The Protagonism of the Brazilian Health Regulatory System in the Evolution of Patient Safety in the Country: History, Dilemmas, and Current Challenges.

OBJECTIVE: This article aims to identify and analyze the legal and regulatory frameworks with an interface with patient safety, considering the historical path of the patient safety policy in Brazil. METHODS: This is a historical review based on the relevant literature to the topic such as papers, legislation, and official documents with an interface with public health policies from 1988 to 2019. We also performed a documentary search to include data from the Brazilian Health Regulatory Agency (ANVISA) such as normative and nonnormative regulatory instruments. After organizing the data, the process of content analysis was performed. RESULTS: We debated initially the historical aspects of sanitary surveillance of health services in addition to main actions taken by the Brazilian Health Regulatory System, which includes sanitary regulation and patient safety challenges. We identified a diversity of regulations published by ANVISA in the past decade related to patient safety, in addiction to sanitary actions. These initiatives culminated in the establishment of the National Patient Safety Program in 2013, followed by other health improvements, such as surveillance, incidents monitoring, and safe practices self-assessment. CONCLUSIONS: The regulation and sanitary actions directed to patient safety in Brazil have increased after the creation of ANVISA. In the face of this activities, the social role played by the Brazilian Health Regulatory System toward the advancement in the field of risk minimization in health services can be highlighted as a protagonist in the process of promoting patient safety.

Molecular epidemiology and risk factors for nasal carriage of staphylococcus aureus and methicillin-resistant S. aureus in infants attending day care centers in Brazil.

Investigations regarding Staphylococcus aureus carriage among Brazilian children are scarce. We evaluated the determinants of S. aureus and methicillin-resistant S. aureus (MRSA) nasal carriage in infants attending day care centers (DCCs) and the molecular features of the MRSA strains. A total of 1,192 children aged 2 months to 5 years attending 62 DCCs were screened for S. aureus and MRSA nasal carriage. MRSA isolates were characterized by pulsed-field gel electrophoresis, multilocus sequence typing, spa typing, staphylococcal cassette chromosome (SCC) mec typing and the presence of the Panton-Valentine leukocidin gene. Logistic regression was performed to determine risk factors associated with S. aureus and MRSA colonization. S. aureus and MRSA carriage were detected in 371 (31.1%) and 14 (1.2%) children, respectively. Variables found to be independently associated with an increased risk for S. aureus carriage included being older than 24 months (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.3 to 2.6) and previous DCC attendance (OR, 1.5; 95% CI, 1.0 to 2.2). Having a mother with a high level of education was a protective factor for nasal colonization (OR, 0.4; 95% CI, 0.2 to 0.8). Moreover, we observed that more children carrying MRSA had younger siblings than children not colonized by MRSA. Among the 14 MRSA strains, three SCCmec types (IIIA, IV, and V) were detected, together with a multidrug-resistant dominant MRSA lineage sharing 82.7% genetic similarity with the Brazilian clone (ST239-MRSA-IIIA; ST indicates the sequence type determined by multilocus sequence typing). Although SCCmec type V was recovered from one healthy child who had been exposed to known risk factors for hospital-associated MRSA, its genetic background was compatible with community-related MRSA. Our data suggest that DCC attendees could be contributing to MRSA cross-transmission between health care and community settings.

Serotype and genotype distributions of pneumococcal carriage isolates recovered from Brazilian children attending day-care centres.

Pneumococcal nasopharyngeal carriage isolates recovered from Brazilian children attending day-care centres in 2005 were assessed for serotype, genotype and penicillin susceptibility phenotype. As 124 of the 253 isolates (49 %) were characterized previously with respect to serotype and penicillin susceptibility, the primary objectives were to examine clonal associations and penicillin susceptibility within major serotypes and to assess the suitability of conventional multiplex PCR for deducing carriage serotypes within this population. Using a combination of PCR-based serotyping and the Quellung reaction, serotypes were identified for 81 % (205/253) of the isolates, with serogroups or types 14, 6, 23F, 19F and 18 being predominant. Included within the 205 isolates successfully serotyped by PCR were 28 isolates that had become non-viable. Forty-eight isolates were non-typable using both the PCR method and the Quellung reaction. Penicillin non-susceptibility was observed within 16 of the 18 multilocus sequence types detected. Thus, this study provides further evidence from a diverse collection of pneumococcal clones that PCR-based serotype deduction is useful for providing supportive evidence for pneumococcal conjugate vaccine implementation.

Taxa de mortalidade por asma de acordo com os atestados de óbito nos moradores em Cascavel/PR no período de jan/05 a dez/09 / Asthma mortality rates according to the death certifications among inhabitants of Cascavel, PR during 2005-2009

A prevalência estimada de asma no Brasil (21%) coloca-o em 8º lugar no ranking mundial. As taxas de mortalidade por asma costumam variar entre os países e são moduladas por fatores externos à doença, tais como o nível de desenvolvimento dos recursos de saúde disponíveis e a qualidade do sistema de registros de óbitos. Este trabalho teve como objetivo quantificar e analisar a taxa de mortalidade por asma nos moradores da cidade de Cascavel/PR. Os dados foram selecionados dos atestados de óbito dos moradores no município de Cascavel, PR, ocorridos de janeiro de 2005 a dezembro de 2009, sem limitação de faixa etária, que contivessem em qualquer das partes a citação de asma (J45), na 10ª revisão da Classificação Internacional de Doenças (CID 10). Os dados foram obtidos no Sistema de Informações sobre Mortalidade (SIM) da Secretaria Municipal de Saúde. A asma foi identificada como causa associada em 17 óbitos, correspondendo ao coeficiente médio de mortalidade de 1,11/100.000 habitantes, diferente do observado em outros países. Observou-se que a mortalidade associada à asma foi maior nas faixas etárias mais altas. O gênero não pareceu ser uma variável importante. A maioria das mortes ocorreu em hospitais e não houve maior ocorrência de óbitos em determinada época do ano. Não se pôde avaliar com acurácia o diagnóstico de asma dos óbitos, nem se a asma contribuiu ou não para o óbito, pois não se teve acesso à identificação e dados de internação dessas pessoas.

Brazil is the 8th country in the world in asthma prevalence (approximately 21%). Mortality rates for asthma vary among countries and are modulated by external factors, such as the level of development of health resources available and the quality of the system of death records. This study aimed to analyze and quantify the asthma mortality rate in people living in thecity of Cascavel, PR, from 2005 to 2009. Data were selected from death certificates of residents of Cascavel, PR, registered from January 2005 to December 2009, which contained in any field asthma (ICD 10, code J45), without limitation of age. Data were collected from Mortality Information System (SIM) in the Health secretary of Cascavel. Asthma was identified as an associated cause in 17 deaths, corresponding to an average mortality rate of 1.11 per 100,000 inhabitants, different from the observed in other countries. It can be observed that the mortality associated with asthma was higher in higher age groups. The genderdoes not seem to be an important variable. Most deaths occurred in hospitals and there was not a higher incidence of deaths related to certain period of the year. We were unable to assess accurately the diagnosis of asthma deaths, nor if asthma contributedto death or not, because there were no identification available and admission data of such people.