Avaliação do desempenho do Sistema Nacional de Notificações para a Vigilância Sanitária: uma ferramenta do sistema de farmacovigilância no Brasil

Mota, Daniel Marques; Vigo, Álvaro; Kuchenbecker, Ricardo de Souza

doi:10.1590/1413-81232020255.19522018

Cited by 4 publications

(1 citation statement)

References 19 publications

(32 reference statements)

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“…Nos últimos anos, foram publicados estudos pautados em informações oriundas do Notivisa; contudo, não foram encontradas análises baseadas no módulo 'cidadão'. 15,16 Haja vista o desafio de garantir a segurança do cuidado em saúde, tais iniciativas de fomento à participação ativa de pacientes necessitam ser examinadas; entre elas, a magnitude e as características dos incidentes nos serviços, sob a perspectiva de pacientes e familiares, registradas nos sistemas de notificação. O objetivo deste estudo foi descrever os incidentes em serviços de saúde notificados pelos cidadãos brasileiros no Notivisa.…”

Section: Introductionunclassified

Incidentes e eventos adversos de segurança do paciente notificados pelos cidadãos no Brasil: estudo descritivo, 2014-2018

Villar

Martins

Rabello

2021

Epidemiol. Serv. Saúde

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Resumo Objetivo: Descrever os incidentes em serviços de saúde notificados por cidadãos brasileiros no Sistema de Notificação de Vigilância Sanitária. Métodos: Estudo descritivo, com base em registros no Sistema de Notificações de Vigilância Sanitária (Notivisa) da Agência Nacional de Vigilância Sanitária (Anvisa), módulo ‘cidadão’, entre 2014 e 2018. Resultados: Foram notificados 935 incidentes que, preponderantemente, ocorreram com pessoas do sexo feminino (60,9%), idosas (20,1%) e de raça/cor da pele branca (51,0%). Os incidentes mais notificados estiveram relacionados ao uso de medicamentos (50,8%), quedas (7,5%) e infecções relacionadas à assistência à saúde (7,2%), ocorridos durante a prestação do cuidado, tratamento ou cirurgia (37,3%), no período diurno (58,3%) e em hospitais (37,4%). Conclusão: Observou-se baixa adesão dos cidadãos ao sistema de notificação. Houve maior frequência de notificações de incidentes relacionados a medicamentos, quedas e infecções relacionadas à assistência. Isto evidencia o potencial dos cidadãos em reconhecer e reportar tais incidentes como problemas de segurança do paciente.

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Section: Introductionunclassified

Incidentes e eventos adversos de segurança do paciente notificados pelos cidadãos no Brasil: estudo descritivo, 2014-2018

Villar

Martins

Rabello

2021

Epidemiol. Serv. Saúde

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Predictors of the outcome of immune tolerance induction in patients with haemophilia A and inhibitors: The Brazilian Immune Tolerance (BrazIT) Study protocol

et al. 2021

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The development of inhibitors is the main complication of haemophilia A (HA) treatment. Immune tolerance induction (ITI) is the treatment of choice for inhibitor eradication. We describe the methodology of the Brazilian Immune Tolerance Induction (BrazIT) Study, aimed to identify clinical, genetic, and immune biomarkers associated with response to ITI and inhibitor recurrence. This cohort study includes people with HA (PwHA) and inhibitors (a) who require bypassing agents to treat and/or prevent bleeding, and (b) who are at any stage of ITI treatment. Patients are included in each haemophilia treatment centre (HTC). Factor VIII (FVIII) and inhibitor assessments are performed at local laboratories of each HTC. The ITI regimen followed the national protocol of the Brazilian Ministry of Health. All PwHA starts with low-dose ITI (50 IU/kg three times weekly); high-dose regimen (100 IU/kg daily) is used if there is lack of response to the low-dose ITI. Outcomes are classified as total or partial success, and failure. Standardized case report forms with clinical, laboratory, and treatment data are collected from medical files and interviews. Blood samples are collected for genetic and immune biomarkers at the time of inclusion in the study and at the end of ITI. The study is ongoing and, currently, 202/250 (80.8%) PwHA from 15 HTCs have been included. BrazIT Study is the largest cohort of PwHA and inhibitor under treatment with the same ITI regimen reported to date. This study is likely to contribute with novel predictors of ITI response.

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Recommendations for the pharmacological treatment of treatment-resistant depression: A systematic review protocol

et al. 2022

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Introduction Depression is a serious and widespread mental health disorder. Although effective treatment does exist, a significant proportion of patients with depression fail to respond to antidepressant treatment trials, a condition named treatment-resistant depression. Efficient approach should be given this condition in order to revert the burden caused by depression. Clinical practice guidelines (CPGs) are evidence-based health promotion instruments to improve diagnosis and treatment. CPGs recommendations for treatment-resistant depression must be trustworthy. The objective of the proposed study is to systematically identify, appraise the quality of CPGs for the treatment of depression and elaborate a synthesis of recommendations for treatment-resistant depression of CPGs considered to be of high quality and with high quality recommendations. Methods and analysis We will search the databases of organizations, such as PubMed, Embase, Cochrane Library, PsycInfo, and the Virtual Health Library, and organizations that develop CPGs. Three independent researchers will assess the quality of the CPGs and their recommendations using the AGREE II and AGREE-REX instruments, respectively. Given the identification of divergences and convergences as well as weak and strong points among high quality CPGs, our work may help developers, clinicians and eventually patients. Ethics and dissemination No ethical approval is required for a systematic review, as no patient data will be used. The research results will be disseminated in conferences and submitted to a peer reviewed journal.

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Avaliação do desempenho do Sistema Nacional de Notificações para a Vigilância Sanitária: uma ferramenta do sistema de farmacovigilância no Brasil

Cited by 4 publications

References 19 publications

Incidentes e eventos adversos de segurança do paciente notificados pelos cidadãos no Brasil: estudo descritivo, 2014-2018

Incidentes e eventos adversos de segurança do paciente notificados pelos cidadãos no Brasil: estudo descritivo, 2014-2018

Predictors of the outcome of immune tolerance induction in patients with haemophilia A and inhibitors: The Brazilian Immune Tolerance (BrazIT) Study protocol

Recommendations for the pharmacological treatment of treatment-resistant depression: A systematic review protocol

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