Why hospital-based healthcare professionals do not report adverse drug reactions: a mixed methods study using the Theoretical Domains Framework

Abstract

Purpose Adverse drug reaction (ADR) underreporting is highly prevalent across the world. This study aimed to identify factors associated with ADR reporting and map these to a behavioural change framework to help inform future interventions designed to improve ADR underreporting. Methods A mixed methods survey was distributed to healthcare professionals at a tertiary hospital in Sydney, Australia. Quantitative data was analysed using logistic regression to identify factors that predict ADR reporting. Qualitative data was evaluated using content analysis. These were then integrated and mapped to the 14 domains within the Theoretical Domains Framework (TDF) to identify target areas relevant for improving ADR reporting. Results One hundred thirty-three healthcare professionals completed the survey. Knowing how to report ADRs (OR 4.56, 95%CI 1.95–10.7), having been trained on ADR reporting (OR 2.72, 95%CI 1.29–5.77), and encountering ADRs as part of clinical practice (OR 10.3, 95%CI 3.59–29.4) were significant predictors of reporting an ADR. Content analysis identified three categories: modifying the ADR reporting process, enabling clinicians to report ADRs, and creating a positive ADR reporting culture. After data integration, the three target TDF domains were knowledge, environmental context/resources, and beliefs about consequences. Conclusion Future interventions designed to improve ADR reporting should address these target domains to instigate behaviour change in healthcare professionals’ reporting of ADRs.

Barriers and Facilitators Influencing Real-time and Digital-Based Reporting of Adverse Drug Reactions by Community Pharmacists: Qualitative Study Using the Task-Technology Fit Framework

“…Other studies have discussed interventions to improve ADR reporting among health professionals in different countries [ 15 , 16 ]. However, it is important to note, the rationale for selecting these interventions may not have a theoretical base [ 16 , 23 ]. Therefore, it is necessary to understand the ADR reporting behavior of CPs using a well-defined theoretical approach [ 16 ].…”

Retrospective Analysis of Patient-Reported Adverse Drug Reactions in an Italian Allergy Unit: ALLERG-RAF Study

“…The evident absence of fatal events, observed in the present study, is another direct consequence of this choice. Although healthcare personnel represent the primary and most reliable source for recording ADRs, some studies show that there is underreporting by these professionals [28][29][30]. Based on this fact, the role of the patient is crucial.…”

Linking Activity Theory Within User-Centered Design: Novel Framework to Inform Design and Evaluation of Adverse Drug Reaction Reporting Systems in Pharmacy

“…A comprehensive multifaceted approach includes incorporating digital technologies with additional strategies that specifically address the key factors of a behavioral change framework [19]. The use of a behavioral change framework to investigate ADR reporting has previously been described [31,32]. As newer innovations emerge and digital technologies continue to transform health care management, several barriers still remain [33].…”

“…As newer innovations emerge and digital technologies continue to transform health care management, several barriers still remain [33]. A recent Australian study reported the use of a theoretical domains framework together with a technological intervention as a strategy to facilitate ADR reporting by clinicians in hospitals [19,31]. However, the perspective of pharmacists working in community pharmacies is lacking [18,21].…”

“…Prior studies to improve ADR reporting have not questioned the data-centric orientation of electronic reporting systems and have not explored systems shortcomings, or proposed ways to redesign reporting systems to facilitate reporting, complement clinical care while meeting the data needs of regulators [9,19]. Globally, studies have discussed interventions to improve ADR reporting among health professionals; however, the suggested interventions are of a general nature [9,16], without an evidence-based theoretical framework or adequate assessment of the end user needs [31,32]. An intervention applied in 1 setting may not be appropriate for another health setting, and there is therefore a need for an evidence-based method to guide the selection and implementation of relevant interventions [29,32].…”