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Study Summary

This research is about the reporting of suspected adverse drug reactions (“ADRs”) (also known as side effects) of a particular type of medicines taken by some patients, which are known as biologics. Adverse drug reactions are often serious enough to result in admission to hospital and consultations with General Practitioners. Adverse drug reactions place a significant burden on health services and account for patient deaths, disease and extra costs in the UK and worldwide.

The United Kingdom (“UK”) has a voluntary system of reporting suspected ADRs called the "Yellow Card Scheme". This scheme allows healthcare professionals and patients to submit reports to the UK medicines regulator. It is important to increase our understanding of reporting or underreporting of ADRs in patients to enable any problems to be addressed, to improve patient safety and public health. However, underreporting is known to be problem with these types of voluntary reporting systems and that is why there are major gaps in our understanding of why patients and healthcare professionals do or do not report suspected ADRs of biologics. For example, it is unknown or there is limited evidence on what the theoretical explanation is for reporting or the extent of underreporting of suspected ADRs to the UK’s Yellow Card Scheme and the reasons for it are also unknown and have not been studied, as far as known. Therefore, the study question is: What theory can explain out-patients and healthcare professionals’ perspectives on reporting or under-reporting of suspected ADRs of biologics to the UK’s Yellow Card Scheme?

The population to be studied are adult out-patients with arthritic conditions who have taken a biologic medicine and healthcare professionals (doctors, nurses and pharmacists) who look after these patients. Participants will be interviewed to explore their views on the issues being investigated. The study will be conducted on UK NHS hospital sites and take place between March 2023 and December 2023