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Epidemiologia e Serviços de Saúde

versão impressa ISSN 1679-4974versão On-line ISSN 2237-9622

Epidemiol. Serv. Saúde vol.30 no.4 Brasília dez. 2021  Epub 26-Nov-2021 


Patient safety incidents and adverse events reported by Brazilian citizens: a descriptive study, 2014-2018

Vanessa Cristina Felippe Lopes Villar (orcid: 0000-0002- 4469-2796)1  , Mônica Martins (orcid: 0000-0002-9962-0618)2  , Elaine Teixeira Rabello (orcid: 0000-0002-8324-1453)3 

1Fundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, RJ, Brazil

2Fundação Oswaldo Cruz, Escola Nacional de Saúde Pública Sergio Arouca, Rio de Janeiro, RJ, Brazil

3Royal Tropical Institute, Amsterdam, Netherlands



To describe incidents related to healthcare services reported by Brazilian citizens on the Health Surveillance Notification System.


This was a descriptive study, using the database from the Health Surveillance Notification System (Notivisa) of the Brazilian Health Regulatory Agency (Anvisa), 'citizen' module, between 2014 and 2018.


935 incidents were reported, most of them occurred among females (60.9%), the elderly (20.1%) and those of white race/skin color (51.0%). The majority of the reported incidents were related to the use of medications (50.8%), falls (7.5%) and healthcare-associated infections (HAIs) (7.2%), which occurred during provision of healthcare, treatment or surgery (37.3%), in daytime (58.3%) and in hospital setting (37.4%).


It could be seen a low adherence to the notification system among the citizens. There was a higher frequency of incidents related to medications, falls and HAIs. This shows that citizens have the capability to recognize and report these incidents as patient safety issues.

Keywords: Patient Safety; Information Systems; Patient Participation; Quality of Health Care; Descriptive Epidemiology.


The importance of patient participation and engagement in all levels of care to ensure his or her safety and quality of healthcare provision, has been increasingly recognized, especially in the international scenario.1 Patient-centered care and perception play an important role, often a distinct or complementary perspective to that of the health professional.2 Notifications of incidents related to healthcare, made by patients, family members and caregivers, provide useful information necessary for improving patient’s safety and quality of the care. These notifications may include incidents that are not recognized or reported by health professionals on notification systems.3 The analysis of these incidents also showed that their occurrence may be due to the accumulation of failures over a long time period related to the care delivered, from the hospital to the home environment and the community where the patient lives.2 In a study conducted in England in 2018, patients identified incidents related to communication (21.7%), care provided by health professionals (13.2%), problems with the care environment (12.2%) and medications (9.9%).4 According to another study, conducted with 80 patients in a surgical clinic in Brazil, 17.5% of them identified some types of incidents during their hospitalization, the most frequently occurring during the medication process (78.5%).5

The World Health Organization created the Patients for Patient Safety program in order to ensure that the patient voice is heard and promote patient’s perception at all levels of care, aiming at bringing together patients, families and caregivers to improve health care safety.6 To join this initiative, several organizations have developed strategies aimed at strengthening patient participation and engagement, and implemented different actions, involving not only patients but also their families.7.8 Among these strategies for the promotion of patient participation, incident reporting systems were made available, built and adopted in several countries.9-12

In the Brazilian context, the National Patient Safety Program13 implemented a voluntary incident reporting system due to patient safety concerns. The Brazilian Health Regulatory Agency (Anvisa) developed the Health Surveillance Notification System (Notivisa) in order to receive notifications of incidents, adverse events and technical complaints. Recognizing the importance of health professionals and patients in providing care, Notivisa offers two notification modules for different target audiences: (i) professionals working at the Patient Safety Centers and (ii) citizens - patients, family members, caregivers, friends and ‘other’.14 The so-called 'citizen' module records voluntary notifications of incidents and adverse events reported by patients, family members, caregivers, friends and ‘other’. In recent years, studies based on information from Notivisa have been published; however, there were no analyses performed using the 'citizen' module.15.16

Given the challenge of ensuring the safety during provision of healthcare, such initiatives to promote the active participation of patients need to be checked; among them the magnitude and characteristics of incidents related to health services based on patients’ and family members’ perspective, recorded in notification systems. The objective of this study was to describe the incidents related to health services reported by Brazilian citizens on Notivisa.


Study design

This was a cross-sectional descriptive study, based on the notifications recorded on Notivisa - 'citizen' module.12


All notifications made on Notivisa - 'citizen' module, between January 2014, the year of its implementation, and December 2018 were analyzed.


Considering the system variables and the predefined and immutable categories, the variables analyzed were:

  1. Year of notification;

  2. Federative Unit (notifying municipality);

  3. Individual responsible for the notification (friend; caregiver; family; patient; others);

  4. Age group (in years: ≤1; 2-4; 5-11; 12-17; 18-25; 26-35; 36-45; 46-55; 56-65; ≥66);

  5. Gender (male; female);

  6. Race/skin color (white; brown; black; Asian; indigenous; had no information);

  7. Type of incident (medication use; patient falls; healthcare-associated infections (HAIs); administrative activities; health products; pressure ulcer; use of blood and derivatives; patient identification; surgery; patient protection and care failures; clinical or pathology laboratories; patient accidents; radiological service; blood donation or blood components; transplantation, grafting or fertilization; dietary management; other);

  8. Levels of care (during the provision of care, treatment or surgery; patient was not hospitalized; during diagnosis; during the admission or access to health service; in follow-up after discharge; at the time of discharge; during transfer to another institution or service; provision of care or surgery; during or after blood donation);

  9. Incident location (hospital setting; outside the health service; outpatient clinic; pharmacy or drugstore; primary health center [PHC]; emergency care center; nuclear medicine; radiological service; hemodialysis service; clinical analysis laboratory and pathological anatomy; hemotherapy service; mental and psychiatric health service or institution);

  10. Period of the day (in daytime; during the night or at dawn; had no information); and

  11. Degree of damage (none; mild; moderate; severe; death).

Data sources and measurement

The data analyzed, obtained from Notivisa-'citizen' module, were requested through the Access to Information Law and forwarded to the principal researcher on December 12, 2019, via e-mail. Data were made available according to the structure of the system. In addition to the pre-categorized variables, the system has a field for open-ended questions called 'other', used frequently to report incidents foreseen in closed categories, especially those related to medications, surgeries, health products, HAIs and falls. The variable 'incident type' has one more category named 'other'; this was reclassified by reading the recorded information, based on the International Classification for Patient Safety.17 First, we sought to reclassify the category 'other' in the previously defined fields. For the notifications whose reclassification of the type of incident did not fit the defined categories, we decided to group and name them according to activities or characteristics. To illustrate this grouping, examples of the most frequent and serious notifications recorded as 'other', showed in the results, were selected.

Data analysis

A descriptive analysis of the frequency distribution of variables related to incidents in health services available in the 'citizen' module was performed using the SPSS program version 24.0.

Ethical aspects

This research was approved by the Research Ethics Committee of Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz. Opinion No. 3,492,606, issued on August 7, 2019 - Certificate of Submission for Ethical Appreciation 17593419.7.0000.5240.


In Brazil, citizens reported 935 incidents related to health services between 2014 and 2018. Of the 197 notifications whose type of incident was categorized as 'other', 92 were reclassified (Table 1). The most frequently notified incidents and adverse events were related to medication use (50.8%), patient falls (7.5%) and healthcare-associated infections (7.2%) (Table 1). Of the 105 reclassified notifications, 70 described types of incidents that had not been foreseen on the Notivisa system - 'citizen' module. This description made it possible to allocate the incidents in new groups, such as those related to clinical process or procedure, behavior and structure (Table 2). However, 35 notifications were not reclassified or grouped due to inaccuracy or incompleteness of the answers.

The highest frequency of notifications was found in 2018 (44.9%), followed by 2016 (23.3%), 2015 (11.8%), 2017 (11.0%) and 2014 (9.0%). The majority of notifications came from the Southeast (37.5%), followed by the Northeast (24.2%), South (16.5%), Midwest (15.8%) and North (6.0%). With regard to the Federative Unit, the highest frequencies were observed in the states of São Paulo (15.5%), Minas Gerais (15.4%) and Maranhão (10.9%), and the lowest frequency of notifications was found in Paraíba and Roraima.

Table 1 - Types of incidents reported on the Brazilian Health Surveillance Notification System (Notivisa), 'citizen' module (n=935), Brazil, 2014-2018 

Types of incidents n %
Medications uses 475 50.8
Patient falls 70 7.5
Healthcare-associated infections 67 7.2
Administrative activities 56 6.0
Health product 40 4.3
Pressure ulcer 36 3.9
Use of blood and derivatives 24 2.6
Patient identification 18 1.9
Surgery 17 1.8
Patient protection and care failures 7 0.8
Clinical or pathology laboratories 6 0.6
Patient accidents 5 0.5
Radiological service 4 0.4
Blood donation or blood components 2 0.2
Transplantation, grafting or fertilization 2 0.2
Dietary management 1 0.1
Other 105 11.2
Total 935 100.0

Table 2 - Incidents reported as 'other' on the Brazilian Health Surveillance Notification System (Notivisa) and reclassification adopted (n=70), Brazil, 2014-2018 

Types of incidents that were reported and reclassified n Examples of reported incident
Clinical process/clinical procedure 29 Poorly fixed central venous access, leading to procedure failure. Phlebitis due to venous puncture
Behavior 9 Aggressive patient companion Violence toward staff
Human resource and organizational management 8 Lack of pediatric care. Employees not qualified for the job or workplace deviation
Structure 6 Improperly disposed of medical waste. Female infirmary without bathroom for patient’s selfcare, due to the need for a bathroom renovation, by order of the manager. Lack of supply (bed sheet, soap, alcohol; employees).
Neurological disorders 5 Patient presenting with agitation and confusion, trying to leave the healthcare sector. Convulsion
Vaccines 5 Vaccine administration error. Vaccine side effects, fever over 40º C.
Allergy 4 Allergy due to ultasound gel
Circulatory System diseases 2 Cardiogenic shock
Gastrointestinal disorders 1 Bloody diarrhea
Protocol adherence failure 1 No hand hygiene
Total 70  

Table 3 - Individual responsible for the notification and characteristics of patients who were victims of incidents (n=935), Brazil, 2014-2018 

Variable N %
Individual responsible for the notification
Other 462 49.4
Affected person 239 25.6
Family member 146 15.6
Friend 48 5.1
Caregiver 40 4.3
Female 569 60.9
Male 366 39.1
Age group (years)
≤1 58 6.2
2-4 17 1.8
5-11 14 1.5
12-17 20 2.1
18-25 116 12.4
26-35 167 17.9
36-45 115 12.3
46-55 94 10.1
56-65 146 15.6
≥66 188 20.1
Race/skin color
White 477 51.0
Brown 245 26.2
Black 46 4.9
Asian 22 2.4
Indigenous 4 0.4
Had no information 141 15.1
Total 935 100,0

Table 4 - Characteristics of reported incidents (n=935), Brazil, 2014-2018 

Variables n %
Care steps or moment
During the provision of care, treatment or surgery 349 37.3
The patient was not hospitalized 346 37.0
During diagnosis 107 11.5
During the admission or access to health service 88 9.4
During follow-up after discharge 22 2.4
At the time of discharge 14 1.5
During transfer to another institution or service 5 0.5
During or after blood donation 4 0.4
Incident location
Hospital setting 350 37.4
Outside the health service 279 29.8
Outpatient clinic 85 9.1
Pharmacy or drugstore 61 6.5
Primary Health Center 49 5.3
Emergency care center 39 4.2
Nuclear medicine 35 3.7
Radiological service 12 1.3
Hemodialysis service 11 1.2
Clinical analysis laboratory and pathological anatomy 10 1.1
Mental and psychiatric health service or institution 4 0.4
Period of the day
In daytime 545 58.3
During the night or at dawn 166 17.7
Had no information 224 24.0
Incident severity
Mild 308 32.9
Moderate 247 26.4
Severe 225 24.1
None 133 14.2
Death 22 2.4
Total 935 100.0

Individuals responsible for the notification identified themselves as 'other' (49.4%), followed by the 'affected person' (25.6%). Most incidents occurred among female patients (60.9%), ≥66 years (20.1%) and of white race/skin color (51.0%); 15.1% of individuals who reported the incidents did not mention the patient's race/skin color (Table 3). With the exception of these cases with no variable information, patients of white race/skin color represented almost twice as many (60.1%) as those of brown race/skin color (30.9%), and black race/skin color that together accounted for 36.6%.

Most incidents and adverse events occurred during the provision of care, treatment or surgery (37.3%), in daytime (58.3%). Hospital setting was the ‘location of the incident’ with the majority of notifications (37.4%); 32.9% of the incidents were considered mild and 2.4% resulted in deaths (Table 4).


Most of the reported incidents were related to the use of medications, followed by patient falls and healthcare-associated infections. These incidents affected most women, the elderly and citizens of white race/skin color, and occurred more frequently during the provision of care, treatment or surgery, in the hospital and in daytime. Regarding the degree of damage, for one-third of the notifications the damage was considered mild, severe damage was the least frequent, and the proportion of deaths was less than 2.5%. The general adherence to the notification system was considered low, five years after its implementation.

The high proportion of incidents categorized as 'other' and the inaccuracy or lack of information in the open fields made the analysis difficult and therefore limited this study. After the reclassification of the incidents originally reported in the category 'other', it could be seen that most of these notifications could have been recorded in specific fields predefined in the system.

There was a low general adherence to the notification system, even five years after its implementation. During the study period (2014 to 2018), 57,281,573 hospitalizations were carried out only in the Brazilian National Health System.18 Given the incidence of adverse events, which ranges from 7.6% to 10.0%, approximately 4 million adverse events that resulted in damage could have occurred.19.20 Taking into consideration this number of hospitalizations, 935 notifications of incidents over a five-year period seems to be below expectations. This evidence is related to patients’ and family members’ perception and knowledge of health, they may be unaware of the opportunity to report to notification systems that are not well known locally and also to the fact that individuals do not have an obligation to record these incidents. Among the factors that may affect the involvement of patients and family members in notifications are issues related to the characteristics of the notification system, such as ease of notification, the use of comprehensible terms and well-elaborated questions,9 and the knowledge of patients who should perceive some kind of benefit of reporting the incidents.10 Studies that used patient-centered notification systems as a source of information analyzed a number of notifications lower than that performed here, but with circumscribed time cuts.9-11 Rethinking the system design in partnership with users, in addition to Notivisa dissemination campaigns, may be strategies capable of increasing their participation in the notification of incidents during the provision health care. Similarly, the development of new methodological approaches aiming at capturing patient report, would facilitate the patient and his or her family engagement in the notification of incidents.2

In addition to the reduced number of notifications, they were geographically circumscribed. The Southeast region concentrated most of them, comparatively, especially the states of São Paulo and Minas Gerais. This finding is important because the Southeast is the most populous region. It is more economically developed and has a larger number of health facilities, compared to other regions in the country, and consequently has a higher volume of consultations and hospitalizations.21 On the other hand, it presents the lowest number of incident notifications. The North region presents a geographical, demographic, economic and service scenario diametrically opposed to that of the Southeast. This difference should be taken into consideration when analyzing the results that were found, given that these may reflect the perspective of the users from the Southeast, although the scope of this study was national.

The most frequently reported incidents on Notivisa-'citizen' module were related to medication, falls and healthcare-associated infections with low-severity clinical condition, findings similar to those of two other studies conducted in the United States9.10 and Finland,11 published between 2017 and 2018, which used notification systems aimed at patients and family members based on medication-related problems,9.10 falls11 and infections,10 and did not reported damage.9.11

Citizens reported perceptible incidents related to healthcare, which poses a serious challenge to patient’s safety and quality of the care around the world. Medication-related problems were the most frequently reported by patients and family members, inside and outside health organizations.1.22

Falls were found to be the second most frequent type of incident. They can lead to prolonged hospital stay, treatment costs, in addition to generating severe sequelae in the patients.23 Similarly, healthcare-associated infections were the third most frequently notified event,24 they also represent a major challenge for patient safety in low- and middle-income countries,25 capable of causing harm to all individuals involved, excessive spending for the health system and families, and even deaths.25-27

Most of the reported incidents occurred among the elderly, finding similar to a medical record-based observational study, conducted in Brazil in 2019,21 partially explained by the higher number of comorbidities, longer hospital stay, and use of multiple medications.28-30 Regarding the degree of damage, mostly mild, the result was similar to that of other studies that used data from notification systems aimed at patients, family members and caregivers.9.11 However, citizens were also able to report serious incidents that resulted in death. In general, patient reports seem to be more detailed and explicit than those of health professionals, constituting a valuable source of information for the analysis and improvement of health services.30

There was a low number of notifications during the study period. It could be seen a higher frequency of incidents related to the use of medications, followed by patient falls and healthcare-associated infections. These findings show that citizens have the capability to recognize and report such incidents as patient safety issues. In order to better understand the dynamic use of this type of platform by the citizen and, consequently, improve patient and family adherence, further studies on Notivisa should be conducted based on the perspective of patient-centered care.


MM has a productivity fellow from the National Council for Scientific and Technological Development (CNPq), Brazil.


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* Article derived from the Doctoral thesis entitled 'The patient's perspective on safety and quality of healthcare in the Brazilian context: notification information systems', submitted by Vanessa Cristina Felippe Lopes Villar to the PhD in Public Health program of Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, on April 20, 2021. Mônica Martins receives a Research Productivity Scholarship, granted by the National Council for Scientific and Technological Development/Ministry of Science, Technology, Innovations and Communications: Process No. 306100/2019-3.

Associate Editor: Taís Freire Galvão -

Received: March 01, 2021; Accepted: June 01, 2021

Correspondence: Vanessa Cristina Felippe Lopes Villar - Instituto Nacional de Infectologia Evandro Chagas, Avenida Brasil, No. 4365, Manguinhos, Rio de Janeiro, RJ, Brasil. CEP: 21040-360 E-mail:

Authors’ contributions

Villar VCFL collaborated with the study conception, data analysis and interpretation, drafting and critical reviewing of the manuscript content. Martins M and Rabello ET collaborated with data analysis and interpretation and critical reviewing of the manuscript content. All authors have approved the final version of the manuscript and declared themselves to be responsible for all aspects of the work, including ensuring its accuracy and integrity.

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