Schäublin Martina
1 Swissmedic, Schweizerisches Heilmittelinstitut, Bern.
Ther Umsch. 2015 Dec;72(11-12):743-8. doi: 10.1024/0040-5930/a000746.
The aim of pharmacovigilance is to continuously update and enhance our knowledge about the safety of medicines in order to improve patient care. The most important method of postmarketing drug surveillance is the spontaneous reporting system. As a rapid alert system it is able to detect unknown and rare as well as insufficiently described reactions and risks. A broad population, including all potential high-risk groups, can be surveilled over a long period of time. The attentiveness of health care professionals as well as the quality and quantity of the information provided are crucial for the success of this system. As no detailed data concerning the number of patients taking a particular medication are available and only a small percentage of adverse drug reactions is reported, it is impossible to draw conclusions about the incidence of adverse drug reactions or the relative risk, which is a big disadvantage. Since 2002 healthcare professionals and pharmaceutical companies are obliged to report adverse drug reactions in accordance with the Swiss Therapeutic Products Act. Six Regional Pharmacovigilance-Centres collect health care professionals' reports, analyze them, enter the data into the national database and forward the anonymized reports to the National Pharmacovigiance-Centre at Swissmedic. There, all reports are screened for signals and, if necessary, appropriate measures are initiated. All reports received by Swissmedic are forwarded to the WHO Collaborating Centre for International Drug Monitoring (Uppsala, Sweden} for inclusion in the international database.
药物警戒的目的是持续更新和增进我们对药品安全性的了解,以改善患者护理。上市后药品监测的最重要方法是自发报告系统。作为一种快速警报系统,它能够检测未知、罕见以及描述不充分的反应和风险。可以对包括所有潜在高风险群体在内的广大人群进行长期监测。医疗保健专业人员的关注度以及所提供信息的质量和数量对该系统的成功至关重要。由于没有关于服用特定药物的患者数量的详细数据,而且只有一小部分药物不良反应被报告,因此无法得出药物不良反应的发生率或相对风险的结论,这是一个很大的缺点。自2002年以来,医疗保健专业人员和制药公司有义务根据瑞士治疗产品法案报告药物不良反应。六个地区药物警戒中心收集医疗保健专业人员的报告,进行分析,将数据输入国家数据库,并将匿名报告转发给瑞士药品管理局的国家药物警戒中心。在那里,所有报告都会进行信号筛选,如有必要,会采取适当措施。瑞士药品管理局收到的所有报告都会转发给世界卫生组织国际药品监测合作中心(瑞典乌普萨拉),以纳入国际数据库。