[药物不良反应：通过患者协会进行患者报告的一项试点研究]
[Adverse drug reactions: a pilot study on patient reporting through patient associations].
作者信息
Nasrallah-Irles Daphney, Castot Anne, Thomas Laure, Babai Samy, Delorme Bernard, Le-Louët Hervé
机构信息
Afssaps, Service de l'Evaluation et de la Surveillance du Risque et de l'Information sur les Médicaments, Saint-Denis, France.
出版信息
Therapie. 2008 Sep-Oct;63(5):385-92. doi: 10.2515/therapie:2008060. Epub 2009 Jan 21.
BACKGROUND
The expected evolution of monitoring systems for health products, aims at increasing the involvement of patients into health products safety system. As a result, it seems necessary to consider the ability for patients to directly report their own adverse events.
METHODS
A pilot study has been undertaken by Afssaps (Health Agency) for 23 patient associations using a reporting form specially created for patients.
RESULTS
According to the analysis of the first 200 reports, received from June 2006 to August 2007, the reported adverse events are mostly serious in terms of consequences on patients' quality of life and expected. The quality of information shows that the proposed tools are adequate and could be used in case of a future change in legislation allowing patient reporting of adverse events.
CONCLUSION
The patient, eventually helped by his association, may provide contributory safety information, especially regarding side effects affecting daily life.
背景
保健产品监测系统的预期发展目标是让患者更多地参与到保健产品安全体系中。因此，考虑患者直接报告自身不良事件的能力似乎很有必要。
方法
法国卫生安全与健康产品局（Afssaps）针对23个患者协会开展了一项试点研究，使用的是专门为患者设计的报告表格。
结果
根据对2006年6月至2007年8月收到的首批200份报告的分析，就对患者生活质量的影响而言，所报告的不良事件大多较为严重且在意料之中。信息质量表明所提议的工具是足够的，并且在未来立法允许患者报告不良事件时可加以使用。
结论
患者最终在其协会的帮助下，可能会提供有价值的安全信息，尤其是关于影响日常生活的副作用方面的信息。
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