Exploring the influencing factors of adverse drug reaction reporting among medical personnel: a COM-B model-based study.

Background: This study aims to identify the factors that influence medical workers' enthusiasm for reporting adverse drug reactions (ADRs). Understanding these factors is essential to implement targeted interventions that can improve and refine pharmacovigilance systems.

Methods: We adopted the Capability, Opportunity, Motivation, and Behavior model (COM-B) model as the theoretical framework and conducted qualitative research using in-depth interviews with clinicians, nurses, pharmacists, and administrators. 24 one-on-one interviews were conducted and audio-recorded. The interviews were transcribed verbatim, and subjected to thematic analysis to uncover the key factors affecting ADR reporting among medical staff.

Results: The participation included 24 healthcare workers from six different healthcare organisations. Analysis revealed that decreased motivation to report ADRs was due to inadequate judgment or inconsistent judgment criteria within the capability domain, poor awareness of ADRs and deficient communication skills within the psychological domain, unclear responsibilities within the motivation domain, and limited or no access to necessary resources within the opportunity domain. Facilitators of ADR reporting included sufficient cognitive and operational abilities, spontaneous and incentivized motivation, clear responsibilities and role expectations, and robust social support.

Conclusion: There is a critical need to develop comprehensive interventions that address the identified factors influencing ADR reporting. By improving the motivation of medical staff to report ADRs, the pharmacovigilance system can be significantly improved.