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Implementation Science

, 10:110

First Online: 07 August 2015Received: 20 January 2015Accepted: 30 July 2015DOI: 10.1186-s13012-015-0302-5

Cite this article as: Mirbaha, F., Shalviri, G., Yazdizadeh, B. et al. Implementation Sci 2015 10: 110. doi:10.1186-s13012-015-0302-5


BackgroundAdverse drug events ADEs are a major source of morbidity and mortality, estimated as the forth to sixth cause of annual deaths in the USA. Spontaneous reporting of suspected ADEs by health care professionals to a national pharmacovigilance system is recognized as a useful method to detect and reduce harm from medicines; however, underreporting is a major drawback. Understanding the barriers to ADE reporting and thereafter design of interventions to increase ADE reporting requires a systematic approach and use of theory. Since multiple theories in behavior change exist that may have conceptually overlapping constructs, a group of experts suggested an integrative framework called theoretical domains framework TDF. This approach considers a set of 12 domains, came from 33 theories and 128 constructs, covering the main factors influencing practitioner behavior and barriers to behavior change. The aim of this study is to apply TDF approach to establish an evidence-based understanding of barriers associated with ADE reporting among nurses and pharmacists.

MethodsA total of three focus group discussions were conducted; among them two consisted of nurses and one involved pharmacists. Discussions were guided by questions designed based on TDF. Transcriptions of discussions were then thematically analyzed, and detected barriers to reporting ADEs were categorized based on extracted themes.

ResultsA total of 34 nurses and pharmacists attended the group discussions. Six domains were identified to be relevant to barriers of ADE reporting in hospitals. These domains included -Knowledge,-Skills,-Beliefs about consequences,-Motivation and goals intention,-Social influences norms,- and -Environmental constraints.- We detected several barriers to ADE reporting, such as lack of knowledge of what should be reported, fear of punishment and criticism, lack of time, lack of teamwork, and lack of active support by hospital managements and other colleagues.

Based on detected barriers -Cognitive and behavioral factors,-Motivational factors and teamwork,- in addition to -Organizational processes and resources- could be targeted in designing appropriate interventions.

ConclusionsDetection of barriers to reporting ADEs is necessary to design appropriate interventions. The TDF is a comprehensive approach that enables us to better understand barriers to behavior change in reporting ADEs.

AbbreviationsADEadverse drug event

ADRadverse drug reaction

DSODrug Safety Officer

FGDfocus group discussion

IPCIranian Pharmacovigilance Center

KTEKnowledge Translation and Exchange

MEmedication error

TDFtheoretical domains framework

WHOWorld Health Organization

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Autor: Fariba Mirbaha - Gloria Shalviri - Bahareh Yazdizadeh - Kheirollah Gholami - Reza Majdzadeh


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