Abstract：
Pharmaceutical residues are widely detected in aquatic environment worldwide mainly arising from human excretions in sewage systems. Presently, publicly available, high quality environmental risk assessment (ERA) data for pharmaceuticals are limited. However, databases like the Swedish Fass offer valuable resources aiding healthcare professionals and environmental scientists in identifying substances of significant concern. In this review, we provide a concise overview of the regulatory ERA process for medicinal products intended for human use. We explore its key assumptions and uncertainties using a subset of 37 pharmaceuticals. First, we compare the consistency of their predicted no-effect concentrations reported in the Fass database with those by marketing authorisation holders. Second, we compare the predicted environmental concentrations (PEC) calculated based on sales data between European and national drug consumption statistics as well as with measured environmental concentrations (MEC), to demonstrate their impact on the regional risk quotients. Finally, we briefly discuss the prevailing uncertainties and challenges of current ecotoxicity testing, especially outcomes of chronic and nonlethal effects.
摘要：
在全世界的水生环境中广泛检测到药物残留物，主要来自污水系统中的人类排泄物。目前,公开可用,药品的高质量环境风险评估(ERA)数据有限。然而,像SwedishFass这样的数据库提供了宝贵的资源，可帮助医疗保健专业人员和环境科学家识别重要关注的物质。在这次审查中,我们提供了用于人类使用的药品的监管ERA流程的简要概述。我们使用37种药物的子集探索其关键假设和不确定性。首先,我们比较了Fass数据库中报告的预测无效应浓度与上市许可持有人的一致性.第二,我们将根据欧洲和国家药物消费统计数据之间的销售数据以及测量的环境浓度（MEC）计算的预测环境浓度（PEC）进行比较，展示它们对区域风险商的影响。最后,我们简要讨论当前生态毒性测试的主要不确定性和挑战，尤其是慢性和非致死效应的结果。
