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

Mclernon, David J. and Bond, Christine and Lee, Amanda J. and Watson, Margaret C. and Hannaford, Philip C. and Fortnum, Heather and Krska, Janet and Anderson, Claire and Murphy, Elizabeth and Avery, Anthony (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). pp. 523-531. ISSN 1053-8569. (The full text of this publication is not currently available from this repository. You may be able to access a copy if URLs are provided)

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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.

Item Type: Article
Uncontrolled keywords: Adverse drug reaction reporting system, Patient, Personal narratives, Questionnaire, antiinfective agent, antineoplastic agent, antiparasitic agent, cardiovascular agent, central nervous system agents, dermatological agent, gastrointestinal agent, hematologic agent, insulin, sex hormone, adult, adverse drug reaction, aged, article, drug induced disease, drug surveillance program, education, experience, female, human, major clinical study, male, online monitoring, priority journal, questionnaire, United Kingdom, unspecified side effect, Adult, Adverse Drug Reaction Reporting Systems, Aged, Great Britain, Humans, Male, Middle Aged, Patient Participation, Pharmaceutical Preparations, Pilot Projects, Questionnaires, Sex Factors, Socioeconomic Factors
Subjects: R Medicine > RS Pharmacy and materia medica
Divisions: Faculties > Science Technology and Medical Studies > Medway School of Pharmacy
Depositing User: Janet Krska
Date Deposited: 19 Oct 2012 11:12
Last Modified: 11 Apr 2014 13:53
Resource URI: (The current URI for this page, for reference purposes)
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