Schaefer Christof, Oppermann Marc, Wacker Evelin, Weber-Schoendorfer Corinna
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Charité - Universitätsmedizin Berlin, Berlin.
Z Evid Fortbild Qual Gesundhwes. 2012;106(10):723-8. doi: 10.1016/j.zefq.2012.11.012. Epub 2012 Nov 20.
In many countries drug risk classifications tend to create the impression of a high level of risk, leading healthcare professionals and consumers to overestimate the actual risk when seeking a drug of choice or estimating the risk of a past exposure during pregnancy. In addition, there are insufficient human data for the majority of drugs used by women of reproductive age to precisely assess their prenatal risk or safety. The Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy provides pertinent information in this field to healthcare professionals and pregnant women. After the initiation of a risk inquiry exposed pregnancies are followed through as to birth outcome and beyond. These follow-up data allow the detection of signals and the quantification of safety or risks for the unborn through evaluation in prospective cohort studies. Both a detailed risk characterisation and/or quantification of safety are essential to risk management after inadvertent drug exposure or when looking for a drug of choice. Individual consultations are available drawing on the results from the institute's own database and other working groups, and regularly updated information is also available via the open access database www.embryotox.de.
在许多国家，药物风险分类往往会给人一种高风险的印象，导致医疗保健专业人员和消费者在选择药物或评估孕期既往接触药物的风险时高估实际风险。此外，对于育龄妇女使用的大多数药物，缺乏足够的人体数据来精确评估其产前风险或安全性。柏林临床致畸学和药物孕期风险评估研究所为医疗保健专业人员和孕妇提供该领域的相关信息。在启动风险调查后，对暴露于药物的妊娠进行跟踪直至分娩结局及之后的情况。这些随访数据有助于通过前瞻性队列研究中的评估来检测信号并量化未出生胎儿的安全性或风险。对于意外药物暴露后或寻找首选药物时的风险管理而言，详细的风险特征描述和/或安全性量化都是必不可少的。可根据该研究所自身数据库及其他工作组的结果提供个体咨询服务，并且也可通过开放获取数据库www.embryotox.de获取定期更新的信息。
