Amsterdam Institute for Life and Environment, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Amsterdam Institute for Global Health and Development, University of Amsterdam, Amsterdam, The Netherlands.
Environ Toxicol Chem. 2024 Mar;43(3):611-622. doi: 10.1002/etc.5535. Epub 2023 Jan 16.
How can data on the occurrence of pharmaceuticals and personal care products (PPCPs) in the environment and the quality of ecosystems exposed to PPCPs be used to determine whether current regulatory risk assessment schemes are effective? This is one of 20 "big questions" concerning PPCPs in the environment posed in a landmark review paper in 2012. Ten years later, we review the developments around this question, focusing on the first P in PPCPs, that is, pharmaceuticals, or more specifically the active ingredients included in them (active pharmaceutical ingredients, APIs). We illustrate how extensive data on both the occurrence of APIs and the ecotoxicological sensitivity of aquatic species to them can be used in a retrospective risk assessment. In the Netherlands, current regulatory risk assessment schemes offer insufficient protection against direct ecotoxicological effects from APIs: the toxic pressure exerted by the 39 APIs included in our study exceeds the policy-related protective threshold of 0.05 (the "95%-protection level") in at least 13% of sampled surface waters. In general, anti-inflammatory and antirheumatic products (e.g., diclofenac, ibuprofen) contributed most to the overall toxic pressure, followed by sex hormones and modulators of the genital system (e.g., ethinylestradiol) and psychoanaleptics (e.g., caffeine). We formulated three open questions for future research. The first relates to improving the availability and accessibility of good-quality ecotoxicity data on pharmaceuticals for the global scientific, regulatory, and general public. The second relates to the adaptation of regulatory risk assessment frameworks for developing regions of the world. The third relates to the integration of effect-based and ecological approaches into regulatory risk assessment practice. Environ Toxicol Chem 2024;43:611-622. © 2022 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.
环境中药物和个人护理产品 (PPCPs) 的出现数据以及暴露于 PPCPs 的生态系统的质量如何用于确定当前的监管风险评估方案是否有效？这是 2012 年一篇具有里程碑意义的评论文章中提出的关于环境中 PPCPs 的 20 个“大问题”之一。十年后，我们回顾了围绕这个问题的发展，重点关注 PPCPs 中的第一个 P，即药物，或者更具体地说是其中包含的活性成分（活性药物成分，APIs）。我们举例说明了如何在回顾性风险评估中广泛使用 API 的出现数据和水生物种对它们的生态毒理学敏感性数据。在荷兰，当前的监管风险评估方案对 API 的直接生态毒理学效应提供的保护不足：我们研究中包含的 39 种 API 施加的毒性压力至少在 13%的采样地表水超过了与政策相关的保护阈值 0.05（“95%-保护水平”）。一般来说，抗炎和抗风湿产品（如双氯芬酸、布洛芬）对总体毒性压力的贡献最大，其次是性激素和生殖系统调节剂（如炔雌醇）和精神兴奋剂（如咖啡因）。我们为未来的研究提出了三个开放性问题。第一个问题涉及改善全球科学界、监管机构和公众对药物的高质量生态毒性数据的可用性和可及性。第二个问题涉及为世界上发展中地区的监管风险评估框架的调整。第三个问题涉及将基于效应的和生态的方法整合到监管风险评估实践中。环境毒理学与化学 2024；43：611-622。© 2022 作者。环境毒理学与化学由 Wiley 期刊出版公司代表 SETAC 出版。
