Making medicines safer: analysis of patient reports to the UK's Yellow Card Scheme

Objectives: No studies describing UK patient Yellow Card reports have been published since the evaluation of the first two years of direct patient reporting (2005-7), when 5,180 reports were analyzed.

Methods: Patient Yellow Card reports submitted July-December 2015 for vaccines and other drugs were analyzed. Comparisons to the initial evaluation were made of: reporting method, number of suspect drugs, proportion classed as serious. Factors affecting seriousness of reports were examined.

Results: There were 3,060 patient Yellow Card reports analyzed. Vaccine reports have increased from very few in 2005-7 to 25% of reports. The proportion of reports citing one drug (94.3%) and the proportion considered serious (70.3%) increased from the 84% and 58% respectively found in 2005-7. The main method of reporting had changed from paper (61%) to internet (88.5%). Serious reports were more common in females, for vaccines in young persons, but in adults for other drugs, and included more reaction terms than non-serious reports.

Conclusion: Patient reporting, in particular to vaccines, has increased dramatically since 2005-7. Increases in the proportion of reports concerning one drug and the proportion considered serious could indicate that the usability of patient reports may have improved in comparison to early reporting.