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监管机构、药品信息和互联网:欧洲视角。

Regulatory agencies, pharmaceutical information and the Internet: a European perspective.

机构信息

Max-Weber-Institute of Sociology, University of Heidelberg, Germany.

出版信息

Health Policy. 2012 Jan;104(1):12-8. doi: 10.1016/j.healthpol.2011.10.009. Epub 2011 Nov 17.

DOI:10.1016/j.healthpol.2011.10.009
PMID:22101089
Abstract

The Internet facilitates access to health information and can therefore support the effectiveness of healthcare provision and empower patients in healthcare decisions. In the field of pharmaceutical therapy the electronic provision of information can improve compliance and strengthen the general understanding of pharmaceutical risks and benefits. Current political developments in Europe encourage a stronger role of the pharmaceutical industry in this regard. In light of potential conflicts inherent to the private provision of information and given their public health mandate, regulatory bodies in the pharmaceutical sector may represent an important alternative source of information. The explorative analysis in this paper reviews the websites of European pharmaceutical regulatory agencies regarding the usability and provision of information from a Layman's perspective. It is found that while the majority of agencies do provide product-related information, the usability of websites from the lay perspective is subject to variation. The reluctant position of agencies can be attributed to sectoral path dependencies, the regulatory approach and a lack of regulatory resources.

摘要

互联网为获取健康信息提供了便利,因此可以支持医疗服务的有效性,并使患者能够在医疗决策中发挥更大作用。在药物治疗领域,电子信息的提供可以提高患者的依从性,增强他们对药物风险和收益的总体理解。当前欧洲的政治发展鼓励制药行业在这方面发挥更大作用。鉴于私人提供信息所固有的潜在冲突,以及它们的公共卫生任务,制药部门的监管机构可能代表着信息的一个重要替代来源。本文的探索性分析从非专业人士的角度,对欧洲制药监管机构的网站在可用性和信息提供方面进行了评估。结果发现,虽然大多数机构确实提供了与产品相关的信息,但从非专业人士的角度来看,网站的可用性存在差异。机构的不情愿态度可以归因于部门的路径依赖、监管方法和缺乏监管资源。

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