Schaefer Christof
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Berlin, Germany.
Congenit Anom (Kyoto). 2011 Mar;51(1):6-11. doi: 10.1111/j.1741-4520.2010.00308.x.
Even though from preclinical testing to drug risk labeling, the situation with drugs in pregnancy has improved substantially since the thalidomide scandal, there is still an increasing need to provide healthcare professionals and patients with updated individualized risk information for clinical decision making. For the majority of drugs, clinical experience is still insufficient with respect to their safety in pregnancy. There is often uncertainty in how to interpret the available scientific data. Based on 20 years of experience with Teratology Information Services (TIS) cooperating in the European Network of Teratology Information Services (ENTIS) methods of risk interpretation, follow-up of exposed pregnancies through the consultation process and their evaluation is discussed. Vitamin K antagonists, isotretinoin and angiotensin (AT) II-receptor-antagonists are presented as examples of misinterpretation of drug risks and subjects of research based on observational clinical data recorded in TIS. As many TIS are poorly funded, advocacy is necessary by establishing contacts with decision makers in health politics and administration, informing them of the high return in terms of health outcomes and cost savings provided by TIS as reference institutions in clinical teratology.
尽管从临床前试验到药物风险标签，自沙利度胺丑闻以来，孕期用药的情况已有显著改善，但仍越来越需要为医疗保健专业人员和患者提供最新的个性化风险信息，以用于临床决策。对于大多数药物而言，其在孕期安全性方面的临床经验仍然不足。在如何解读现有科学数据方面往往存在不确定性。基于在欧洲致畸学信息服务网络（ENTIS）中合作开展的致畸学信息服务（TIS）20年的经验，本文讨论了风险解读方法、通过咨询过程对暴露妊娠进行随访及其评估。维生素K拮抗剂、异维A酸和血管紧张素（AT）II受体拮抗剂作为药物风险误读的示例以及基于TIS记录的观察性临床数据的研究对象进行了介绍。由于许多TIS资金不足，有必要通过与卫生政策和行政管理方面的决策者建立联系进行宣传，告知他们TIS作为临床致畸学参考机构在健康结果和成本节约方面的高回报。
