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

David J McLernon, Christine M Bond, Amanda J Lee, Margaret C Watson, Philip C Hannaford, Heather Fortnum, Janet Krska, Claire Anderson, Elizabeth Murphy, Anthony Avery, Yellow Card Study Collaboration

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26 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)523-531
Number of pages9
JournalPharmacoepidemiology and Drug Safety
Volume20
Issue number5
DOIs
Publication statusPublished - May 2011

Keywords

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Aged
  • Drug-Related Side Effects and Adverse Reactions
  • Great Britain
  • Humans
  • Male
  • Middle Aged
  • Patient Participation
  • Pilot Projects
  • Sex Factors
  • Socioeconomic Factors
  • Surveys and Questionnaires

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    McLernon, D. J., Bond, C. M., Lee, A. J., Watson, M. C., Hannaford, P. C., Fortnum, H., Krska, J., Anderson, C., Murphy, E., Avery, A., & Yellow Card Study Collaboration (2011). Patient views and experiences of making adverse drug reaction reports to the Yellow Card Scheme in the UK. Pharmacoepidemiology and Drug Safety, 20(5), 523-531. https://doi.org/10.1002/pds.2117