Barriers and enablers affecting Yellow Card reporting in submissions in medicines information

Introduction: Only a fraction of adverse drug reactions (ADRs) are reported internationally, with between 3 to 7% of hospital admissions in the UK relating to ADRs, this underreporting is a patient safety concern. To embed Yellow Card (YC) reporting into the healthcare system, the Medicines and Healthcare products Regulatory Agency (MHRA) integrated reporting forms into clinical IT systems (e-YCs), including the pharmacy medicines information system, MiDatabank. Despite this technology, the MHRA received 49% fewer reports in 2021/22 compared with the previous year from MiDatabank in Scotland. There is a need to understand the barriers and enablers to MI staff reporting ADRs on e-YCs via MiDatabank, and behavioural theory will inform appropriate interventions to increase reporting rates via this route.

Method: MI centres in Scotland were asked to provide reports of the numbers of e-YCs submitted via MiDatabank, the total number of enquiries and the number of enquires categorised as relating to adverse events, between 2017 and 2022. MI staff in Scotland of all roles and experience, who use MiDatabank for MI enquiries with permission to complete e-YCs were invited to participate in this study. Semi-structured interviews were conducted between March and May 2023, using a Theoretical Domains Framework (TDF)-informed interview schedule to identify barriers and enablers of MI staff reporting ADRs on MiDatabank. Interviews were transcribed verbatim and thematically analysed inductively and deductively using NVivo software. Qualitative findings were mapped to the behaviour change wheel to identify appropriate interventions to address capability, opportunity and motivation.

Results: The highest reporting centre had an average of 20 e-YCs per annum over five years, which equates to a reporting rate average based on number of adverse events enquires of 22%. The lowest centre submitted no reports. Seven interviews were conducted with staff of differing roles and experience from five MI centres in Scotland. Professional role and identity, knowledge, belief about capabilities, memory attention and decision processes, and social influences were the most significant TDF domains influencing behaviour of MI staff in ADR reporting. Uncertainty about enquirer consent to report, knowledge and confidence about reporting based on suspicion, identifying ADRs within a clinical enquiry, and the belief that it’s the role of the patient-facing practitioner to submit e-YCs were barriers. There was mixed views on the functionality of e-YC reporting on MiDatabank. All participants who have used the e-YC integrated function (n=6) describe it as being easy, however some common themes for improvement emerged and hope for “better functionality for reporting” on MiDatabank.

Discussion: Reporting data confirmed variation existed in the number of e-YCs submitted annually across the six centres that provided data, suggesting there is scope for improvement. Interventions including education, persuasion, training, modelling and enablement may help address some of the barriers. A suite of interventions has been suggesting including peer discussion and support, adding YC reporting to MI team agendas, and increasing awareness of the national SOP for ADRs.