In a recent multi-centre NHS hospitals research case study, a new theory called "Pragmatic Situational Practice Outcomes" was developed to help understand the factors that influence whether rheumatology patients and healthcare professionals report suspected adverse drug reactions (ADRs), associated with biologic medications, to the UK Yellow Card Scheme, the current formal system for reporting suspected ADRs.
The study involved interviews with healthcare professionals (i.e. doctors, pharmacists, and nurses), as well as outpatients living with inflammatory arthritis who have been treated with biologics.
The theory defines key concepts that shape reporting behaviour, in particular, the practical considerations that guide decisions - a pragmatic approach; the circumstances and context of healthcare professionals and patients - a situational aspect; the actions and interactions involved in reporting suspected ADRs - a practice component; and finally, the expected consequences of the reporting itself - the outcomes.
According to the theory, patients and healthcare professionals must adopt a pragmatic approach to navigate their complex situational circumstances, which in turn shapes their practice and the outcomes they ultimately achieve -including whether they report or underreport suspected ADRs. In addition, patients may be hesitant to report if they are not encouraged to do so by healthcare professionals. Both healthcare professionals and patients may prioritise reporting suspected ADRs, while considering other reporting options beyond the formal Yellow Card Scheme.
The researcher Gary Greer says: ‘This new theory provides a detailed analysis of the factors that influence the reporting of suspected adverse drug reactions to the UK Yellow Card Scheme. This study offers insights into the situational and contextual conditions affecting reporting, which were previously unclear. The theory can guide policy development and practice changes, such as providing better advice and reminders to patients, which could enhance reporting rates.
Furthermore, despite decades of literature, there has been a lack of in-depth theoretical understanding of the complexities surrounding ADR reporting. This research identifies specific barriers, like knowledge gaps and time constraints, and highlights that addressing these barriers can lead to improved reporting behaviour among healthcare professionals and patients. It would be great to test this theory in future international studies to validate its applicability beyond the UK context.'