Adverse Drug Reaction Reporting in the UK: A Retrospective Observational Comparison of Yellow Card Reports Submitted by Patients and Healthcare Professionals

Background: In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports. Objective: To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS. Design and Setting: Retrospective observational study in the UK. Methods: Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report. Results: In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range IQR ] of 3 [ 2 – 5 ] vs 2 [ 1 – 3 ], respectively; p