Characterization of patient safety incidents reported by patients or families to the brazilian health regulatory system – 2014 – 2019

Patient safety incidents, especially adverse events (AEs), are a global public health issue. The objective of the study was to characterize patient safety incidents reported by patients or families to the Brazilian Health Regulatory System (SNVS). This is a descriptive, retrospective study with a quantitative approach, using a database from the Brazilian Health Regulatory Agency (ANVISA), NOTIVISA - Citizen module, 2014 to 2019. A total of 1355 safety incident were reported, a majority from the Southeast region (45.3%), occurred more frequently among women (58.0%) aged between 26 and 35 (16.7%) and 56 and 65 years (16.5%). Healthcare-associated infections (HAIs) (36.3%) were the most frequently notified event, followed by medication/intravenous fluid (IV) incident (36.2%). Injury was mostly classified as mild (32.0%) and moderate (23.7%). From a total of 33 deaths, the majority (51.5%) were due to HAI. There was a significant association between the proportion of deaths and age group (p-value = 0.032). Most notifications were related to HAIs, followed by drugs or IV fluids and most reported incidents resulting in death were due to HAIs, with a significant difference observed in the proportion of deaths in relation to age group. The study demonstrates the need for greater encouragement and participation of patients and family members in reporting incidents, valuing their experiences for continuous learning from errors in health services.