PREMIER partners publish new scientific paper: Prioritisation of data-poor pharmaceuticals for empirical testing and environmental risk assessment

Over 3,500 active pharmaceutical ingredients (APIs) are used globally in human and veterinary medicine. After use, many of these substances reach rivers and lakes, potentially harming aquatic life. However, assessing the environmental risk of every API is currently unfeasible due to limited data. To address this, we conducted a prioritisation study to identify which APIs should be tested first. We evaluated over 1,000 APIs used in Europe by estimating their potential risk to freshwater ecosystems. Risk was calculated by comparing predicted or measured environmental concentrations (PECs or MECs) with predicted no effect concentrations (PNECs). Since experimental data are limited, we combined available measurements with computer-based (in silico) estimates to generate several risk-based rankings.

Our analysis confirmed that PECs estimated using default parameters from the European Medicines Agency are often – but not always – conservative. Among the three tested species groups, fish were the most sensitive for most APIs. Additionally, while in silico tools may underestimate ecotoxicity, they remain valuable for supporting prioritisation approaches like ours. By integrating multiple risk rankings, we finally identified 15 APIs to prioritise for further ecotoxicity testing and exposure assessment.

Please note that in the near future, the prioritisation exercise presented in this study will be refined using additional predictive tools and broader pharmaceutical coverage, including antibiotics and endocrine active substances.

See the article here.