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

B O' Donovan, Ruth M Rodgers, Anthony R Cox, Janet Krska

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)
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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.

Original languageEnglish
Pages (from-to)1237-1243
Number of pages11
JournalExpert Opinion on Drug Safety
Issue number12
Early online date20 Sept 2019
Publication statusPublished - Dec 2019


  • Patient reports
  • adverse drug reactions
  • side effects
  • patient experience
  • Yellow Card Scheme
  • pharmacovigilance


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