Brasil Characteristics of adverse events in primary health care in Brazil

This study aimed to evaluate the occurrence of incidents in primary health care in Brazil. Fifteen health professionals working in Family Health Strategy units agreed to anonymously and confidentially record incidents over the course of five months, using the questionnaire Primary Care International Study of Medical Errors (PCISME) questionnaire adapted to the Brazilian context. The overall rate of incidents was 1.11%. The rate of incidents that did not reach patients was 0.11%. The rate of incidents reaching patients but without causing harm was 0.09%. The rate of incidents reaching patients and causing adverse events was 0.9%. Eight types of most frequent errors and administrative failures were identified. Communication failures were the most common contributing factor to incidents in primary health care (53%). The findings show that incidents occur in primary health care (as elsewhere in the health system), but research in this area is still incipient. Patient Safety; Health Evaluation; Primary Health Care Resumo Neste estudo procurou-se avaliar a ocorrência de incidentes no cuidado à saúde ao paciente na atenção primária brasileira. Quinze profissionais de saúde que trabalham em unidades da Estratégia Saúde da Família aceitaram registrar de forma anônima e confidencial, incidentes ocorridos com os pacientes durante cinco meses, através do questionário Primary Care International Study of Medical Errors (PCISME) adaptado para o contexto brasileiro. A taxa de incidência envolvendo todos os incidentes foi de 1,11%. A taxa de incidentes que não atingiram os pacientes foi de 0,11%. A taxa de incidência de incidentes que atingiram os pacientes, mas não causaram dano foi de 0,09%.A taxa de incidência de incidentes que atingiram os pacientes e causaram evento adverso foi de 0,9%. Foram identificados oito tipos de erros e os erros administrativos foram os mais frequentes. A comunicação foi citada como sendo o fator contribuinte mais comum para ocorrência de incidente na atenção primária à saúde (53%). Os achados desse estudo demonstram que os incidentes também ocorrem na atenção primária à saúde, entretanto deve-se considerar que as pesquisas neste campo ainda são incipientes. Segurança do Paciente; Avaliação em Saúde; Atenção Primária à Saúde http://dx.doi.org/10.1590/0102-311X00194214 Marchon SG et al. 2314 Cad. Saúde Pública, Rio de Janeiro, 31(11):2313-2330, nov, 2015 Introdução Muitos profissionais e instituições de saúde que julgavam prestar cuidado em saúde com qualidade conheceram, mais recentemente, os riscos de incidentes a que os pacientes estão expostos. As pesquisas realizadas em vários países vêm revelando uma alta frequência de danos relacionados ao cuidado, alertando formuladores de políticas, gestores, profissionais de saúde e os pacientes 1. Um número significativo de estratégias voltadas para melhorar a qualidade do cuidado à saúde e consequentemente atenuar os riscos dos cuidados de saúde vem sendo proposto 2. O atributo da qualidade do cuidado à saúde – segurança do paciente – tem sido reconhecido como um dos componentes mais importantes para a melhoria da qualidade em saúde 2. O relatório Errar é Humano 3 do Instituto de Medicina dos Estados Unidos, de 1999, baseado em pesquisas de revisão retrospectiva em prontuários de hospitais de Nova York, Colorado e Utah, demonstrou a magnitude do problema e estimulou esforços de melhoria no campo da segurança do paciente. Os estudos que se seguiram priorizaram o olhar no cuidado hospitalar, deixando uma lacuna no conhecimento sobre a natureza, a frequência dos incidentes e a redução de dano aos pacientes na atenção primária à saúde 4. Há um esforço internacional para que sejam realizadas mais pesquisas sobre a segurança do paciente na atenção primária à saúde. Uma revisão sistemática 4 demonstrou que mesmo que os estudos ainda sejam incipientes, alguns métodos têm sido mais utilizados para medir os danos e compreender suas causas, e entre eles a análise dos incidentes em sistemas de notificações. Os tipos de incidentes mais encontrados na atenção primária à saúde, nesses estudos são associados à medicação e ao diagnóstico e os fatores contribuintes, mais relevantes, de incidentes são as falhas de comunicação entre os membros da equipe de saúde. Nos últimos anos, no Brasil, com a implantação da Estratégia Saúde da Família (ESF), houve uma ampliação do acesso aos serviços, aumentando o número de pacientes atendidos na atenção primária à saúde 5. A ESF responde por uma parcela expressiva dos cuidados ofertados pelo Sistema Único de Saúde (SUS) 5. Este modelo procura adotar práticas de uma atenção mais integradora, multiprofissional e humanizada, onde a comunicação entre os cuidadores é fator essencial. Em busca da melhoria contínua da qualidade no Brasil, o Ministério da Saúde desenvolveu modelos de avaliação da qualidade da assistência prestada pela ESF. Em 2005, foi criado o instrumento Avaliação para Melhoria da Qualidade da Estratégia Saúde da Família (AMQ) 6 e em 2011, o Programa Nacional de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ) 7. Através do PMAQ 7 foi realizada uma avaliação nacional sobre as condições de atendimento, nas unidades de ESF. Nessa avaliação ficou demonstrado que a qualidade do serviço ofertado foi classificada como regular em cerca de 44% das unidades. As avaliações apontaram que 62% dos profissionais de saúde não utilizavam os protocolos recomendados para a avaliação clínica inicial e apenas 38% dos profissionais de saúde que trabalhavam nas unidades informaram utilizar protocolos clínicos em situações de urgência. Embora a pesquisa em segurança do paciente na atenção primária à saúde ainda seja incipiente, existem vários métodos disponíveis na literatura internacional para avaliar os incidentes relacionados ao cuidado em saúde na atenção primária à saúde. Numa recente revisão sistemática 8 da literatura não foram encontrados estudos sobre o tema no contexto brasileiro, demonstrando uma lacuna no conhecimento sobre a realidade brasileira. Algumas questões são motivos para uma reflexão: (i) os incidentes de segurança ou eventos adversos ocorrem em decorrência dos cuidados de saúde no âmbito da atenção primária à saúde no Brasil, como em outros países? (ii) os tipos de incidentes de segurança e os fatores contribuintes mais frequentes na atenção primária à saúde na realidade brasileira se assemelham aos que acontecem em outros contextos? Esse estudo buscou respostas sobre a ocorrência de incidentes no paciente, os tipos, a gravidade dos incidentes na atenção primária à saúde, e seus fatores contribuintes no contexto brasileiro.

This study aimed to evaluate the occurrence of incidents in primary health care in Brazil.Fifteen health professionals working in Family Health Strategy units agreed to anonymously and confidentially record incidents over the course of five months, using the questionnaire Primary Care International Study of Medical Errors (PCISME) questionnaire adapted to the Brazilian context.The overall rate of incidents was 1.11%.The rate of incidents that did not reach patients was 0.11%.The rate of incidents reaching patients but without causing harm was 0.09%.The rate of incidents reaching patients and causing adverse events was 0.9%.Eight types of most frequent errors and administrative failures were identified.Communication failures were the most common contributing factor to incidents in primary health care (53%).The findings show that incidents occur in primary health care (as elsewhere in the health system), but research in this area is still incipient.

Introduction
Many health care professionals and institutions that believed they were providing quality care have recently discovered the risks of incidents for patients.Studies in various countries have revealed alarmingly high rates of adverse events, thus calling the attention of policymakers, administrators, health professionals, and patients 1 .A significant number of strategies have been proposed to improve quality and thus attenuate health care risks 2 .Patient safety has been acknowledged as one of the most important attributes in improving quality of care 2 .
The report To Err is Human 3 published by the U.S. Institute of Medicine in 1999, based on a retrospective review of hospital patient charts in New York, Colorado, and Utah, revealed the magnitude of the problem and sparked efforts to improve patient safety.Subsequent studies also focused on hospital care, leaving a knowledge gap concerning the nature and frequency of incidents and harm reduction for patients in primary health care 4 .
An international effort is underway to conduct more studies on patient safety in primary health care.A systematic review 4 showed that although studies are still incipient, several methods have been used more extensively to measure harm and understand its causes.Such methods include analysis of incidents in reporting systems.The most frequently found incidents in primary health care in these studies have been associated with medication and diagnosis, and the most relevant contributing factors for incidents have been communication failure between members of the health care team.
In recent years in Brazil, with the implementation of the Family Health Strategy (FHS), access to services has expanded, thus increasing the number of patients treated in PHC 5 .The FHS accounts for a major share of the care provided by the Brazilian Unified National Health System (SUS) 5 .The model seeks to adopt patient care practices that are more comprehensive, interdisciplinary, and humanized, in which communication among health professionals is essential.
In the search for continuous improvement of health care quality in Brazil, the Ministry of Health has developed models for evaluating the quality of care provided by the FHS.The year 2005 witnessed the tool Evaluation of Quality Improvement in the Family Health Strategy (AMQ) 6 , followed in 2011 by the National Program for Improvement of Access and Quality in Primary Care (PMAQ) 7 .The PMAQ 7 spearheaded a national evaluation of health care conditions in FHS units: quality of care was classified as fair in some 44% of services.The evaluations showed that 62% of health professionals failed to follow the recommended protocols for initial clinical workup, and that only 38% of health professionals in the units reported using clinical protocols in urgent care.
Although research on patient safety in primary health care is still incipient, there are several methods available in the international literature to evaluate incidents related to patient care in primary health care.A recent systematic literature review 8 detected no studies on the theme in Brazil, thus revealing a gap in knowledge on the Brazilian reality.
Two important questions arise: (i) do safety incidents or adverse events occur in the primary health care setting in Brazil, as in other countries?(ii) are the types of safety incidents and the most frequent contributing factors in primary health care in Brazil similar to those that occur elsewhere in the world?
The current study thus sought answers concerning the occurrence of incidents in patients, the types and severity of incidents in primary health care, and contributing factors in the Brazilian context.

Study design
An observational, descriptive, prospective study was performed in 13 FHS units in urban areas in municipalities belonging to the coastal lowlands region of the State of Rio de Janeiro, Brazil, after obtaining authorization from the municipal health administrators to invite health professionals in these units to answer a questionnaire on incidents related to patient care.

Context and participants
Twenty professionals working in the municipal health departments in the coastal lowlands region of Rio de Janeiro were selected as a convenience sample.These professionals, ten physicians and ten nurses, recorded the care provided in the Information System on Primary care (SIAB), with a weekly workload of at least 20 hours in these units.The participants recorded their gender, age, professional training, time since graduation, specialty, and time working in the FHS.
Participants were asked to anonymously and confidentially record at least ten incidents detected during their work shift over the course of five months, from October 1st, 2013, to February 28th, 2014.Participants could choose whether to answer electronically or on paper.To guarantee the professionals' anonymity, the questionnaires were identified with a letter for each profession, "P" for physicians and "N" for nurses, and were numbered from 1 to 125 as they were completed and returned.
During the initial contact, participating health professionals received an explanation on the terms used in the questionnaire and a list with descriptions of examples of possible incidents and a tutorial for completing the questionnaire.
Of the 20 professionals invited to participate in the study, three physicians refused to participate and two nurses failed to return the questionnaire in time, even after a second contact.Of the 17 professionals who agreed to participate, 15 (88%), or seven physicians and eight nurses, returned the properly completed questionnaires.Among the participating professionals, 12 (80%) were females and three (20%) were males.Age varied from a 24-year-old nurse to a 72-year-old physician.

Data collection instrument
Among the methods described in the literature 8 to evaluate patient safety in primary health care, the current study opted to apply a questionnaire for health professionals based on the Australian study Primary Care International Study of Medical Errors (PCISME) 9 .This questionnaire aims to evaluate whether some incident occurred during care, and if so, to characterize it and determine its severity and contributing factors.
The questionnaire was chosen because it was pioneering and available online at no cost and had already been replicated in several countries, including a Portuguese-language translation for a study in Portugal 10 .
The PCISME questionnaire was translated and adapted to the Brazilian context by an expert panel using the modified Delphi method 11 .Our study followed the stages used in the Australian study, adopting the available guidelines.The main adjustment to the Brazilian context was the inclusion of nurses for answering the questionnaire rather than only physicians as in Australia, due to the organizational characteristics of primary health care in Brazil.
The questionnaire consists of 16 open and closed questions for physicians and nurses to record patient incidents that had occurred in the FHS units, with guaranteed anonymity, where each questionnaire was used to record a single incident.

Variables and data analysis
The answers to the questionnaires were organized to allow identifying the reasons for incidents; those that did not reach patients; those that reached patients but did not cause harm; and those that reached patients and caused harm.To calculate incident rates, the numerator was the sum of incidents reported by participants and the denominator was the sum of patient consultations performed by participants during the five-month period (information recorded in the SIAB (Departamento de Informática do SUS.Sistema de Informação da Atenção Básica.http://www2.datasus.gov.br/SIAB/index.php,accessed on 30/Oct/2014).The result of this fraction was multiplied by one hundred.
The study adopted the definitions used in studies on patient safety in the International Classification for Patient Safety (ICPS) of the World Health Organization (WHO) 12 .The ICPS defines an incident as an event or circumstance that could have resulted or did result in unnecessary harm to the patient, from intentional or intentional acts.The incident may or may not reach the patient.When it does, it may or may not cause harm.When it does not cause harm, it is called a harmless incident, and when it causes harm it is called an adverse event.Patient safety is defined as the reduction of risk of unnecessary harm associated with health care to an acceptable minimum 12 .
Table 1 was created to describe: the types of incidents, contributing factors, their consequences for patients, and the severity of harm.Contributing factors were classified according to the definitions found in studies on safety in primary health care 8 and grouped as: failures in communication with patients; failures in communication between professionals; administrative failures; failures in care; and communication failures in the health care network.We calculated the proportion of contributing factors that were classified and the severity of harm among the incidents recorded in the questionnaires.
A scale was used to classify the severity of harm: minimal harm (recovery within a month), moderate harm (recovery from a month to a year), permanent harm, death.There was also the option: "I have no way to classify the harm" 9 .
Often the health professionals (physicians in particular) assessed the existence of error or harm according to its consequences for the patient.Therefore, a patient safety expert redefined the types of incidents attributed by the participants according to the ICPS definition 12 .
Errors that contributed to incidents were classified as in studies that used the PCISME 9,10
Of the 131 questionnaires that were returned to the researcher, six (4.6%) were excluded because the items "age", "patient's sex", and "result of the incident" had not been completed, and contact with the professional to complete the information was not possible because of anonymity.The final analysis included 125 valid questionnaires, each of which represented an incident.
Table 1 shows the 125 patients' general characteristics according to type of incident.
The majority of patients with recorded incidents were adults (n = 64, 51%) and females (n = 68, 54%).The majority of patients presented chronic diseases (n = 84; 67%) and had a complex health problem 12 (n = 50, 59%), described as a condition involving difficult clinical management 13 , ranging from the presence of comorbidities to alcohol and/or drug addiction, including neurological and psychiatric disorders.Although the questionnaire did not ask to describe the patient's complex health problem, the participants referred to mental health problems in eight patients.
Nearly half of the patients (n = 59, 47%) were exposed to some form of social vulnerability 14 .
Table 2 lists the types of incidents, consequences for the patient, contributing factors, and severity of harm.As for severity of harm, among the patients that suffered adverse events, 32 (26%) experienced permanent harm, 27 (21%) presented moderate harm, and 18 (15%) suffered minimal harm.All the deaths (8) were classified as adverse events, of which 50% (4) occurred due to communication errors in the health care network, 25% (2) due to communication errors with the patient, 12.5% (1) due to communication errors in the health care team, and 12.5% (1) due to treatment errors.In 32% (40) of the incidents it was not possible to classify the severity, occurring in 42 % (17) in treatment errors, 20% (8) of communication errors in the health care network, 15% (6) in communication errors with patients, 13% (5) in administrative errors, and 10% (4) in communication errors in the health care team.
The data obtained from the questionnaires allowed classifying the errors according to the typologies used in the Australian and Portuguese studies (Table 3).Payment errors with service providers did not apply to the Brazilian study's context.This was the approach used to compare the Brazilian study's results with those of other countries that used the PCISME questionnaire (Table 3).Administrative errors (26%) were the most frequent type in the Brazilian study, followed by communication errors (22%).
Physicians were the professionals most frequently involved in patient care errors, as in the Portuguese 10 and Australian 9 studies, namely 30% (38), followed by nurses with 13% (17), pharmacists with 12% (15), and community health workers with 5% (6).In 17% (22) of the reports, the patients themselves were identified as directly responsible for the error.
The largest proportion of errors occurred in the physician's office (25%), corroborating results from other countries.In second place came the hospital (15%), which was also seen in the Australian study (Table 4).
Eighty participants (64%) reported that they were aware of a previous occurrence of the same type of error.Meanwhile, 25 (20%) of the interviewees stated that it was rare for the same type of error to be recorded in other patients, and 20 (16%) said that the same type of error that occurred in the recorded incident is frequent in other patients.

Discussion
The overall incident rate was 1.11%, corresponding to the same error rate.In the Australian study 9 with the same methodological design, the error rate was 0.24%.The other studies that used the PCISME questionnaire did not calculate the specific rates of various types of incidents, probably because the taxonomy proposed by the WHO is quite recent 9,10,15 .
Although primary health care mainly treats less complex cases, 82% of the incidents led to or caused harm to patients, including many severe cases (25%) and deaths (7%), unlike studies elsewhere in the world 16,17 , which have mostly reported harm with minimal severity.In the Brazilian study, the most frequent place where the error occurred was the physician's office (25%), corroborating findings from other countries, followed by the hospital (15%).It is important to consider the impact that an incident in primary health care can have on patients when they are treated at other levels of care; an indirect quality indicator for primary care called hospitalizations due to conditions sensitive to primary care 18 accounts for some 20% of hospital admissions in the SUS.
The highest number of incidents was detected in older patients -over 40 years of age (n = 57; 83%), with chronic diseases (n = 17; 68%), similar to the results of studies in the United States 19 and Canada 20 , where the proportions in older patients were 81% and 92%, and in chronic diseases, with 60% and 63%, respectively.Thomas & Brennan 21 highlights that patients over 45 years of age were significantly more prone to suffer an adevrse events, due to the increase in prevalence of chronic diseases, with associated comorbidities, as a consequence of the epidemiological and demographic transition.In a study 22 in Brazilian hospitals, the 60-and-over age bracket also suffered the most adverse events.
Social vulnerability is a permanent concern in Brazil, and in this study nearly half of the patients that suffered incidents were vulnerable.Vulnerable patients generally show low treatment adherence and little autonomy to participate in the prevention of incidents 14 .In 17% (22) of the reports, patients themselves were identified as directly responsible for the error, due either to lack of adherence to the proposed treatment or lack of understanding of their health condition's severity.
The data obtained from the questionnaires allowed identifying types of errors classified in the international typologies.Using the typology, the results proved very similar in the Brazilian, Portuguese, and Australian studies, with a high prevalence of administrative errors.
An overly generic classification of errors and contributing factors can hide important information.Analysis of the contributing factors in the Brazilian and Portuguese studies showed relevant situations.The article on the Australian study did not disclose the causes of errors.
In the Brazilian study, in 38 incidents the principal contributing factor was structural, such as lack of medicines, referral beds, or support for follow-up of psychiatric patients.These factors were not found in the study from Portugal.Another specific situation in the Brazilian study was the lack of the health professional's commitment to the patient, reported in nine cases.
Communication was the most frequently cited contributing factor to incidents in primary health care (53%).Communication failure between health professionals contributed to 10% of incidents, and the professionals reported such difficulties as difficult staff communication, differences of opinion and professional views, and differences in academic training, patient safety culture, behavior, schooling, professional hierarchy, and accountability to the patient.This difficulty can be exemplified by the following quote from questionnaire 55, completed by a nurse: "Difficult staff communication leads to rework in the health care unit.People rarely admit an error in front of the administrator, for fear of reprisals.People tend to pass the buck, leading to friction in interpersonal relations.Conflict becomes virtually inevitable".
In order to improve communication among health professionals, it is necessary to promote open communication, in which professionals feel free to talk about errors that could affect patients, while making them feel comfortable to question their hierarchical superiors on patient safety issues, thereby strengthening teamwork with shared capacity for changes and motivation to act on safety's side 23 .
Communication errors between professionals and patients were described in 24% of the records.Low treatment adherence was associated with the professionals' difficulties in establishing personal ties and qualified listening with patients, besides lack of sharing information.
One physician recorded his concern with communication with patients in questionnaire 61: "Those of us that work in family health always talk a lot with the family members and take into account what the patient says.But some colleagues don't even ask the patient's name, don't even know what the patient's complaint is, and then they go and ask the patient why they didn't bring their test results to the appointment or take their medication.I consider the physician/patient relationship one of the most important patient safety factors.This dialogue establishes a relationship of trust".
In another situation, even with his concern in establishing a good physician-patient relationship, the physician that completed questionnaire 20 reported difficulties with a patient: "The patient hardly participates in his own treatment, even when I talk with him.He doesn't get involved in his health problems, fails to take his medication, and keeps drinking and smoking".
Such communication failures had already been evidenced by the PMAQ 7 : some 41% of interviewed patients reported difficulties in clarifying doubts with health professionals, and had to schedule a new appointment as a result.
In the process of improving communication between the health professional and patient, the patient-centered approach should be prioritized, respecting the patient as an active element in the care process, allowing him to help manage his own care, including a possible adverse event 24 .The health professional should provide the patient with information adapted to the individual and the situation, considering level of schooling, cultural and linguistic specificities, and cognitive development.Effective communication benefits the health professional-patient relationship and is a direct factor for treatment adherence 25 .Information for patients should be clear and written whenever possible, encouraging and training them to contribute to their own safety and explaining their prescription 26 .Some 19% of the records described communication failures between health services.The Brazilian Ministry of Health 27 describes the FHS as a regulator of the health system, seeking comprehensive access in the health services network.Effective communication in the health care network requires linkage between the various professionals comprising the health care team and between different technologically hierarchical levels of care.Some feasible strategies are known, such as the implementation of referral and counter-referral systems, electronic systems for appointments and tests, mechanisms for patients to move in the network according to the lineof-care logic, and the humanization program 27 .However, the network's problems are evidenced by the following quote from the physician that completed questionnaire 56: "The patient waits for months for an appointment with the specialist, since there is only one breast specialist in the system to meet the entire demand.The disease progresses and we in the Family Health Strategy can't do anything".
The contributing factors described as administrative failures 8 (13%) that compromise quality of services provided to patients and described in articles on safety in PHC include: lack of medical and surgical supplies and medicines, professionals pressured to be more productive in less time, patient chart errors, errors in receiving patients, inadequate infrastructure of the health unit, inadequate waste disposal at the health unit, overwork, and lack of computer and internet access.
A nurse describes a situation of administrative failure in questionnaire 26: "Administrators should be concerned about offering an acceptable minimum for working, since we've gone weeks without drinking water here at the health [....].We can't close the clinic's doors, because we have to care for patients even if the working conditions are unhealthy".
The national evaluation report by PMAQ 7 describes numerous management errors in the primary health care units.Only 30% of the units evaluated by the PMAQ had one or more consultation rooms with a computer and internet connection, and only 18% of the health professionals in the units worked with electronic patient records.In only 45.5% of the units, patients were informed about available services, in 62% of the units the office hours were displayed to users, and the names and appointment hours for the attending healthcare professionals were available in 37% of the units.
Contributing factors listed as healthcare failures 8 (34%) were described as: drug treatment failures (mainly prescription errors); diagnostic errors; delay in diagnosis; delay in obtaining information and interpreting laboratory findings; failures in recognizing the urgency of the disease or its complications; and deficient staff knowledge.Participants recorded several suggestions on the questionnaires for improving care: implementation of electronic patient records, include a clinical pharmacist in the staff, continuing staff education, encouragement for a non-punitive culture, use of a support system for clinical decisions, clinical protocols, and staff involvement in strategies for implementing safe practice protocols.The nurse that answered questionnaire 102 stated: "When the health professionals converse and the work is integrated, discussing cases and evaluating problem situations, it is possible to avoid erroneous diagnostic interpretations, avoid blaming staff, and guarantee safer care for patients".The incident reporting system has been identified in the literature and by health authorities 28 as a mechanism capable of acting for quick correction of detected incidents.The system should be introduced as routine staff procedure, aimed at a safer culture.Even so, no participants in the current study mentioned it as a solution for the Brazilian context.

Final remarks
The theme of patient safety in promary health care has attracted increasing attention from the international health organizations 2 and from health systems in some developed countries, like Australia, United Kingdom, United States, and Portugal 29 .The theme has gained greater visibility in Brazil due to the National Program for Patient Safety 30 launched by the Brazilian Ministry of Health in 2013, which included primary health care as the locus for developing measures in patient safety improvement.Importantly, studies in this field are still incipient, and further research is needed.
The current study was one of the first to investigate incidents in primary health care in Brazil, and the results serve as relevant contributions to the field.
Adaptation of the PCISME questionnaire to the Brazilian context provided a specific instrument for measuring incidents in primary health care in the country, while calling attention to the harm occurring in these patients.Improvement of the questionnaire can help measure the frequency of patient care incidents and identify the contributing factors in Brazilian primary health care services.
The study showed that incidents are occurring in primary health care in a developing country like Brazil.Although the study was conducted in one health micro-region in the State of Rio de Janeiro, it may be representative of problems that occur elsewhere in the country.The fact that the findings are consistent with the literature suggests that they may be generalizable.
Resources such as strengthening teamwork with the inclusion of a pharmacist, support from information technology, continuing staff education, and involvement of patients appeared as important solutions in this field in both the field research and in the literature.An important challenge is awareness-raising of health policy-makers and health professionals for patient safety in primary health care.Difficulties with vulnerable patients are challenges for the system.The aim is to actively involve patients and their family in the process of care by providing them with information on safety measures and especially by giving them a voice in the process 31 .
According to experts from the Safer Primary Care project 32 , an important step for making care safer is the creation of an international information network, making the safety mechanisms for protecting patients in primary heaçth care known and applicable.Meanwhile, it is necessary to know and understand how cascades of errors lead to incidents.Incident reporting thus needs to be encouraged for such events to be investigated and to promote continuous learning to avoid incidents in the future.The creation of incident reporting systems is a way of collecting data that contribute to significant improvement in safety and quality of care.In order for such a system to be useful, it should be user-friendly, voluntary, and non-punitive, have safeguards for professional anonymity, be managed by trained personnel, and above all be a two-way mechanism 33 .
Strengthening a culture of safety among health professionals is an important conditioning factor for institutional development of strategies to improve quality and reduce incidents in primary health care.The study had some limitations: (i) there may have been low reporting of incidents due to some health care professionals' limited familiarity with the subject and the limited time for answering questionnaires; (ii) the results cannot necessarily be considered an expression of patient safety in primary health care as a whole, since this was a small convenience sample in one micro-region in one of Brazil's 27 states; and (iii) the reasons for incidents may have been underestimated due to the voluntary nature of incident reporting; Despite revision by a patient safety expert to improve precision in the types of incidents reported, there may have been erroneous description of some errors according to their consequences for the patient, while the actual cause may not have been reported in some cases because of the participants' time constraints, thus compromising the reports' reliability 28 .
Further research in this area should be part of Brazil's health policy agenda in order to ensure safer patient care.

Contributors
The three authors collaborated equally in conceiving, implementing, and reporting the study.

Table 1
General characteristics of 125 patients according to type of incident.

Table 2
Types of incidents, consequences for patient, contributing factors, and severity of harm.
complication Delay in delivering lab test.Laboratory far from patient's neighborhood (administrative failures) Adverse events Minimal harm Severe malnutrition Elderly patient unable to explain problem to physician.Lives alone, little schooling, no family support.Professional with little time for the consultation (communication failure with patient) Adverse events Minimal harm Complications of hypertension, required hospitalization Did not understand correct use of medication.Took wrong dose, can't read (communication failure with patient) Adverse events Minimal harm Medication did not produced desired effect in treatment of hypertension Lack of proper clinical follow-up of patient.Failure in staff training (patient care failures) Patient fails to take medication or eat when alone.Failure in family and caregiver support (failures in staff communication) Adverse events Minimal harm Intense headache The only specialist in the municipality failed to make the patient's diagnosis or conduct an adequate physical examination, and ignored the referral from the FHS.Full agenda, overconfident; fatigue (patient care failures) Fever, local pain, and edema Received wrong dose of vaccine due to error by nurse technician (patient care failures) Adverse events Minimal harm Complication of a respiratory allergy Patient failed to take medication.Shortage of medication in the pharmacy (administrative failures) (continues) Cad.Saúde Pública, Rio de Janeiro, 31(11):1-16, nov, 2015

Table 3
Proportion of types of errors that contributed to incidents detected in the Brazilian, Portuguese, and Australian studies.

Table 4
Place where errors occurred, in the Brazilian, Portuguese, and Australian studies.