Cobert B, Silvey J
Schering-Plough Research Institute, Kenilworth, NJ 07090, USA.
Drug Saf. 1999 Feb;20(2):95-107. doi: 10.2165/00002018-199920020-00001.
Use of the Internet is becoming widespread throughout the world. Its use in the domain of drug safety and pharmacovigilance is spreading rapidly. Governments and industry have taken the lead in developing extensive web sites. The US Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other agencies have developed sites containing enormous amounts of information both on pharmacovigilance in general and on specific drugs in particular. Under the US 'Freedom of Information Act' the FDA has put major parts of its adverse event database on line. Regulatory documents are also available from the FDA site or from hyperlinks described in the site. The US Center for Drug Evaluation and Research updates its site most days and maintains a free automated e-mail announcement service of these updates. Similarly, the EMEA updates its site frequently and publishes extensive material including regulatory documents, guidelines, European Public Assessment Reports on newly approved medications and other useful information. A free update service by e-mail is also available. Although English is the primary language used on the EMEA site, some of the information is available in other languages. Pharmaceutical companies are not using the Internet for pharmacovigilance yet. Rather, the Internet is being used for promotion of their products and for informing consumers on general information on diseases, for financial and investor data and for employment opportunities, etc. Other organisations such as lobbies, consumer groups and medical journals are also beginning to use the Internet. The electronic transmission of safety information, using the standards developed by the International Conference on Harmonization, is currently being tested for the transmission of individual patient adverse event information between companies and governments. In addition, the FDA has begun to accept adverse events from healthcare providers and consumers directly on line using an electronic version of its MedWatch form. It is expected that these developments will change the nature of the way pharmacovigilance is carried out. Significant issues will arise from this including privacy concerns. The European Union's 1995 directive on 'the protection of individuals with regard to the processing of personal data and on the free movement of such data (95/46/EC)' went into effect in October 1998. The enabling legislation now being passed by the member states will produce significant changes in the way companies and governments handle individual patient data in order to assure the privacy and protection of individuals.
互联网的使用在全球正变得日益广泛。其在药物安全和药物警戒领域的应用正在迅速普及。政府和企业率先开发了大量网站。美国食品药品监督管理局（FDA）、欧洲药品评估局（EMEA）以及其他机构都已开发出网站，其中包含了关于药物警戒总体情况以及特定药物详细信息的海量内容。根据美国的《信息自由法案》，FDA已将其不良事件数据库的主要部分放到了网上。监管文件也可从FDA网站或该网站所描述的超链接获取。美国药品评价与研究中心多数日子都会更新其网站，并提供这些更新内容的免费自动电子邮件通知服务。同样，EMEA也会频繁更新其网站，并发布大量资料，包括监管文件、指南、关于新批准药物的欧洲公共评估报告以及其他有用信息。也提供电子邮件免费更新服务。虽然英语是EMEA网站使用的主要语言，但部分信息也有其他语言版本。制药公司尚未将互联网用于药物警戒。相反，互联网正被用于产品推广、向消费者提供疾病一般信息、财务和投资者数据以及就业机会等。其他组织，如游说团体、消费者团体和医学期刊也开始使用互联网。目前正在测试使用国际协调会议制定的标准进行安全信息的电子传输，以便在公司和政府之间传输个体患者不良事件信息。此外，FDA已开始通过其MedWatch表格的电子版直接在线接受医疗保健提供者和消费者上报的不良事件。预计这些发展将改变药物警戒的实施方式。由此将引发重大问题，包括隐私问题。欧盟1995年关于“个人数据处理及此类数据自由流动方面对个人的保护（95/46/EC）”的指令于1998年10月生效。成员国目前正在通过的授权立法将使公司和政府处理个体患者数据的方式发生重大变化，以确保个人隐私和得到保护。
