The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective
The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective
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DOI：
10.1111/j.1365-2125.2011.03990.x
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发表时间：
2011-11-01
影响因子：
3.4
通讯作者：
Avery, Anthony
中科院分区：
文献类型：
--
作者：
Anderson, Claire;Krska, Janet;Avery, Anthony
目的探讨英国黄卡计划(YCS)患者记者对该计划重要性的意见。方法在2008年3月至12月期间，我们代表我们向所有向药品和医疗保健管理署(MHRA)提交黄卡的患者记者分发了邮寄问卷，并向无响应者发出了一份后续提醒。对一个公开问题的回答进行了定性分析，该问题询问为什么受访者认为患者报告很重要。结果从2008年收回的1362份可评估问卷中，共有1238份(91%)受访者提供了1802条意见。进行了27次访谈，支持并扩大了问卷中表达的观点。出现了四个主要主题，表明YCS对一般药物警戒、制造商和发牌当局、患者、公众和卫生专业人员至关重要。记者们认为YCS是一个重要的机会，可以描述他们的经验，造福他人，并为药物警戒做出贡献。该计划独立于卫生专业人员被认为是重要的，部分是为了向制造商和监管机构提供患者的观点，但也是因为卫生专业人员的轻视态度和报告不足。结论使用该计划的人认为通过YCS直接报告患者情况很重要，以便为药物警戒提供患者体验，作为与卫生专业人员的独立观点。
AIMTo explore the opinions of patient reporters to the UK Yellow Card Scheme (YCS) on the importance of the scheme.METHODSPostal 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.RESULTSThere 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.CONCLUSIONDirect 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.