University of Nottingham, Nottingham, UK.
Br J Clin Pharmacol. 2011 Nov;72(5):806-22. doi: 10.1111/j.1365-2125.2011.03990.x.
To explore the opinions of patient reporters to the UK Yellow Card Scheme (YCS) on the importance of the scheme.
Postal questionnaires were distributed on our behalf to all patient reporters submitting a Yellow Card to the Medicines and Healthcare Regulatory Agency (MHRA) between March and December 2008, with one follow-up reminder to non-responders. Qualitative analysis was undertaken of responses to an open question asking why respondents felt patient reporting was important. This was followed up by telephone interviews with a purposive sample of selected respondents.
There were 1362 evaluable questionnaires returned from 2008 distributed (68%) and 1238 (91%) respondents provided a total of 1802 comments. Twenty-seven interviews were conducted, which supported and expanded the views expressed in the questionnaire. Four main themes emerged, indicating views that the YCS was of importance to pharmacovigilance in general, manufacturers and licensing authorities, patients and the public and health professionals. Reporters viewed the YCS as an important opportunity to describe their experiences for the benefit of others and to contribute to pharmacovigilance. The scheme's independence from health professionals was regarded as important, in part to provide the patient perspective to manufacturers and regulators, but also because of dismissive attitudes and under-reporting by health professionals.
Direct patient reporting through the YCS is viewed as important by those who have used the scheme, in order to provide the patient experience for the benefit of pharmacovigilance, as an independent perspective from those of health professionals.
探讨患者报告者对英国黄卡计划（YCS）的看法，即该计划的重要性。
我们代表药品和保健产品监管局（MHRA）向所有在 2008 年 3 月至 12 月期间向 MHRA 提交黄卡的患者报告者分发了邮寄问卷，并对未回复者进行了一次后续提醒。对一个开放式问题的回答进行了定性分析，该问题询问受访者认为患者报告为何重要。随后，对选定的受访者进行了有针对性的电话访谈。
共发放了 2008 年分发的 1362 份可评估问卷（68%），1238 名（91%）受访者共提供了 1802 条意见。进行了 27 次访谈，这些访谈支持并扩展了问卷中表达的观点。出现了四个主要主题，表明了受访者认为 YCS 对一般药物警戒、制造商和许可当局、患者和公众以及卫生专业人员非常重要。报告者认为 YCS 是一个重要的机会，可以描述他们的经验，为药物警戒做出贡献，为他人谋福利。该计划独立于卫生专业人员被认为很重要，部分原因是向制造商和监管机构提供患者的观点，也因为卫生专业人员的不屑一顾和漏报。
通过 YCS 进行直接的患者报告被那些使用过该计划的人视为重要的，以便为药物警戒提供患者的经验，作为卫生专业人员观点的独立视角。
