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Pharmacoepidemiol Drug Saf. 2011 May;20(5):523-31. doi: 10.1002/pds.2117. Epub 2011 Feb 17.

Patient views and experiences of making adverse drug reaction reports to the Yellow Card Scheme in the UK.

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  • 1Medical Statistics Team, Section of Population Health, University of Aberdeen, Aberdeen, UK. d.mclernon@abdn.ac.uk

Abstract

PURPOSE:

To describe the characteristics of patient reporters to the UK's Yellow Card Scheme (YCS) and the suspect drugs reported, and to determine patient views and experiences of making a Yellow Card report.

METHODS:

A questionnaire was developed for distribution by the Medicines and Healthcare products Regulatory Agency (MHRA) to all patients reporting through the YCS between March 2008 and January 2009. Associations between reporting method (online, postal and telephone) and questionnaire responses were examined using Pearson's Chi-squared test.

RESULTS:

Evaluable questionnaires were returned by 1362 out of 2008 reporters (68%). Respondents' median (IQR) age was 56.5 (43.0, 67.0) years, 910 (66.8%) were female, 1274 (93.5%) were white and 923 (67.8%) had at least a further education qualification. The most frequent reporting method was postal (59.8%), followed by online (32.8%) and telephone (6.3%). Online reporters were younger with a higher education level than those using other reporting methods. Most respondents, 1274 (93.6%), thought that the report was fairly or very easy to complete, although many identified the need for improvements to the system. One third (n = 448; 32.9%) expected feedback from the MHRA and 828 (60.8%) would have liked feedback. Almost all respondents (n = 1302; 95.6%) would report again.

CONCLUSIONS:

The majority of patients found the current methods of reporting suspected ADRs easy to use and would recommend them to others. Different methods of reporting were used by different demographic subgroups of reporters. Improvements to the system, including the provision of feedback to reporters, could be made.

Copyright © 2011 John Wiley & Sons, Ltd.

[PubMed - indexed for MEDLINE]
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