Abstract Introduction Adverse drug reactions (ADRs) are an increasing health concern, causing considerable physical, psychological and economic impacts1,2. The yellow card scheme (YCS) is the UK’s spontaneous reporting system, allowing patients and healthcare professionals to report ADRs (3). Research has shown that patient reports could provide a beneficial insight into real-world situations and are a key aspect of pharmacovigilance2. Despite this, under-reporting by patients remains a significant issue that needs to be addressed1. Aim This study aimed to explore views and experiences of the public regarding ADR reporting. Methods Following approval from Cardiff University School of Pharmacy and Pharmaceutical Sciences Research Ethics Committee, adult members of the South Wales public who had experienced an ADR (“side-effect”) were invited via social media outlets such as Facebook and WhatsApp to participate in an online (Zoom) focus group to discuss their ADR experience (including whether they reported) and knowledge and views on the YCS. Healthcare professionals were excluded from the study. Written informed consent and demographic information via a short online survey were obtained prior to the focus group. The focus groups were audio and video recorded via Zoom and discussions were transcribed verbatim. A thematic analysis was executed to identify fundamental themes. Results Four focus groups, involving 11 participants took place. The sample consisted mostly of females between 18-30 years of age from an ethnic minority background. Themes identified were lack of knowledge of ADRs and the YCS; support and barriers to reporting ADRs and strategies for improving YCS reporting. There was a lack of knowledge of ADRs with uncertainty over the concept of “side-effect” and varying degrees of understanding on the topic. All participants had suffered side-effects that were severe in nature, affecting them physically, psychologically or cosmetically. None of the participants had any concept of the YCS and side-effect reporting. Despite this, participants felt reporting of side-effects was vital to ensure the safety of medications and prevention of patient harm. The majority of participants sought support for side-effects from a General Practitioner (GP) or community pharmacist, although difficulties accessing GP appointments was a barrier. Strategies suggested for increasing awareness of YCS to increase ADR reporting were use of posters, social media, QR codes, online prompts, coffee mornings and letters sent home to parents from schools. Discussion / Conclusion If patients are unsure around the concept of a side-effect and don’t know about the YCS, reporting rates will continue to fall. Although it is recognised that the sample is not fully representative of the Welsh population, this small-scale exploratory study has nevertheless identified some possible concerns but also some opportunities to engage patients in ADR reporting. Patient education by healthcare professionals on side-effects, alongside increased promotion of the YCS via social media and advertisements in healthcare settings are key opportunities to increase patients’ awareness and understanding of ADRs and ADR reporting. Further research is essential to understand the extent of these issues and also to investigate how healthcare professionals can facilitate this process. Follow-up studies are planned.
Read full abstract