Current uncertainties and challenges of publicly available pharmaceutical environmental risk assessment data
2024
Ahkola, Heidi | Äystö, Lauri | Sikanen, T. | Riikonen, S. | Pihlaja, T. | Kauppi, Sari | Suomen ympäristökeskus | The Finnish Environment Institute | 0000-0002-3329-3749 | 0000-0001-5457-6580 | 0000-0001-7641-200X
Highlights • Publicly available environmental risk assessment data for pharmaceuticals is limited. • Environmental hazard information is mainly based on standardized ecotoxicity tests. • Risk assessment of chronic effects outcomes is limited and challenging. • Nonstandardized ecotoxicity assays could inform of nonstandard modes of action. • Local environmental risks are largely impacted by drug consumption volumes. 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.
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