Assessment of potential risks of 11 pharmaceuticals for the environment : Using environmental information from public databases
Schatting van potentiële risico's voor het watermilieu van 11 geneesmiddelen : Gebruikmakend van openbaar beschikbare milieu-informatie
26 May 2012, PDF |
30 pages |
van der Aa NGFM, van Vlaardingen PLA, van Leeuwen LC, Post M
RIVM Report 601711003
The presence of pharmaceuticals and their degradation products in the water environment can be harmful for the ecosystem. For 22 pharmaceuticals some public government databases were searched for information on these harmful effects (environmental endpoint data) for 22 selected pharmaceuticals. These pharmaceuticals were selected because they are frequently consumed in the Netherlands or identified as a problem for the production of drinking water. Their degradation products are excreted in urine and subsequently can reach the water system. Based on environmental endpoint data Predicted No Effect Concentrations (PNECs) can be derived: below this concentration harmful effects are not expected. Combined with Predicted Environmental Concentrations (PECs) can PEC/PNEC ratio's help identify possible risks for the water ecosystem at an early stage.
One out of three databases contains information on environmental endpoint data:
Neither the Dutch "Geneesmiddeleninformatiebank" nor the European Public Assessment Reports (EPARs) publised on the European Medicines Agency (EMA) website currently contain the requested information. The Swedish Environmental Classification and Information System (SECIS) for pharmaceuticals does contain this information for 15 pharmaceuticals. For 13 pharmaceuticals this information was sufficient to derive preliminary PNECs (Predicted No Effect Concentrations).
Possible risks for two out of thirteen evaluated pharmaceuticals:
Together with Predicted Environmental Concentrations (PECs) based on yearly consumption of the pharmaceutical in the Netherlands, preliminary PEC/PNEC ratios could be calculated. For two out of the 13 evaluated pharmaceuticals (the antibiotic amoxicillin and the hormone ethinylestradiol) these ratios were above 1. This means that risks for the freshwater ecosystem might be expected from the use of these individual substances as human medicines. To evaluate if these risks actually occur, an extended environmental fate and effect analysis is required.