Perceived barriers to reporting adverse drug events in hospitals: a qualitative study using theoretical domains framework approach

Abstract

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.

Applying the Theoretical Domains Framework to identify barriers and targeted interventions to enhance nurses’ use of electronic medication management systems in two Australian hospitals

“…The TDF has been used to identify barriers to implementing a range of practices with implications for patient safety including reporting adverse drug events in hospitals [46], reducing prescribing errors among trainee doctors [47], preventing misplaced nasogastric feeding tubes [44, 45], implementing stroke guideline recommendations [48], and encouraging hand hygiene practices [33]. …”

Pharmacovigilance Awareness among the Community Pharmacists and Pharmacy Students in the Turkish Republic of Northern Cyprus

“…Activities to improve the understanding and awareness of pharmacovigilance have been underway in Turkey since 2008, when a similar study to our own conducted in Istanbul, Turkey indicated "an urgent need for educational programs to train them about pharmacovigilance and ADR reporting. " which is a common problem faced by many countries [11][12][13]. The rates and attitudes towards ADR reporting, training programs should be improved for safety of public health.…”

Investigation of Factors Affecting Preparedness of Reporting Adverse Drug Reactions among Nurses in Public and Private Hospitals in Dar Es Salaam, Tanzania

“…ADRs reporting rate may be increased by overcoming the barriers because some of them can be solved through proper management and advertising of pharmacovigilance program such as distribution of reporting forms and appropriate guidelines hence making them widely available. The study by Mirbaha et al, identified six domains as relevant to barriers of ADRs reporting in hospitals [19]. These domains included some of the barrier observed in the current study such as "Knowledge", "Motivational factors and teamwork", Nonetheless, creating a closer relationship between nurses and ADRs reporting centers, providing nurses with proper reading materials as references to help them identify occurrence of adverse drug reactions, these can enormously enhance reporting performance.…”