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

ABSTRACT

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.

KEYWORDS:

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

Acknowledgments

The authors acknowledge the support of Rebecca Owen and Mitul Jajada from the MHRA in providing and clarifying data and reviewing the manuscript.

Author contributions

Conception and design (all authors), analysis and interpretation of the data (J Krska, R Rodgers and B O’ Donovan), drafting and revising of the paper (J Krska, A Cox and B O’ Donovan), revising, final approval (J Krska, A Cox and B O’ Donovan); and all authors agreed to be accountable for all aspects of the work.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This study was funded by the Medway School of Pharmacy.