associated with the absence of administration of enteral diet was the Stepwise forward which attached to the model the variables that present statistics significance (p<0,05) or likeliness to statistics significance (0,05<p<0,10). The sample was of 61 patients with 636 daily attendances of the administration of enteral diet. From the total of the patients, it was observed that in a certain moment of the attendance, 72,1% did not receive the prescribed volume. The time between the internment in the UIC and the beginning of the enteral nutritional therapy (ENT) was, on average of 2,5 days. From the evaluations which were done (n=636) the majority of the diets (57,6%) were specialized and were administrated through enteral catheter placed in the stomach (56,9%). From the 604 attendances which had diet medical prescription , in 30,2% there was a pause in the administration (length of 6,1 hours), in the programmed period for the infusion of the diet and in 23,6% the administration was the continuous due to the use of insulin bomb. It was seen that, on average, the volume of the diet which was administrated, 111,8+/- 4000,4 ml, was smaller that the prescribed, 1,257,2+/- 306 ,9 ml (p=0,000). The comparative analyses of the DCN with the PCN and CAN showed statistics evidence (p=0,000) which shows that not only the PCN but also the CAN were, on average, smaller that the DCN of the patients. The ACN (1164,8+/- 508,2) were smaller that the DCN (1797,1 +/- 292,7 calories) required by the patients. 59 ,0% of the patients could reach at least 80,0% of the DCN, on average with the 4,8 days of ENT. The comparison of the values classified by strips showed a moderate concordance between the prescribed and administrated volumes (Kappa=0,614) and low concordance between the DCN and PCN ( Kappa=0,191) and DCN and ACN (Kappa=0,100). From a number of 308 reasons of the absence of the administration of the prescribed volume (1,06 reasons by attendance) the wrong calculation of the speed from the infusion by the nursing team was predominant (20,8%) followed by diagnostic or therapeutic exams and surgical procedures (14,9%). From all reasons, 70,6% were avoidable. The factors associated to the absence of administration of the volume of prescribed enteral diet were the age (decrease of 7% of risk to each year added to the age), the speed of infusion (decrease of 4% of risk to each point of speed increase) and the daily caloric necessity (increase of 0,4% of chance to each required caloric unit by the patient). The results lead to a necessity of more numerous studies that look into adverse events related to the administration of enteral diet to guarantee the real nutritional necessities of serious patients interned in the UIC.

O uso de equipamentos e materiais na assistência à saúde contribui para a segurança do paciente e para o bom desempenho dos profissionais, porém não se pode desconsiderar o potencial de riscos trazido pela utilização destes e a possibilidade de ocorrências de eventos adversos (EA). O objetivo geral dessa investigação foi analisar o uso de equipamentos e materiais na assistência de enfermagem e sua relação com a ocorrência de EA. Trata-se de um estudo quantitativo, descritivo, com delineamento de pesquisa não-experimental, dividido em três etapas: 1ª) Revisão integrativa da literatura com busca nas bases de dados PubMed, CINAHL e LILACS; 2ª) Consulta às fichas informatizadas de notificação de EA de um hospital privado acreditado, registradas no período de 01/01/2011 a 30/06/2015, com vistas à seleção e análise dos eventos ocasionados pelo uso de equipamentos e materiais; 3ª) Elaboração, validação e aplicação de um instrumento de coleta para investigar os EA relacionados aos equipamentos e materiais e as estratégias utilizadas para propiciar o uso seguro desses dispositivos. Os principais resultados encontrados foram: 1ª) Seleção e análise de sete artigos, agrupados nas categorias: \"Métodos de registro, taxas de ocorrência e tipos de EA\" e \"EA ocorridos no transporte de pacientes críticos\" (ambos relacionados a equipamentos e materiais); 2ª) Constatado a notificação de 1.065 EA, sendo 180 (16,9% do total) relacionados ao uso de equipamentos e materiais na assistência de enfermagem: perda de sonda de alimentação (SNE, SNG, SOG e gastrostomia) (45,0%), perda de cateter venoso central (15,5%), lesão de pele (10,5%), extubação acidental (10,0%), perda de sonda vesical de demora (4,4%), erros de administração de medicamentos (bomba de infusão) (3,9%), perda de dreno (2,8%), tecnovigilância (2,8%), obstrução de cânula de traqueostomia (1,7%), perda de cateter de pressão arterial invasiva (1,7%), quedas (1,1%) e perda de cateter de analgesia (0,5%); 3ª) O instrumento foi elaborado, validado por cinco juízes e aplicado a 22 enfermeiros, apresentando as seguintes respostas: a) sobre o funcionamento inadequado ou o não funcionamento dos equipamentos, os mais citados foram bomba de infusão, cama elétrica, esfigmomanômetro, monitor multiparamêtrico, oxímetro de pulso e ventilador pulmonar mecânico; b) os EA provocados pela utilização inadequada ou incorreta de materiais foram lesão de pele, perda de sonda de alimentação, perda de cateter venoso central, perda de drenos, extubação acidental, perda de cateter de pressão arterial invasiva e perda de cateter de pressão intra-craniana; c) os EA ocorreram durante mudança de decúbito, administração de medicamentos, higiene corporal, transporte intra-hospitalar, atendimento de Urgências/Emergências e troca da fixação de cateteres e sondas; d) as estratégias preventivas prioritárias foram capacitação dos profissionais de enfermagem (na admissão e na aquisição de um novo equipamento ou material), utilização de protocolos assistenciais de enfermagem e manutenção preventiva / teste de qualidade prévio dos dispositivos. A aquisição de aparatos tecnológicos modernos se torna nula se não for acompanhada do investimento em capacitação dos profissionais de enfermagem das instituições de saúde e da preocupação em prevenir e minimizar a ocorrência de EA relacionados ao uso de equipamentos e materiais na assistência ao paciente / The use of equipment and materials in health care contributes to patient safety and to the good performance of professionals, but the potential for risks brought by the use of them and the possibility of adverse event (AE) occurrences cannot be ignored. This study aimed to analyze the use of equipment and materials in nursing care and its relationship to the AE occurrence. This is a quantitative, descriptive, non-experimental research design study, divided into three stages: 1) Integrative review with search in the databases PubMed, CINAHL and LILACS; 2) Consultation in computerized records of AE notification in an accredited private hospital, which were registered from January 1, 2011 to June 30, 2015, in order to select and to analyze events caused by the use of equipment and materials; 3) Development, validation and application of a data collection tool to investigate the AE related to equipment and materials and the strategies used to promote the safe use of these devices. The main results were: 1) Selection and analysis of seven articles, grouped into the following categories: \"Registration methods, occurrence rates and types of AE\" and \"AE occurred in the transport of critically ill patients\" (both related to equipment and materials); 2) After verifying the notification of 1,065 AE, and 180 (16.9% of the total) related to the use of equipment and materials in nursing care: feeding tube loss (SNE, SNG, SOG and gastrostomy) (45,0%), central venous catheter loss (15.5%), skin lesions (10.5%), accidental extubation (10.0%), bladder catheter loss (4.4%), medication administration errors (infusion pump) (3.9%), surgical drain loss (2.8%), technical surveillance (2.8%), tracheostomy tube obstruction (1.7%), invasive arterial pressure catheter loss (1,7%), falls (1.1%) and analgesia catheter loss (0.5%); 3) The instrument was developed, validated by five judges and applied to 22 nurses, with the following answers: a) about the improper functioning or non-functioning of equipment, the most common were infusion pump, electric bed, sphygmomanometer, multiparameter monitor , pulse oximeter and mechanical pulmonary ventilator; b) the AE caused by improper or incorrect use of materials were skin lesions, feeding tube loss, central venous catheters loss, surgical drain loss, accidental extubation, invasive arterial pressure catheter loss and intracranial pressure catheter loss; c) the EA occurred during change of decubitus, medication administration, personal hygiene, intra-hospital transport, Urgency/Emergency care and exchange of fixation of catheters and probes; d) priority preventive strategies were training of nursing professionals (on admission and in the purchase of new equipment or materials), use of nursing care protocols and preventive maintenance/quality prior testing of the devices. The acquisition of modern technological devices becomes invalid if it is not accompanied by investment in training of nursing professionals in health institutions and concerned to prevent and minimize the occurrence of adverse events related to the use of equipment and materials in patient care

Este trabalho apresenta os resultados de uma pesquisa que teve como objetivo avaliar o desempenho de métodos de mineração de textos na previsão e detecção de Eventos Adversos (EA). A primeira etapa foi a revisão sistemática da literatura que buscou identificar os métodos de mineração de textos e as áreas da saúde que esses estão sendo aplicados para prever e detectar EA. Após essa etapa foi realizada uma aplicação de métodos de mineração de textos para prever Infecções do Sítio Cirúrgico (ISC) a partir do texto livre de descrições cirúrgicas no Hospital de Clínicas de Porto Alegre (HCPA). Por fim, métodos de mineração de textos foram aplicados para detectar ISC a partir do texto das evoluções de pacientes 30 (trinta) dias após uma cirurgia. Como resultados, destaca-se a identificação dos melhores métodos de pré-processamento e mineração de textos para prever e detectar ISC no HCPA, podendo ser aplicados a outros EA. O método Stochastic Gradient Descent (SGD) apresentou o melhor desempenho, 79,7% de ROC-AUC na previsão de EA. Já para detecção de EA o melhor método foi o Logistic Regression, com desempenho 80,6% de ROC-AUC. Os métodos de mineração de textos podem ser usados para apoiar de maneira eficaz a previsão e detecção de EA, direcionando ações de vigilância para a melhoria da segurança do paciente. / This work presents the results of a research that aimed to evaluate the performance of text mining methods in the prediction and detection of Adverse Events (AE). The first step was the systematic review of the literature that sought to identify the methods of text mining and the health areas they are being applied to predict and detect AE. After this step, an application of text mining methods was performed to predict Surgical Site Infections (SSI) from the free text of medical records at Hospital de Clínicas de Porto Alegre (HCPA). Finally, text mining methods were applied to detect SSI from the text of medical records 30 (thirty) days after surgery. As results, is highlight the identification of the best methods of pre-processing and text mining to predict and detect SSI in the HCPA, and can be applied to other AE. The Stochastic Gradient Descent (SGD) presented the best performance, 79.7% of ROC-AUC in the prediction of AE. Already for the detection of AE the best method was the Logistic Regression, with performance 80.6% of ROC-AUC. Text mining methods can be used to effectively support the prediction and detection of AE by directing surveillance actions to improve patient safety.

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

Made available in DSpace on 2016-04-27T13:10:24Z (GMT). No. of bitstreams: 1 Thatira Postali Jacinto Pezato.pdf: 1000855 bytes, checksum: 4600871594a9cccf53fdf8b3add0bcc1 (MD5) Previous issue date: 2014-08-08 / Today it exists a wide range and a larger consumption of medicines and little of the risks of those medicines is known for the patient, because the collection of safe information is still a difficult factor. The risk of damages becomes smaller when these are prescribed, released and administered by professionals of the health informed and qualified to understand and to identify potential situations of risk and like this, prevention measures can be taken for the safety of the use of the medicines. This work had as purpose to characterize and to identify the notifications of adverse reactions, adverse events and/or deviations of quality of medicines accomplished in the chemotherapy units and internments of a private hospital, in the period of May to November of 2013. In a first phase, the adverse reactions, quality deviations and adverse events were classified to medicines that happened the months of May, June and July of 2013 following by a training with small applied groups for the responsible researcher. This training was proceeded by the application of a questionnaire with closed questions that sought to measure the degree of the professionals' knowledge, the recognition of the adverse reactions inside to medicines and the importance of the farmacovigilância of the hospital. In the second phase, they were classified the notifications of adverse reactions, adverse events and quality deviations that happened the months of September, October and November of 2013. An increase of 387,5% of the notifications was observed after the training. It was also verified that little understanding exists on farmacovigilância for the professionals of the health, what favored the subnotificação. Was ended that the training on farmacovigilância propitiated the professionals of the health was effective, it increased the number of notifications in the studied units. It is understood that the education enlarges the communicative processes, it establishes the communication and these professionals' collaboration / Hoje existe uma ampla gama e um maior consumo de medicamentos e sabe-se pouco dos riscos desses medicamentos para o paciente, pois a coleta de informações seguras ainda é um fator dificultoso. O risco de danos torna-se menor quando estes são prescritos, dispensados e administrados por profissionais da saúde informados e capacitados para compreender e identificar situações potenciais de risco e assim, medidas de prevenção possam ser tomadas para a segurança do uso dos medicamentos. Este trabalho teve como finalidade caracterizar e identificar as notificações de reações adversas, eventos adversos e/ou desvios de qualidade de medicamentos realizada nas unidades de quimioterapia e internações de um hospital privado, no período de maio a novembro de 2013. Em uma primeira fase, foram catalogadas as reações adversas, desvios de qualidade e eventos adversos a medicamentos que aconteceram nos meses de maio, junho e julho de 2013 seguido de um treinamento com pequenos grupos aplicados pelo pesquisador responsável. Este treinamento foi procedido pela aplicação de um questionário com perguntas fechadas que visaram medir o grau de conhecimento dos profissionais, o reconhecimento das reações adversas a medicamentos e a importância da farmacovigilância dentro do hospital. Na segunda fase, foram catalogadas as notificações de reações adversas, eventos adversos e desvios de qualidade que aconteceram nos meses de setembro, outubro e novembro de 2013. Observou-se um aumento de 387,5% das notificações após o treinamento. Também se verificou que existe pouco entendimento sobre farmacovigilância pelos profissionais da saúde, o que favoreceu a subnotificação. Conclui-se que o treinamento sobre farmacovigilância propiciado aos profissionais da saúde foi efetivo, aumentou o número de notificações nas unidades estudadas. Compreende-se que a educação permanente amplia os processos comunicativos, estabelece a comunicação e a colaboração destes profissionais

As HIV is now primarily a chronic condition, treatment is given life-long with changes as necessitated by alterations in tolerability and efficacy. Thus, personalized medicine may be useful in the prevention of unnecessary drug exposure and avoidable side effects. Three of the four currently available HIV integrase strand transfer inhibitors (INSTIs), raltegravir, elvitegravir, and dolutegravir, are widely utilized antiretrovirals in the USA and exhibit variations in outcomes among subjects. To interrogate differences among subjects receiving these drugs, we investigated the association of several single nucleotide polymorphisms (SNPs) with drug exposure, clinical outcomes, and subject-reported adverse events. HIV+ adults (≥18 years old) receiving an INSTI regimen were recruited (n=88). Subject genotypes were evaluated using an iPLEX PGx Panel. Genetic variations within our population, underwent multiple regression with covariates [age, sex, BMI, regimen duration, and baseline variables (as required) along with specific regimen in the comprehensive group] to detect significant (p=0.028) between abnormal dream occurrence and specific INSTI regimen with the raltegravir grouping presenting a higher frequency. This exploratory study also discovered several SNP-outcome associations when using INSTIs. Although these SNPs were found to have a role in predicting segments of adverse effect profiles, the clinical significance of these findings remains to be determined. Larger studies will be needed to confirm these exploratory findings with functional studies to understand pathogeneses. In conclusion, the associations found in this study strengthen the need for further assessment, within the HIV+ population, of factors contributing to unfavorable subject outcomes.

The purpose of this study was to investigate the time of admission to a Neonatal Intensive Care Unit (NICU) and its association with in-hospital mortality among a cohort of neonates at a regional perinatal center. Two different time points were considered: admissions on the weekend versus the weekday and admissions during the nighttime shift versus the day shift. The secondary purpose of the study was to investigate if registered nurse staffing affected this association between NICU admission day or admission time and in-hospital death. Three separate databases were used which contained information on NICU admissions, hospital deliveries and nurse staffing. These databases were linked resulting in data for each individual mother-infant pair for each separate admission to the NICU. Readmissions to the NICU, NICU admissions which could not be linked with the delivery data, admissions from the Newborn Nursery and transfers from other hospitals were excluded from the study. The final study population consisted of 1,846 admissions from October 1, 2001 through December 31, 2006. Weekend admissions were lower than weekday admissions (29.6% versus 70.4%) and nighttime admissions were lower than day admissions (43.2% versus 56.8%). Infants admitted at nighttime were more likely to be low birth weight, have lower Apgar scores and less likely to be delivered by cesarean section. Weekend admissions did not differ significantly from weekday admissions, except weekend admissions were more likely to be Black (33.6% versus 28.6%, p=.30). After adjusting for infant's acuity and other covariates using multivariate logistic regression, the odds of dying on the weekend was not significantly different than weekday admissions (AOR=1.06, 95% CI=.653-1.721) and were not significantly different for nighttime admissions (AOR=1.14, 95% CI=.722-1.79). Nurse staffing was not a significant covariate. Covariates which were significant risk factors for death prior to discharge were non-Black race of the infant, Apgar score of less than 7 at five minutes, presence of a fetal anomaly, and use of ventilation during the stay. Infant's birth weight was a significant protective factor.

This study examined the potential significant differences in the distribution of adverse drug reactions (ADRs) by reporter (consumer versus physician) and patient outcome at case and event level. This study also contains exploratory questions to evaluate reporting of ADRs by consumers versus physician by system organ class (SOC) and reporter demographics within the United States Food & Drug Administration Adverse Event Reporting System (FAERS). The theoretical foundation applied in this quantitative study was the social amplification of risk framework. Data from the second quarter of 2016 were obtained from FAERS, and a total of 87,807 ADR reports corresponding to 143,399 ADRs were analyzed by utilizing the chi-square test, the odds ratio, and logistic regression. Cross-sectional design was employed to compare reporting of ADRs at the case and event level (case-based and event-based analyses, respectively) between reporters (consumer versus physician), specifically, for patient outcome, as well as SOC and reporter demographics. For both the case-based and event-based analyses, findings revealed that consumers reported more serious ADRs in comparison to physicians. Furthermore, findings confirmed a difference in ADR reporting between consumers and physicians depending on SOC groups. Additionally, consumers reported more nonserious ADRs in comparison to physicians. The results from this study may have implications for positive social change by augmenting pharmacovigilance systems at a national and international level to identify risks and risk factors spontaneously reported after drugs have been on the market.

The research presented in this dissertation harnesses two secondary data sources, administrative databases of patient-level healthcare data and adverse event (AE) data reported in randomized clinical trials (RCTs), to assess the relationship between intravenous immune globulin (IVIg) and the risk of clinically serious thromboembolic adverse events (TEEs). Since 2013, IVIg products have carried a boxed warning concerning TEE risk, a determination supported by numerous case reports, a large claims-based risk assessment, and laboratory evaluations of the thrombogenecity of IVIg products. Questions remain concerning the magnitude of the risk overall and across subgroups of IVIg users. Taken together, our results are compatible with the conclusion that the absolute risk of TEE following IVIg use is likely to be low overall. While these results are reassuring, a clinically meaningful elevation in risk cannot be ruled out in certain patient sub-groups, such as older adults and others with a high baseline risk of TEE. A limitation of our research is that differences in TEE risk across products could not be evaluated with sufficient statistical power.