Czeizel A E
Foundation for Community Control of Hereditary Diseases, H-1026 Budapest, Törökvész lejt_32, Hungary.
Pharmacoepidemiol Drug Saf. 2001 Dec;10(7):635-9. doi: 10.1002/pds.635.
To discuss some ethical issues of the postmarketing surveillance of drug teratogenicity.
To describe the three study groups of the Hungarian Case-Control Surveillance of Congenital Abnormalities with the three sources of data collection.
This large population-based surveillance system comprised 22,843 cases with congenital abnormalities, 38,151 population controls without congenital abnormalities and 834 patient controls with Down syndrome between 1980 and 1996. The major ethical issue is connected with personal data protection (confidential handling of data and informed consent). However, the Hungarian experiences displayed the ethical dilemma between the balance of individual and community rights and interest (mandatory notification, mandatory autopsy of infant deaths, personal identification number). Finally the medical consequences of publication bias at the evaluation of drug teratogenicity are presented as these also have some ethical aspects.
The ethical issues of postmarketing surveillance of drug teratogenicity show similarities with general epidemiological research but this public health system also has some special aspects.
探讨药物致畸性上市后监测的一些伦理问题。
描述匈牙利先天性异常病例对照监测的三个研究组以及三种数据收集来源。
这个基于人群的大型监测系统在1980年至1996年间包括22843例先天性异常病例、38151例无先天性异常的人群对照以及834例唐氏综合征患者对照。主要伦理问题与个人数据保护（数据的保密处理和知情同意）有关。然而，匈牙利的经验显示了个人与社区权利和利益平衡之间的伦理困境（强制报告、婴儿死亡的强制尸检、个人识别号码）。最后，阐述了药物致畸性评估中发表偏倚的医学后果，因为这些也具有一些伦理方面。
药物致畸性上市后监测的伦理问题与一般流行病学研究有相似之处，但这个公共卫生系统也有一些特殊方面。
