Abstract
Background: Direct reporting of suspected adverse drug reactions (ADRs) to authorities is increasing, but questions remain about how patients identify suspected ADRs and their ability to distinguish between ADRs and other symptoms.
Objective: The aim of the study was to determine how reporters to the Yellow Card Scheme (YCS) identify ADRs.
Methods: We carried out a qualitative analysis of data from three sources, obtained as part of a larger evaluation of patient reporting to the UK YCS: responses to open questions in postal questionnaires sent to all reporters during March 2008–January 2009 (method 1); telephone interviews with a purposive sample of these reporters (method 2); and the free-text field from completed Yellow Card reporting forms submitted during October 2005–September 2007 (method 3).
Results: Method 1 involved 1362 questionnaire respondents (67.8% of the 2008 patient reporters during the study period), 1167 of whom explained how they decided they had experienced an ADR. Temporality was the most common reason for the perceived association, given by 820 (70.2%) respondents. 478 (41.0%) provided information on two or more aspects of temporality, such as onset, changes with dose and re-challenge. A total of 383 (32.8%) respondents used information sources, such as patient information leaflets or discussions with health professionals to confirm associations, including 145 (12.4%) who had also reported a temporal association.
Telephone interviews with 27 reporters (method 2) provided detailed explanations of temporal associations, particularly experiences of rechallenge, and data from 230 Yellow Card reports (method 3) showed that, although reporters are not required to explain reasons for their suspicions, 74.8% of submitted reports included a temporal association. These reports also showed evidence of causal theorizing and differential diagnosis.
Conclusion: In our study sample, most reporters to the YCS feel able to identify suspected ADRs adequately and describe processes of assessing causality that mirror those in standard algorithms designed for use by health professionals. These findings should help to reduce concerns among health professionals about the ability of patients to identify suspected ADRs when reporting to authorities.
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Acknowledgements
This project was funded by the UK NHS R&D Programme Health Technology Assessment Programme (project number 06/92/03). The funding body had no input into the study or drafting of the paper. We are grateful to the MHRA for distribution of questionnaires and providing Yellow Cards for analysis, and also to all questionnaire respondents. Tim Payne and Alison Gifford conducted the interviews, supported administratively by Clare Randall, and Julia Taylor assisted with analysis of questionnaire responses.
All authors contributed to the design of the questionnaire, together with others from the Yellow Card Study Group, which includes Anthony J. Avery, Claire Anderson, Christine M. Bond, Heather Fortnum, Alison Gifford, Philip C. Hannaford, Lorna Hazell, Janet Krska, Amanda J. Lee, David J. McLernon, Elizabeth Murphy, Saad Shakir and Margaret C. Watson.
Janet Krska undertook the qualitative analysis of the questionnaire data, Claire Anderson and Elizabeth Murphy analysed the interviews and Yellow Card data, and Anthony Avery performed the quantitative analysis of the Yellow Card Data. Janet Krska and Claire Anderson drafted the article, to which all authors contributed. All members of the study group designed the overall study. Janet Krska is guarantor for the paper.
All authors had financial support from the UK NHS R&D Programme Health Technology Assessment Programme for the submitted work. They had no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work.
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Krska, J., Anderson, C., Murphy, E. et al. How Patient Reporters Identify Adverse Drug Reactions. Drug-Safety 34, 429–436 (2011). https://doi.org/10.2165/11589320-000000000-00000
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DOI: https://doi.org/10.2165/11589320-000000000-00000