title: Perceived barriers to reporting adverse drug events in hospitals: a qualitative study using theoretical domains framework approach.
abstract: BACKGROUND
  Adverse 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.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  A 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.
  
  
  CONCLUSIONS
  Detection 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.
authors.affiliation: Knowledge Utilization Research Center, Tehran University of Medical Sciences, No. 1547 North Karegar St, Enghelab Ave, Tehran, Iran. faribamirbaha@yahoo.com.
authors.forename: Fariba
authors.initials: F
authors.lastname: Mirbaha
authors.affiliation: Knowledge Utilization Research Center, Tehran University of Medical Sciences, No. 1547 North Karegar St, Enghelab Ave, Tehran, Iran. shalviri_g@yahoo.com.|Iranian Pharmacovigilance Center, Food and Drug Organization, No. 24, Daneshkian Ave. Vali Asr St., Tehran, Iran. shalviri_g@yahoo.com.
authors.forename: Gloria
authors.initials: G
authors.lastname: Shalviri
authors.affiliation: Knowledge Utilization Research Center, Tehran University of Medical Sciences, No. 1547 North Karegar St, Enghelab Ave, Tehran, Iran. byazdizadeh@tums.ac.ir.
authors.forename: Bahareh
authors.initials: B
authors.lastname: Yazdizadeh
authors.affiliation: Research Center for Rational Use of Drugs, Faculty of Pharmacy, Tehran University of Medical Sciences, No. 92, Karimkhane Zand Street, 1584775311, Tehran, Iran. khgholami@tums.ac.ir.
authors.forename: Kheirollah
authors.initials: K
authors.lastname: Gholami
authors.affiliation: Knowledge Utilization Research Center; Epidemiology and Biostatistics Department, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. rezamajd@tums.ac.ir.
authors.forename: Reza
authors.initials: R
authors.lastname: Majdzadeh
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D017144:Focus Groups; D006761:Hospitals / Q000706:statistics & numerical data*; D006801:Humans; D033182:Intention; D007492:Iran; D009042:Motivation; D010564:Personnel, Hospital / Q000523:psychology; D036301:Qualitative Research