ORIGINAL ARTICLE DOI: http://dx.doi.org/10.

1590/S1980-220X2017026403346

Incidents reporting: barriers and strategies to promote safety culture*

Notificação de incidentes: barreiras e estratégias para promover a cultura de segurança
Notificación de incidentes: barreras y estrategias para promover la cultura de seguridad

Fabiana Rossi Varallo1, Aline Cristina Passos1, Tales Rubens de Nadai2, Patricia de Carvalho Mastroianni1

How to cite this article:

Varallo FR, Passos AC, Nadai TR, Mastroianni PC. Incidents reporting: barriers and strategies to promote safety culture. Rev Esc Enferm USP. 2018;52:e03346.
DOI: http://dx.doi.org/10.1590/S1980-220X2017026403346

*
Extracted from the final work: “Causas ABSTRACT
de subnotificação a eventos adversos no
Hospital Estadual Américo Brasiliense”,
Objective: The purpose was to identify the barriers of underreporting, the factors
Curso de Especialização em Saúde Pública, that promote motivation of health professionals to report, and strategies to enhance
Faculdade de Ciências Farmacêuticas, incidents reporting. Method: Group conversations were carried out within a hospital
Universidade Estadual Paulista, 2014. multidisciplinary team. A mediator stimulated reflection among the subjects about
1
Universidade Estadual Paulista, Faculdade the theme. Sixty-five health professionals were enrolled. Results: Complacency and
de Ciências Farmacêuticas, Campus ambition were barriers exceeded. Lack of responsibility about culture of reporting was the
Araraquara, Araraquara, SP, Brazil. new barrier observed. There is a belief only nurses should report incidents. The strategies
2
Hospital Estadual Américo Brasiliense, related to motivation reported were: feedback; educational intervention with hospital
Departamento de Cirurgia e Anatomia, Faculdade staff; and simplified tools for reporting (electronic or manual), which allow filling critical
de Medicina de Ribeirão Preto, Universidade information and traceability of management risk team to improve the quality of report.
de São Paulo, Ribeirão Preto, SP, Brazil. Conclusion: Ordinary and practical strategies should be developed to optimize incidents
reporting, to make people aware about their responsibilities about the culture of reporting
and to improve the risk communication and the quality of healthcare and patient safety.
DESCRIPTORS
Drug-related Side Effects and  Adverse  Reactions; Attitude of the Health Personnel;
Patient Safety; Safety Management; Adverse Drug Reaction Reporting Systems;
Pharmacovigilance.

Corresponding author:
Patricia de Carvalho Mastroianni
Universidade Estadual Paulista, Faculdade de
Ciências Farmacêuticas, Campus Araraquara
Rodovia Araraquara-Jaú, Km
1, s/n, Campus Ville
CEP 14800-903 – Araraquara, SP, Brazil Received: 07/12/2017
[email protected] Approved: 01/31/2018

www.ee.usp.br/reeusp Rev Esc Enferm USP · 2018;52:e03346 1

Incidents reporting: barriers and strategies to promote safety culture

INTRODUCTION Recruitment
Incident reporting is the main method of generating alert Invitation of all health professionals was carried out per-
signals concerning the provision of quality healthcare(1-2). sonally and up-to three times in each shift. Participation was
However, only 1% of incidents are reported by health profes- voluntary and with the approval by the Board of Directors.
sionals(3). The lack of information contributes to low effective-
ness of surveillance(4) and increases bias in epidemiologic com- Data collection
munication(5). This limits the development of safety measures. Group of conversations was performed by three research-
The reasons for underreporting are lack of time, unbelief ers with equal cultural competence and with experience in
in improvement, fear of reprisal(3), and that the observed
event has not caused serious harm to the patient(6). A sys- the issue (an expert in public health, a master and a PhD in
tematic review(7) also showed that lack of knowledge is a rea- Pharmaceutical Sciences). A mediator (ad hoc consulter with
son for underreporting of adverse drug events (ADEs). The a University affiliation) developed the discussions, motivat-
authors suggested a need for qualitative research to assess ing the employees to express their perceptions about the
the perception of health professionals related to the barriers “culture of reporting”.
of risk communication, as well as educational intervention With the aid of three questions, issues related to barriers
to increase awareness about the risk management services. of reporting, what are the factors related to motivation for
A multidisciplinary approach to drug-safety assessments reporting and the strategies to improve reporting of inci-
carried out in a general public hospital contributed to identifying dents were discussed among the groups.
new, relevant drug-related problems and improved the number Researchers performed annotation of discourses accord-
of ADE reports by 70-fold(8). However, 10.5% of adverse drug ing to information that represents the barriers related to
reactions remained unreported(9). Therefore, it is important to reporting, the motivations and strategies to improve them.
encourage health professionals to report incidents in order to
i) promote the identification of problems in a non-blaming Data analysis
manner, ii) enable self-assessment of healthcare practices, and
Barriers identified were classified according to seven
iii) allow the development of new professional and institutional
causes of underreporting(11): i) complacency (believing
structures to define the responsibilities and standards for patient
that serious ADRs are well documented when the drug is
safety as well as prepare management policies such as risk mini-
released on the market); ii) fear of becoming involved in a
mization plans(1-2). The present study aims to identify the causes
lawsuit or legal process; iii) guilt for having been respon-
related to the underreporting of incidents by health profession-
sible for the damage observed in the patient; iv) ambition
als, reasons that limit health professionals’ motivations to make
reports, and to propose strategies to increase the adherence of of the group to publish case series or benefit financially;
hospital care teams to risk management policies. v) ignorance of how to describe the reports (believing that
only serious and unexpected ADEs must be reported); vi)
METHOD insecurity about reporting suspicions of ADEs (belief that
there should be reports only if there is certainty that the
damage was caused by the use of specific medication);
Study design and vii) indifference due to lack of interest, time, or other
With a technique of group of conversation, health profes- excuses related to postponing the report of damage due
sionals were invited to discuss their experiences, perceptions and to drug use.
behavior about the practice and process of incidents reporting. Factors related to motivation and strategies to improve
We applied the guideline RATS to perform the study(10). incidents reports were described according to the suggestions
of health professionals.
Sampling and local
During the period of the study, the staff of hospital Ethical aspects
comprised 354 health professionals, who covered the follow
The study (protocol CAAE 35586714.8.0000.5426)
wards: intensive care unit (ICU), infectious diseases, internal
medicine and palliative care. was conducted in accordance with ethical statements of
All health professionals were invited to participate of the Ordinance 466/12. It was approved under the protocol
groups of conversations. Each group was formed with at least number 956.833 in 02/09/2015 by the Ethics Committee
one subject from each profession of a multidisciplinary health in Research of the School of Pharmaceutical Sciences of
team, which comprises social workers, nutritionists, physiother- UNESP-Araraquara (SP), Brazil.
apists, psychologists, pharmacists, pharmacy technicians, speech
therapists, occupational therapists, physicians, and nursing staff. RESULTS
Ten groups of conversation were held during the three According to the perceptions of health professionals, the
shifts, being four in the morning, four in the afternoon and two causes of underreporting incidents were indifference, diffi-
at night. Sixty-five volunteers were enrolled until the saturation dence, ignorance, and guilt for having been responsible for
of findings (when any new information was not observed or the incidents or for communicating them, whose coworker
reported). Discussions occurred in a room between the wards, was the responsible (Chart 1). The barriers of complacency
in order to facilitate the participation in the study. and ambition described previously(11) were not observed.

2 Rev Esc Enferm USP · 2018;52:e03346 www.ee.usp.br/reeusp

 Varallo FR, Passos AC, Nadai TR, Mastroianni PC

We noticed a new barrier related to the lack of account- reporting. There is a belief among them that just the nurse
ability of health professionals related to the culture of staff is responsible for reporting (Chart 1).

Chart 1 – Causes of underreporting according to the perceptions of health professionals from a public general hospital in the state
of São Paulo, 2017.

Causes Perceptions
GUILT There is a feeling of guilt for being responsible for the occurrence of an incident. Reports may indicate an inappropriate
practice during the healthcare procedures (“I could reveal inconsistencies).
Furthermore, professionals reported uncomfortable situations in reporting incidents by a coworker. The report would impair
the career of the colleague due to evidence of incompetence or negligence regarding institutional protocols (“I could reveal
the incompetence of my colleague with my report”).
IGNORANCE Ignorance is related to incident reporting (“I do not know what or how to report”, “I have no knowledge about what to
report”, “I do not know where to find the reporting form”, “I do not know where to send the reporting form”, “I did not know
that the multidisciplinary team can file reports”).
Moreover, several professionals report only serious incidents (“I report just the most serious incidents for patients”, “The
incident does not impact the patient in that moment, so I did not report it”, “If we solve the non-serious incidents , we do not
report them”), since reporting process wastes time, and healthcare is a priority when compared with filling out documents
(“Pharmacovigilance and technical surveillance reporting forms have a lot of information. Even if they were mostly ordinary
incidents, we would have to take time to fill them out”).
DIFFIDENCE A lack of causal evidence also leads to underreporting (“I am not sure about which drug was responsible for the incident”).
INDIFERRENCE The lack of feedback and the absence of the culture of reporting are important barriers (“Culturally, Brazilian professionals do
not file reports. I worked at another health institution and nobody filed reports there”, “I do not know what happens with my
report”, “I do not file reports because I do not see changes in my work routine”).
Complexity in filling out reporting forms is also a hindrance (“The reporting form is too long”, “The reporting form gives me
more work”). Besides filling out the form, incidents must be registered in medical records and in an institutional document
(“We must report incidents twice, which wastes my time and I have other priorities”).
LACK Nursing staff has the responsibility to file reports (“I identify the incident and communicate it to the nurse”, “Nursing staff
ACCOUNTABILITY must fill out the reporting form”). Therefore, responsibility always belongs to another person. However, nursing staff does not
file reports because they are overworked and have no time (“My commute is six hours, but I must manage 24 hours. Even if
other professionals identify the incident, I will forget to report it”).

Source: Elaborated by the authors. Note: (n=65).

The most frequent reason reported in association with is not a priority in clinical routine, and that the intention is
the motivation of reporting was a lack of knowledge about to establish blame. Therefore, strategies to stimulate reporting
the importance of incident reporting in generating indi- should clarify the meaning of incident reports in the context
cators. Reporting helps to develop strategies to improve of risk management and patient safety. Feasible and cost-ef-
defense barriers during healthcare procedures, as well as fective methods have been proposed in other hospitals(12).
institutional protocols aimed at patient safety and prevent- Our results matched with the findings of a systematic
ing new incidents. review(7), which also demonstrated that ignorance, diffi-
Therefore, in order to encourage spontaneous incidents dence, and indifference are the principal causes of under-
reporting, the following strategies were proposed: 1) brief reporting. Although the review included articles with
and in loco educational interventions emphasizing the flow cross-sectional design, the authors suggested that lack of
of reports in the institution, which would elucidate what to knowledge about reporting is an important factor that hin-
report as well as when and how to file one; 2) simplifica- ders adherence to risk management practices. The authors
tion and unification of the reporting form in order to allow also highlight the need of qualitative approaches to identity
patient identification, description of the incident, and input new barriers and strategies related to incidents reports.
data of the incident; 3) deployment of institutional risk man- Our study allows identifying that lack of responsibility of
health professionals is a problem to implement a culture
agement policies with clearly defined positions, assignments,
of reporting in health institutions that was not observed
and responsibility; 4) employment of a professional to collect
with other methods.
the reports and to follow up on the cases; and 5) feedback on
However, our data show that knowledge per se is insuffi-
the results obtained from the incident reports.
cient to promote changes in attitude and behavior. The same
paradox was noticed in Canada(13). Even if there is aware-
DISCUSSION ness about the importance of generating alerts, improving
According to the perceptions of health professionals, a the process, and preventing new adverse reactions, these
new barrier observed is the lack of accountability among advantages do not encourage professionals to report them.
health professionals according to the culture of reporting. This phenomenon can be explained by the effectiveness of
However, after 40 years of the events reported(11), four of them educational interventions over time. After the interven-
remain: guilt, indifference, diffidence, and ignorance. Data tions, the rate of adverse event reporting is enhanced for
show the need to change the misunderstanding that only four months(8,14-15). Therefore, periodic interventions should
serious incidents should be reported, that incidents reporting be performed to keep professionals motivated. However,

www.ee.usp.br/reeusp Rev Esc Enferm USP · 2018;52:e03346 3

Incidents reporting: barriers and strategies to promote safety culture

when different methods were applied to improve the report Furthermore, feedback on the results arising from spon-
of adverse drug reactions, it was observed that 10.5% of taneous reports should be provided to health professionals to
them were still unreported(9), despite the multifaceted edu- increase adherence to the voluntary monitoring of healthcare
cational intervention(8). Therefore, incentives are needed procedures. Owing to underreporting of adverse events is
for the development of strategies to improve the skills of associated with low use of technology(17), alerts generated by
professionals regarding the true meaning of adverse event health professionals should be published in 1) smartphone
reporting in the context of patient care and the evaluation applications (after prior authorization by the employee), 2)
of health technologies. This would enable cultural changes institutional bulletins on patient safety, or 3) the homepage
and redefine the expectations about risk management(12). and official social networks of the health facility so that the
To achieve these goals, the strategies listed by hospi- information can be accessed by anyone who is interested(18).
tal staff were brief, decentralized, and in loco educational Finally, further studies should be carried out to assess
interventions. This goes against the classical models of whether the proposed interventions are effective in changing
teaching and learning, in which knowledge is transferred the behaviors and attitudes of professionals as well as prior-
passively through lectures. According to subjects, interven- itizing and speeding up risk communication in the hospital
tions could be performed in their own work environments and improve the culture of reporting.
to demonstrate the impact of incidents reported to health Limitations of the study: as a qualitative study, the results
establishments and give guidance for filling out notifica- might not be reproducible in other settings or expanded
tion forms. The form should be reworded to allow agility beyond the subjects involved. However, it provides a clear
and prioritization of the notification. It was suggested that picture that could benefit the present hospital practice.
a unified electronic instrument should be established for
incident reporting, in which it would be possible to identify CONCLUSION
the incident, patient, and date of input. This would help to Complacency, fear of litigation, ambition to publish, and
minimize the barrier of indifference due to a lack of time ignorance are barriers to overcome which had hindered inci-
and the avoidance of bureaucratic paperwork. dents reporting. However, lack of accountability of health pro-
The adoption of simplified forms may help with quan- fessionals is a new factor related to underreporting. Knowledge
titative aspects, but it may be associated with incomplete of the importance of incidents reporting is considered a motiva-
information. The deployment of institutional risk manage- tion for increasing the adherence of professionals to monitoring,
ment policies with definitions of activities and responsi- but it is insufficient to increase attitude. Therefore, strategies
bilities could help to overcome this issue, since financial proposed to enhance spontaneous incident monitoring are
incentives fail to increase adherence to monitoring(16). establishment of minimal criteria to report which could allow
Therefore, a professional could be designated to collect traceability by a professional or risk management team who will
reports and to promote the follow up of each case in order to improve the quality of the information; and the tool of report be
increase the quality of information and contribute to causality incorporated in the instrument applied by health professionals
assessment.An on-site professional dedicated to reporting and during their assistance in clinical practice (without a new form
education could contribute to improving risk management(13). which promote interruptions in healthcare).

RESUMO
Objetivo: Identificar as barreiras da subnotificação, os fatores que motivam o relato e as estratégias para promover os registros de incidentes.
Método: Por meio de rodas de conversas e a presença de um mediador, a equipe multidisciplinar do hospital, composta por 65 profissionais,
foi estimulada a falar sobre tema. Resultado: Complacência e ambição são barreiras superadas. Falta de responsabilidade sobre notificação foi
a nova barreira observada. Há uma crença de que apenas a enfermagem é responsável pela notificação. Conclusão: As estratégias para motivar
os registros foram retornos das notificações relatadas (feedback), intervenções educativas na equipe de saúde, ferramentas simplificadas para
notificação (manual ou eletrônica), com informações mínimas necessárias para a equipe de saúde otimizar o processo e o tempo de notificação.
Para a garantia da qualidade do relato, a equipe de gerenciamento da segurança poderia melhorar ou complementar o relato.
DESCRITORES
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos; Atitude do Pessoal de Saúde; Segurança do Paciente; Gestão da
Segurança; Sistemas de Notificação de Reações Adversas a Medicamentos; Farmacovigilância.
RESUMEN
Objetivo: Identificar las barreras de la subnotificación, los factores que motivan el relato y las estrategias para promover los registros
de incidentes. Método: Mediante ruedas de conversación y la presencia de un mediador, el equipo multidisciplinario del hospital,
compuesto de 65 profesionales, fue estimulado a hablar acerca del tema. Resultado: Complacencia y ambición son barreras superadas.
Falta de responsabilidad acerca de la notificación fue la nueva barrera observada. Existe una creencia de que solo la enfermería es
responsable de la notificación. Conclusión: Las estrategias para motivar los registros fueron retornos de las notificaciones relatadas
(feedback), intervenciones educativas en el equipo sanitario, herramientas simplificadas para notificación (manual o electrónica), con
informaciones mínimas necesarias para que el equipo sanitario optimice el proceso y el tiempo de notificación. Para la garantía de la
calidad del relato, el equipo de gestión de la seguridad podría mejorar o complementar el relato.
DESCRIPTORES
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos; Actitud del Personal de Salud; Seguridad del Paciente;
Gestión de la Seguridad; Sistemas de Registro de Reacción Adversa a Medicamentos; Farmacovigilancia.

4 Rev Esc Enferm USP · 2018;52:e03346 www.ee.usp.br/reeusp

 Varallo FR, Passos AC, Nadai TR, Mastroianni PC

REFERENCES
1. World Health Organization. Conceptual framework for the international classification for patient safety. Version 1.1 [Internet]. Geneva:
WHO; 2009 [cited 2017 Jan 28]. Available from: http://www.who.int/patientsafety/implementation/taxonomy/icps_technical_report_en.pdf
2. Iedema R, Flabouris A, Grant S, Jorm C. Narrativizing errors of care: critical incident reporting in clinical practice. Soc Sci Med.
2006;62(1):134-44.
3. Howe CL. A review of the Office of Inspector General’s reports on adverse event identification and reporting. J Healthc Risk Manag.
2011;30(4):48-54. DOI: 10.1002/jhrm.20068
4. Howell AM, Burns EM, Bouras G, Donaldson LJ, Athanasiou T, Darzi A. Can patient safety incident reports be used to compare hospital
safety? Results from a quantitative analysis of the English national reporting and learning system data. PLoS One [Internet]. 2015 [cited
2017 Jan 28];10(12):e0144107. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674095/
5. Noble DJ, Pronovost PJ. Underreporting of patient safety incidents reduces health care’s ability to quantify and accurately measure harm
reduction. J Patient Saf. 2010;6(4):247-50.
6. Throckmorton T, Etchegaray J. Factors affecting incident reporting by registered nurses: the relationship of perceptions of the environment for
reporting errors, knowledge of the nursing practice act, and demographics on intent to report errors. J Perianesth Nurs. 2007;22(6):400-12.
7. Varallo FR, Guimarães SOP, Abjaude SAR, Mastroianni PC. Causes for the underreporting of adverse drug events by health professionals: a
systematic review. Rev Esc Enferm USP [Internet]. 2014 [cited 2017 Jan 28];48(4):739-47. Available from: http://www.scielo.br/pdf/reeusp/
v48n4/0080-6234-reeusp-48-04-739.pdf
8. Varallo FR, Planeta CS, Mastroianni PC. Effectiveness of pharmacovigilance : multifaceted educational intervention related to the
knowledge, skills and attitudes of multidisciplinary hospital staff. Clinics (Sao Paulo) [Internet]. 2017 [cited 2017 June 20];72(1):51-7.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5251201/
9. Varallo FR, Dagli-Hernandez C, Pagotto C, Nadai TR, Herdeiro MT, Mastroianni PC. Confounding variables and the performance of triggers
in detecting unreported adverse drug reactions. Clin Ther. 2017;39(4):686-96. DOI: 10.1016/j.clinthera.2016.11.005
10. Clark JP. How to peer review a qualitative manuscript. In: Godlee F, JeffersonT, editors. Peer review in health sciences. London: BMJ Books;
2003. p. 219-35.
11. Inman WHW. Assessment drug safety problems. In: Gent M, Shigmatsu I, editors. Epidemiological issues in reported drug-induced illnesses.
Honolulu, Ontario: McMaster University; 1976. p. 17-24.
12. Bäckström M, Mjörndal T, Dahlqvist R, Nordkvist-Olsson T. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin
Pharmacol. 2000;56(9-10):729-32.
13. Nichols V, Thériault-Dubé I, Touzin J, Delisle JF, Lebel D, Bussières JF, et al. Risk perception and reasons for noncompliance in
pharmacovigilance: a qualitative study conducted in Canada. Drug Saf. 2009;32(7):579-90. DOI: 10.2165/00002018-200932070-00004
14. Figueiras A, Herdeiro MT, Polónia J, Gestal-Otero JJ. An educational intervention to improve physician reporting of adverse drug reactions:
a cluster-randomized controlled trial. JAMA [Internet]. 2006 [cited 2017 Jan 28]; 296:1086–93. Available from: http://jamanetwork.com/
journals/jama/fullarticle/203253 DOI 10.1001/jama.296.9.1086
15. Ribeiro-Vaz I, Herdeiro MT, Polónia J, Figueiras A. Strategies to increase the sensitivity of pharmacovigilance in Portugal. Rev Saúde Pública
[Internet]. 2011 [cited 2017 Jan 28]; 45(1):129-35. Available from: http://www.scielo.br/pdf/rsp/v45n1/en_1771.pdf
16. Cereza G, Agustí A, Pedrós C, Vallano A, Aguilera C, Danés I, et al. Effect of an intervention on the features of adverse drug reactions
spontaneously reported in a hospital. Eur J Clin Pharmacol. 2010;66(9):937-45. DOI: 10.1007/s00228-010-0856-8
17. Edwards R. An agenda for UK clinical pharmacology: pharmacovigilance. Br J Clin Pharmacol. 2012;73(6):979-82. DOI: 10.1111/j.1365-
2125.2012.04249.x
18. Knezevic MZ, Bivolarevic IC, Peric TS, Jankovic SM. Using Facebook to increase spontaneous reporting of adverse drug reactions. Drug
Saf. 2011;34(4):351-2. DOI: 10.2165/11590110-000000000-00000

Financial support
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES). Scholarship (PDSE) grant no. 014301/2013-
00. Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). Project under grant #2013/10263-9. Programa
de Apoio ao Desenvolvimento Científico, Faculty of Pharmaceutical Sciences, Universidade Estadual Paulista.

This is an open-access article distributed under the terms of the Creative Commons Attribution License.

www.ee.usp.br/reeusp Rev Esc Enferm USP · 2018;52:e03346 5