Medical Statistics Team, Section of Population Health, University of Aberdeen, Aberdeen, UK.
Pharmacoepidemiol Drug Saf. 2011 May;20(5):523-31. doi: 10.1002/pds.2117. Epub 2011 Feb 17.
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.
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.
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.
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.
描述向英国黄卡计划(YCS)报告的患者报告者的特征和报告的可疑药物,并确定患者对提出黄卡报告的看法和体验。
为了向在 2008 年 3 月至 2009 年 1 月期间通过 YCS 报告的所有患者分发调查问卷,由药品和保健产品监管局(MHRA)开发。使用 Pearson 卡方检验检查报告方法(在线,邮寄和电话)与问卷答复之间的关联。
在 2008 名报告者中有 1362 名(68%)报告了可评估的问卷。应答者的中位数(IQR)年龄为 56.5(43.0,67.0)岁,910 名(66.8%)为女性,1274 名(93.5%)为白人,923 名(67.8%)具有至少进一步的教育资格。最常见的报告方法是邮寄(59.8%),其次是在线(32.8%)和电话(6.3%)。在线报告者比其他报告者年龄更小,教育程度更高。大多数受访者(n = 1274;93.6%)认为报告非常容易或容易完成,尽管许多人认为系统需要改进。三分之一(n = 448;32.9%)期望从 MHRA 获得反馈,而 828(60.8%)希望获得反馈。几乎所有受访者(n = 1302;95.6%)将再次报告。
大多数患者认为当前报告可疑 ADR 的方法易于使用,并会向他人推荐。不同的报告方法被不同的报告者人口统计学亚组使用。可以对系统进行改进,包括向报告者提供反馈。