Eventos adversos a medicamentos entre idosos no Brasil antes e após o início da pandemia da COVID-19 / Adverse drug events among older adults in Brazil before and after the onset of the COVID-19 pandemic

Introdução: Danos decorrentes de eventos adversos relacionados a medicamentos (EAM) estão entre os mais frequentes no mundo. Logo, seu monitoramento é essencial, especialmente entre os idosos que apresentam maior risco de sofrer tais danos. Adicionalmente, a pandemia da COVID-19, a sua elevada incidência entre idosos e o uso frequente de medicamentos off-label reforçaram a importância do monitoramento de EAM nessa população. Objetivo: Descrever as suspeitas de EAM entre idosos no Brasil antes e após o início da pandemia por COVID-19. Método: Foi realizada a descrição das suspeitas de EAM notificadas no sistema VigiMed da Agência Nacional de Vigilância Sanitária envolvendo idosos (idade ≥ 65 anos) no período pré-pandemia (01/2019 a 03/2020) e pós-início da pandemia (04/2020 a 06/2021). A diferença entre a proporção de EAM graves entre os períodos foi avaliada mediante teste qui-quadrado de Pearson. Resultados: Foram notificadas 57.167 suspeitas de EAM no período global avaliado; 22,2% envolviam idosos. No período pré-pandemia, 2.924 suspeitas de EAM foram notificadas (44,2% eram EAM graves), destacando-se aquelas envolvendo antineoplásicos, antimicrobianos e anticoagulantes. No período pós-início da pandemia, 9.771 suspeitas de EAM foram notificadas (57,5% graves), destacando-se a hidroxicloroquina e as vacinas contra a COVID-19. A diferença na proporção de suspeitas de EAM graves notificadas para idosos entre os períodos avaliados foi estatisticamente significativa (p < 0,001). Conclusões: Notificações de EAM e estudos que avaliem EAM entre idosos são essenciais para gerar informações que possam subsidiar a otimização da farmacoterapia e a priorização de redução de danos entre eles, sobretudo no contexto pandêmico que afeta consideravelmente essa população.

Introduction: Harm resulting from adverse drug events (ADE) is among the most frequent in the world. Therefore, its monitoring is essential, especially among older adults, who are at greater risk of suffering such type of harm. Additionally, the COVID-19 pandemic, its high incidence among older adults and frequent use of off-label medications have reinforced the importance of monitoring ADE in this population. Objective: To describe the suspected ADE among older adults in Brazil before and after the beginning of the COVID-19 pandemic. Method: A description of suspected ADEs reported in the VigiMed system of the National Health Surveillance Agency was carried out, involving older adults (age ≥ 65 years) in the pre- (01/2019 to 03/2020) and post-onset of the pandemic period (04/2020 to 06/2021). The difference between the proportion of severe ADE between the periods was evaluated using Pearson's chi-square test. Results: 57,167 suspected ADE were reported in the global period evaluated; 22.2% involved older adults. In the pre-pandemic period, 2,924 suspected ADEs were reported (44.2% were severe ADEs), especially those involving antineoplastic, antimicrobial, and anticoagulant drugs. In the post-pandemic period, 9,771 suspected ADEs were reported (57.5% severe), especially related to hydroxychloroquine and vaccines against COVID-19. The difference in the proportion of severe suspected ADE reported for the older adults between the periods evaluated was statistically significant (p < 0.001). Conclusions: ADE notifications and studies that evaluate ADE among older adults are essential to generate information that can support drug therapy optimization and prioritization of harm reduction among them, especially in the pandemic context that considerably affects this population.

Incorporation of medicines in the Unified Health System (SUS): comparison between oncology and the specialized component of pharmaceutical care. / Incorporação de medicamentos no SUS: comparação entre oncologia e componente especializado da assistência farmacêutica.

Compliance with legal deadlines for the assessment and incorporation of technologies in Brazil's Unified Health System (SUS) is essential to ensure public access to essential medicines. The scope of this paper was to analyze the compliance with legal deadlines for incorporation and availability of medicines in the SUS, comparing Oncology and the Specialized Component of Pharmaceutical Assistance (SCPA). A comparison was made of the drugs incorporated that were submitted to Conitec in the period from January 1, 2017, to April 30, 2020. A total of 85 drugs were recommended for incorporation by Conitec, of which 15 (17.64%) were for Oncology and 70 (82.36%) were for SCPA. The time between analysis and recommendation by Conitec until the publication of the decision by the Ministry of Health was, on average, 86 days longer for oncological drugs and the availability timeframe of technologies incorporated in the oncology area was, on average, 389 days longer than for SCPA. The major progress achieved with the creation of Conitec in Brazil is acknowledged, but the results of this study point to a pressing need to improve the process of making available technologies incorporated into the SUS, especially in oncology.

O cumprimento dos prazos legais para incorporação e disponibilização de tecnologias no Sistema Único de Saúde (SUS) é fundamental para o acesso da população aos medicamentos considerados essenciais. Objetivou-se analisar o cumprimento destes prazos comparando a Oncologia e o Componente Especializado de Assistência Farmacêutica (CEAF). Comparou-se os processos de incorporação de medicamentos no SUS da Oncologia e do CEAF que foram submetidos à Conitec no período de 01 de janeiro de 2017 a 30 de abril de 2020. No período, 83 processos de incorporação de medicamentos foram recomendados para incorporação pela Conitec, dos quais 13 (15,66%) eram da Oncologia e 70 (84,34%) eram do CEAF. Verifica-se que o tempo de análise e recomendação pela Conitec até a publicação da decisão pelo Ministério da Saúde foi, em média, 15 dias maior para processos que continham medicamentos oncológicos e o tempo para disponibilização das tecnologias incorporadas da área da oncologia foi, em média, 389 dias maior que do CEAF. Reconhece-se o importante avanço obtido com a criação da Conitec no Brasil, porém os resultados deste estudo apontam para a necessidade de aprimoramento do processo de disponibilização de tecnologias incorporadas no SUS, em especial da Oncologia.

Incorporação de medicamentos no SUS: comparação entre oncologia e componente especializado da assistência farmacêutica / Incorporation of medicines in the Unified Health System (SUS): comparison between oncology and the specialized component of pharmaceutical care

Resumo O cumprimento dos prazos legais para incorporação e disponibilização de tecnologias no Sistema Único de Saúde (SUS) é fundamental para o acesso da população aos medicamentos considerados essenciais. Objetivou-se analisar o cumprimento destes prazos comparando a Oncologia e o Componente Especializado de Assistência Farmacêutica (CEAF). Comparou-se os processos de incorporação de medicamentos no SUS da Oncologia e do CEAF que foram submetidos à Conitec no período de 01 de janeiro de 2017 a 30 de abril de 2020. No período, 83 processos de incorporação de medicamentos foram recomendados para incorporação pela Conitec, dos quais 13 (15,66%) eram da Oncologia e 70 (84,34%) eram do CEAF. Verifica-se que o tempo de análise e recomendação pela Conitec até a publicação da decisão pelo Ministério da Saúde foi, em média, 15 dias maior para processos que continham medicamentos oncológicos e o tempo para disponibilização das tecnologias incorporadas da área da oncologia foi, em média, 389 dias maior que do CEAF. Reconhece-se o importante avanço obtido com a criação da Conitec no Brasil, porém os resultados deste estudo apontam para a necessidade de aprimoramento do processo de disponibilização de tecnologias incorporadas no SUS, em especial da Oncologia.

Abstract Compliance with legal deadlines for the assessment and incorporation of technologies in Brazil's Unified Health System (SUS) is essential to ensure public access to essential medicines. The scope of this paper was to analyze the compliance with legal deadlines for incorporation and availability of medicines in the SUS, comparing Oncology and the Specialized Component of Pharmaceutical Assistance (SCPA). A comparison was made of the drugs incorporated that were submitted to Conitec in the period from January 1, 2017, to April 30, 2020. A total of 85 drugs were recommended for incorporation by Conitec, of which 15 (17.64%) were for Oncology and 70 (82.36%) were for SCPA. The time between analysis and recommendation by Conitec until the publication of the decision by the Ministry of Health was, on average, 86 days longer for oncological drugs and the availability timeframe of technologies incorporated in the oncology area was, on average, 389 days longer than for SCPA. The major progress achieved with the creation of Conitec in Brazil is acknowledged, but the results of this study point to a pressing need to improve the process of making available technologies incorporated into the SUS, especially in oncology.

Hospitalizations of older people in an emergency department related to potential medication-induced hyperactive delirium: a cross-sectional study.

Background Although delirium is one of the most common adverse drug reactions observed in hospitalized older people, it remains underdiagnosed. Aim To estimate the prevalence of hospitalization of older people with potential medication-induced hyperactive delirium in the emergency department (ED); to identify the risk factors and the medicines frequently associated with the occurrence of the syndrome. Method A cross-sectional, retrospective study was performed with older people (age ≥ 60) admitted in 2018 to a Brazilian ED. The hospitalizations with suspected hyperactive delirium were screened with the aid of trigger-tools: International Code of Diseases-10th Revision, intra-hospital prescriptions of antipsychotics, and trigger-words related to the syndrome. A chart-review and medication review were developed to establish the causality assessment between adverse event and medicine. Logistic regression was used to determine risk factors for occurrence. Results Among the hospitalizations included, 67.5% (193/286) were screened by at least one trigger-tool. Of these, potential medication-induced hyperactive delirium was observed in 26.0% (50/193). The prevalence estimated in the ward was 17.5% (50/286). Opioids (31.9%), benzodiazepines (18.8%) and corticosteroids (10.6%) were the commonest medicines associated with delirium. Long-lived patients (p = 0.005), potentially inappropriate medicines (PIMs) (p = 0.025), and high weighted deliriogenic load (p = 0.014) were associated with potential medication-induced hyperactive delirium. Conclusion Approximately one in six hospitalizations of older people in the ED showed potential medication-induced hyperactive delirium. Data suggest PIMs and high weighted deliriogenic load, rather than polypharmacy or anticholinergic burden, are considered the most important characteristics of pharmacotherapy associated with avoidable hyperactive delirium among long-lived patients.

Virtual consent and the use of electronic informed consent form in clinical research in Brazil.

OBJECTIVE: In view of the need to apply term free and informed consent (IC) in clinical research involving humans, in accordance with the Brazilian ethical standards (CNS Resolution No. 466/2012), it is necessary to assess whether this practice is being effective and can be improved. The aim of this study was to evaluate the use of the IC in electronic format (e-IC), regarding its feasibility and suitability, as a complement to the written/physical consent form. METHODS: Quantitative-qualitative research with a questionnaire instrument. RESULTS: Greater retention of information and fewer wrong answers were observed after the application of the e-IC. CONCLUSIONS: The use of e-IC is of great value to research participants in Brazil.

Incidence and preventability of adverse events in adult patients admitted to a Brazilian teaching hospital.

OBJECTIVE: To analyze the incidence and preventability of adverse events related to health care in adult patients admitted to a Brazilian teaching hospital. METHODS: A retrospective cohort study, in which the incidence and preventability of adverse events related to health care were based on a two-stage retrospective review of 368 medical records (nurses and pharmacist review of medical records, followed by physicians review of triggered medical records) of adult patients whose hospitalizations occurred during 2015 in a high-complexity public teaching hospital located in Brazil. Data were collected from February 2018 to February 2019. RESULTS: A total of 266 adverse events were observed in 124 patients. The incidence of adverse events related to health care was 33.7% (95% CI 0.29-0.39), and the incidence density was 4.97 adverse events per 100 patient-days. Adverse events were responsible for 701 additional days of hospitalization, and the estimated length of additional hospital stay attributable to them was, on average, 6.8 days per event. The most common types of events were related to general care (60; 22.6%), medications (50; 18.8%), nosocomial infection (35; 13.2%), any other type (11; 4.1%), and diagnoses (2; 0.8%). Regarding the severity of adverse events, it was found that 168 (63.2%) were mild, 55 (20.7%) were moderate, and 43 (16.2%) were severe. In addition, it was estimated that 155 (58.3%) events were preventable. The length of a patient's hospital stay was identified as a risk factor for the occurrence of adverse events (RR 1.20; 95% CI 1.04-1.39). CONCLUSIONS: Through knowledge of the incidence, nature, severity, preventability, and risk factors for the occurrence of adverse events, it is possible to create the opportunities to prioritize the implementation of strategies for mitigating specific events based on reliable data and concrete information.

Placebo use and outcome quality: A protocol for systematic review and meta-analysis.

BACKGROUND: The Pharmaceutical industry sponsorship, research outcome and quality has been already evaluated for clinical trials in order to analyze if this kind of sponsorship affects the results of clinical trials. In this sense, this study has the aim to investigate whether placebo use allows positive outcomes regarding efficacy and safety compared to synthetic medicines. METHODS: We designed and registered a study protocol for a systematic review for methodology data. We will only randomized clinical trials that use placebo as comparator. The main outcome will be the evaluation of placebo use regarding the tendency for positive results (efficacy and security) when comparing to synthetic medicines. PubMed, Cochrane, LILACS (BVS), Web of Science, Scopus, and Excerpta Medica dataBASE (EMBASE) databases will be searched. Gray literature will be identified through the databases Proquest (Dissertation and Theses), OpenGrey and Google Scholar. Two review authors will independently assess trial quality and will extract data in accordance with standard Cochrane methodology. If necessary, we will also contact authors for additional information. The Cochrane Collaboration's risk of bias tool will be used. If feasible, it means homogenous data, we will conduct random effects meta-analysis. Subgroup analyses will be conducted for different justifications for placebo use and for studies sponsored/not sponsored by the pharmaceutical industry. RESULTS: Our present findings will indicate the effects of placebo use as comparator regarding efficacy and safety of the oral synthetic medicines. DISCUSSION: This systematic review will identify, summarize, and analyze if there is a trend for positive efficacy and safety results for synthetic medicines in clinical trials when compared with placebo and if the justification for placebo use is considered ethically acceptable. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018110829.

Pharmacological therapies for patients with human coronavirus infections: a rapid systematic review. / Terapia medicamentosa para infecções por coronavírus em humanos: revisão sistemática rápida.

This work aimed to evaluate the effects of drug therapies for coronavirus infections. Rapid systematic review with search in the MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov and International Clinical Trials Registry Platform databases. Thirty-six studies evaluating alternative drugs against SARS, SARS-CoV-2 and MERS were included. Most of the included studies were conducted in China with an observational design for the treatment of COVID-19. The most studied treatments were with antimalarials and antivirals. In antimalarial, the meta-analysis of two studies with 180 participants did not identify the benefit of hydroxychloroquine concerning the negative viral load via real-time polymerase chain reaction, and the use of antivirals compared to standard care was similar regarding outcomes. The available scientific evidence is preliminary and of low methodological quality, which suggests caution when interpreting its results. Research that evaluates comparative efficacy in randomized, controlled clinical trials, with adequate follow-up time and with the methods properly disclosed and subject to scientific peer review is required. A periodic update of this review is recommended.

The Control and Prevention of COVID-19 Transmission in Children: A Protocol for Systematic Review and Meta-analysis.

BACKGROUND: The pandemic following the rapid spread of the new SARS-CoV-2 virus has hit all continents and caused thousands of deaths worldwide. Evidence has been published on epidemiological and clinical characteristics of population groups considered at risk; however, information for the other population groups, especially for the child population, is needed. In this context, this protocol describes a systematic review that will aim to identify the evidence on control and prevention of COVID-19 transmission among children and adolescents, as well as to describe the epidemiological profile and clinical and immunological characteristics of COVID-19 in this population. METHODS: This protocol will be developed in accordance with PRISMA-P. The searches will be conducted in PubMed, Web of Science, ScienceDirect, EMBASE, and Scopus, seeking clinical trials. Observational studies and case reports with Children and adolescents (≤19 years) infected with SARS-CoV-2 will be included whether they report information on the control of prevention and COVID-19 transmission. Two independent researchers will perform the selection of articles, removal of duplication, and screening by Rayyan QCRI application. Cochrane's RoB 2.0, ROBINS-I, and CASP tools will be used to assess the risk of bias. Meta-analysis, subgroup analyses, and/or descriptive analyses will be carried out based on the data conditions included. RESULTS: A high-quality synthesis of the available evidences on the epidemiological profile, the clinical and immunological characteristics involved in children, and adolescents diagnosed with COVID-19, as well as the participation of this population in the transmission dynamics of SARS-CoV-2 will be provided. CONCLUSION: This systematic review has an important relevance in the current context because it has a great potential to help the development of new control and prevention strategies in the pediatric population. RECORD OF SYSTEMATIC REVIEW: CRD42020179263.

Terapia medicamentosa para infecções por coronavírus em humanos: revisão sistemática rápida / Pharmacological therapies for patients with human coronavirus infections: a rapid systematic review

Resumo O objetivo deste trabalho foi avaliar efeitos de tratamentos medicamentosos para infecções por coronavírus. Revisão sistemática rápida com buscas nas bases MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov e International Clinical Trials Registry Platform. Foram incluídos 36 estudos avaliando alternativas medicamentosas contra SARS, SARS-CoV-2 e MERS. A maioria dos estudos incluídos foi conduzida na China com delineamento observacional para tratamento da COVID-19. Os tratamentos mais estudados foram antimaláricos e antivirais. Nos antimaláricos, a metanálise de dois estudos com 180 participantes não identificou benefício da hidroxicloroquina em relação à negativação da carga viral via reação em cadeia de polimerase em tempo real e o uso de antivirais comparado ao cuidado padrão foi similar em relação aos desfechos. As evidências científicas disponíveis são preliminares e de baixa qualidade metodológica, o que sugere cautela na interpretação dos dados. Pesquisas que avaliem a eficácia comparativa em ensaios clínicos randomizados, controlados, com tempo de acompanhamento adequado e com os métodos devidamente divulgados e sujeitos à revisão científica por pares são necessárias. Recomenda-se atualização periódica da presente revisão.

Abstract This work aimed to evaluate the effects of drug therapies for coronavirus infections. Rapid systematic review with search in the MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov and International Clinical Trials Registry Platform databases. Thirty-six studies evaluating alternative drugs against SARS, SARS-CoV-2 and MERS were included. Most of the included studies were conducted in China with an observational design for the treatment of COVID-19. The most studied treatments were with antimalarials and antivirals. In antimalarial, the meta-analysis of two studies with 180 participants did not identify the benefit of hydroxychloroquine concerning the negative viral load via real-time polymerase chain reaction, and the use of antivirals compared to standard care was similar regarding outcomes. The available scientific evidence is preliminary and of low methodological quality, which suggests caution when interpreting its results. Research that evaluates comparative efficacy in randomized, controlled clinical trials, with adequate follow-up time and with the methods properly disclosed and subject to scientific peer review is required. A periodic update of this review is recommended.

Implementação de um painel de indicadores on-line para segurança do paciente / Implementation of an online indicator panel for patient safety / Implementación de un panel de indicadores on-line para la seguridad del paciente

Objetivo: Apresentar o processo de implementação de um painel de indicadores de segurança do paciente (PISP) para benchmarking em uma rede de hospitais universitários federais (HUF) brasileiros administrados por uma empresa pública. Síntese dos dados: Descrição de experiência de criação de ferramenta eletrônica, responsável pela temática segurança do paciente, ocorrida entre janeiro de 2016 e dezembro de 2018. A construção do PISP seguiu as seguintes etapas: definição de 62 indicadores de saúde; apresentação, qualificação e uniformização dos dados a serem coletados; cadastro dos responsáveis dos HUF na plataforma web; e alimentação do sistema, com a inserção dos dados pelos 39 HUF. A implantação do PISP priorizou 23 indicadores utilizados por instituições acreditadoras e recomendados por documentos nacionais, distribuídos entre indicadores de processo (13%) e de resultado (87%). Os resultados foram o envolvimento dos 39 HUF, a troca de experiências, o compartilhamento de informações e a institucionalização do Programa Gestão à Vista, que oportuniza o monitoramento contínuo desses indicadores na instituição para o aprimoramento da qualidade dos serviços de saúde. A experiência trouxe imenso aprendizado, proporcionando aos envolvidos desenvolver habilidades durante o processo. Destacam-se como dificuldade o processo de implantação de uma cultura de avaliação contínua e como facilidade a disponibilidade dos atores envolvidos na adesão dessa proposta. Conclusão: O painel de indicadores de segurança do paciente apresenta-se como recurso inovador no monitoramento de processos e resultados da implantação dos Núcleos de Segurança do Paciente, trazendo uma característica importante de sistemas de gestão da qualidade: transparência na gestão e divulgação de resultados.

Objective: To present the process of implementing a patient safety indicators panel (PISP) for benchmarking in a network of Brazilian federal university hospitals (HUF) managed by a public company. Synthesis of data: Description of the experience of creating an electronic tool, responsible for thematic patient safety, which took place between January 2016 and December 2018. The construction of the PISP followed the following steps: definition of 62 health indicators; presentation, qualification, and standardization of the data to be collected; registration of HUF managers on the web platform; and feeding the system, with data input by the 39 HUF. The implementation of the PISP prioritized 23 indicators used by accrediting institutions and recommended by national documents, distributed among process (13%) and result (87%) indicators. The results were the involvement of the 39 HUFs, the exchange of experiences, the sharing of information, and the institutionalization of the Management in Sight Program, which provides opportunities for the continuous monitoring of these indicators in the institution to improve the quality of health services. The experience brought immense learning, allowing those involved to develop skills during the process. The process of implementing a culture of continuous evaluation stands out as difficulty and the availability of the actors involved in adhering to this proposal as ease. Conclusion: The panel of patient safety indicators presents itself as an innovative resource in monitoring the processes and results of the implementation of the Patient Safety Centers, bringing an important characteristic of quality management systems: transparency in the management and dissemination of results.

Objetivo: Presentar el proceso de implementación de un panel de indicadores de seguridad del enfermo (PISE) para benchmarking en una red de hospitales universitarios federales (HUF) brasileños administrados por una empresa pública. Síntesis de los datos: Descripción de la experiencia de creación de la herramienta electrónica responsable por la temática seguridad del enfermo que se dio entre enero de 2016 y diciembre de 2018. La construcción del PISE siguió las etapas a continuación: definición de 62 indicadores de salud; presentación, cualificación y uniformización de los datos a recoger; registro de los responsables de los HUF en la plataforma web; y alimentación del sistema con la inserción de los datos de los 39 HUF. La implantación del PISE ha priorizado 23 indicadores utilizados por las instituciones acreditadoras y recomendadas por documentos nacionales distribuidos entre los indicadores de proceso (13%) y de resultado (87%). Los resultados fueron el envolvimiento de los 39 HUF, el cambio de experiencias, el compartir de informaciones y la institucionalización del Programa Gestión a la Vista que ofrece la oportunidad del monitoreo continuo de los indicadores en la institución para el enriquecimiento de la calidad de los servicios de salud. La experiencia trajo mucho aprendizaje promocionando a los involucrados el desarrollo de habilidades durante el proceso. Se destaca como dificultad el proceso de implantación de una cultura de evaluación continua y como facilidad la disponibilidad de los actores involucrados en la adhesión a esa propuesta. Conclusión: El panel de indicadores de seguridad se presenta como recurso innovador para el monitoreo de procesos y resultados de la implantación de los Núcleos de Seguridad del Enfermo con una característica importante de los sistemas de gestión de la calidad: la transparencia de la gestión y la divulgación de los resultados.

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital.

OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%), fatigue (12.3%), and chest pain (9.0%). Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases.

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%), fatigue (12.3%), and chest pain (9.0%). Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases. .

The need to establish a national patient safety program in Brazil.

The aim of the study was to promote reflection on the need to create a national incident notification system based on a brazilian patient safety program. Incidents in health care harm patients and encumber the health care system. Although a quality assessment program has been recently launched in health care institutions, the Brazilian Ministry of Health does not yet have a program which systematically assesses negative outcomes of health care. This article discusses the need to establish a national patient safety program in Brazil, aiming to promote a culture of patient safety and quality health care in the Brazilian Unified Health System.

[Patient safety: a comparison between handwritten and computerized voluntary incident reporting]. / Segurança do paciente: comparação entre notificações voluntárias manuscritas e informatizadas sobre incidentes em saúde.

This study's objective was to compare two types of voluntary incident reporting methods that affect patient safety, handwritten (HR) and computerized (CR), in relation to the number of reports, type of incident reported the individual submitting the report, and quality of reports. This was a descriptive, retrospective and cross-sectional study. CR were more frequent than HR (61.2% vs. 38.6%) among the 1,089 reports analyzed and were submitted every day of the month, while HR were submitted only on weekdays. The highest number of reports referred to medication, followed by problems related to medical-hospital material and the professional who most frequently submitted reports were nurses in both cases. Overall CR presented higher quality than HR (86.1% vs. 61.7%); 36.8% of HR were illegible, a problem that was eliminated in CR. Therefore, the use of computerized incident reporting in hospitals favors qualified voluntary reports, increasing patient safety.

Segurança do paciente: comparação entre notificações voluntárias manuscritas e informatizadas sobre incidentes em saúde / Seguridad del Paciente: comparación entre la notificación espontánea manuscrita y computadorizada de incidentes en la salud / Patient Safety: a comparison between handwritten and computerized voluntary incident reporting

O objetivo do trabalho foi comparar dois tipos de notificação voluntária sobre incidentes que afetam a segurança dos pacientes, manuscrita (NM) e informatizada (NI) quanto ao número, ao tipo de incidente relatado, notificador e qualidade dos relatos. Tratou-se de um estudo descritivo, retrospectivo transversal. Das 1089 notificações analisadas, NI foram mais frequentes que NM (61,2% vs 38,6%), sendo realizadas em todos os dias dos meses, e as NM apenas em dias úteis. O maior número de notificações referiu-se aos medicamentos, seguidos de problemas relacionados aos artigos médico-hospitalares, e o profissional que mais relatou foi o enfermeiro, em ambos os casos. No geral, NI tinham mais qualidade que NM (86,1% vs 61,7%), sendo que 36,8% das NM eram ilegíveis, problema que foi eliminado com a informatização da notificação. Portanto, o uso de notificações informatizadas sobre incidentes em saúde nos hospitais favorece relatos espontâneos qualificados, ampliando a segurança dos pacientes.

Estudio con el objetivo fue comparar dos tipos de notificación voluntaria de incidentes que afectan a la seguridad del paciente, manuscrita (NM) y computarizada (NC), por las variables: número de notificaciones, el tipo de incidente reportado, el notificador y la calidad de los informes. Este era un estudio descriptivo, retrospectivo, transversal. De un total de 1089, las NC fueron más frecuentes que el NM (61,2% vs 38,6%), notificado todos los días del mes. El mayor número de notificaciones se refiere a los medicamentos, seguidos por problemas relacionados con los medicamentos y las enfermeras han notificado más en ambos casos. En general, NC tenía una calidad superior a la NM (61,7% vs 86,1%), con el 36,8% de NM eran ilegibles, problema que fue eliminado con la informatización. Por lo tanto, el uso de las notificaciones computadorizadas de incidentes en la asistencia en los hospitales favorece informes espontáneos cualificados, y, consecutivamente, una mayor seguridad de los pacientes.

This study's objective was to compare two types of voluntary incident reporting methods that affect patient safety, handwritten (HR) and computerized (CR), in relation to the number of reports, type of incident reported, the individual submitting the report, and quality of reports. This was a descriptive, retrospective and cross-sectional study. CR were more frequent than HR (61.2% vs. 38.6%) among the 1,089 reports analyzed and were submitted every day of the month, while HR were submitted only on weekdays. The highest number of reports referred to medication, followed by problems related to medical-hospital material, and the professional who most frequently submitted reports were nurses in both cases. Overall, CR presented higher quality than HR (86.1% vs. 61.7%); 36.8% of HR were illegible, a problem that was eliminated in CR. Therefore, the use of computerized incident reporting in hospitals favors qualified voluntary reports, increasing patient safety.

Incorporação de Tecnologias em Saúde no Brasil: novo modelo para o Sistema Único de Saúde / Incorporation of Techonologies in Health in Brazil: a New Model for the Brazilian Public Health System (Sistema Único de Saúde - SUS)

O avanço tecnológico das últimas décadas proporcionou melhorias na qualidade da saúde da população e redução nas taxas de mortalidade de um número considerável de doenças. Entretanto, grande oferta destas novas tecnologias torna necessário que, além dos benefícios, seus riscos e custos sejam avaliados no processo de tomada de decisão para disponibilizá-las ao sistema de saúde, promovendo o uso racional de tecnologias. Com a necessidade de institucionalizar um modelo de processo de incorporação de tecnologias em saúde que fosse amparado legalmente, foi publicada a Lei 12.401/2011 que cria a Comissão Nacional de Incorporação de Tecnologias no SUS ­ CONITEC, com o papel de assessorar o Ministério da Saúde quanto à incorporação, exclusão ou alteração de novas tecnologias no SUS. A nova legislação fixa um prazo para a tomada de decisão, bem como inclui a análise baseada em evidências, levando em consideração aspectos como eficácia, acurácia, efetividade e a segurança da tecnologia, além da avaliação econômica comparativa dos benefícios e dos custos em relação às tecnologias já existentes. Espera-se, com isso, que o processo de incorporação de tecnologias no SUS seja mais ágil, transparente e eficiente, garantindo à população brasileira o seu direito constitucional de acesso universal e integral à saúde.

Clima de segurança do paciente: percepção dos profissionais de enfermagem / The climate of patient safety: perception of nursing professionals

OBJETIVO: Avaliar a percepção do clima de segurança dos profissionais de enfermagem atuantes nas clínicas médicas e cirúrgicas de um Hospital de Ensino. MÉTODOS: Estudo transversal, descritivo e com abordagem quantitativa. Foi utilizado o Safety Attitudes Questionnaire (SAQ) - Short Form 2006, traduzido para a língua portuguesa. RESULTADOS: A percepção do clima de segurança dos profissionais variou conforme o gênero, a clínica, a categoria profissional e o tempo de atuação. A satisfação no trabalho foi demonstrada por todos os profissionais, com escores acima de 75, enquanto o domínio Percepção da Gerência apresentou valores mais baixos. CONCLUSÃO: A satisfação do profissional, o diálogo e o suporte à equipe por parte da administração são essenciais para a garantia da segurança do paciente. Conhecer a percepção dos profissionais de enfermagem sobre o clima de segurança contribui para a melhoria do cuidado em saúde e para a redução dos riscos ao paciente.

OBJECTIVE: To evaluate the perception of the safety climate of nursing professionals working in the medical and surgical clinics of a teaching hospital. METHODS: A cross-sectional, descriptive study using a quantitative approach. We used the Safety Attitudes Questionnaire (SAQ) - Short Form 2006, translated into the Portuguese language. RESULTS: The perception of the safety climate of the professionals varied according to gender, clinic, professional category and time of work. Job satisfaction was demonstrated by all professionals, with scores above 75, while the domain of Perception of Management presented much lower values. CONCLUSION: Professional satisfaction, dialogue and support for the team on the part of the administration are essential to ensuring patient safety. To know the perception of nursing professionals about the climate of safety contributes to the improvement of health care and to the reduction of risks to the patient.

OBJETIVO: Evaluar la percepción del clima de seguridad de los profesionales de enfermería que actúan en las clínicas médicas y quirúrgicas de un Hospital de Enseñanza. MÉTODOS: Estudio transversal, descriptivo y con abordaje cuantitativo. Fue utilizado el Safety Attitudes Questionnaire (SAQ) - Short Form 2006, traducido para la lengua portuguesa. RESULTADOS: La percepción del clima de seguridad de los profesionales varió conforme el género, la clínica, la categoría profesional y el tiempo de actuación. La satisfacción en el trabajo fue demostrada por todos los profesionales, con scores arriba de 75, en cuanto que el dominio Percepción de la Gerencia presentó valores más bajos. CONCLUSIÓN: La satisfacción del profesional, el diálogo y el soporte al equipo por parte de la administración son esenciales para la garantía de la seguridad del paciente. Conocer la percepción de los profesionales de enfermería sobre el clima de seguridad contribuye para la mejoría del cuidado en salud y para la reducción de los riesgos del paciente.