May 10, 2021 by Dean Leverett

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I co-chaired a live virtual discussion on Pharmaceuticals in the Environment in the final session block of SETAC Europe 2021.

The discussion was split into three blocks, each covering a separate, but related, themed question. Each block included brief summaries of key ‘on demand’ presentations from the session (4.14) around the theme and then an open discussion.

1. Are we making adequate progress towards improving the Environmental Risk Assessment of pharmaceuticals? Focusing on regulatory ERA for human and veterinary pharmaceuticals, key presentations in this area comprised those covering development of ERA guidelines (e.g. EMA, VICH), and strategies for improving the information utilised within the risk assessments (exposure and hazard) – such as using pharmaceutical sales data to support PEC derivation, and the tailoring of risk assessments for antibiotics and endocrine-active substances.
2. When considering the risk of pharmaceuticals in the environment, do we need to consider and address this in the context of regional challenges? In this block, the environmental risks of pharmaceuticals in low and middle income countries (LMIC) was discussed. Key presentations covered the monitoring and risk assessment of a wide-range of human pharmaceuticals (and some illegal narcotics) in the Amazon, and a comparison of pharmaceutical exposure levels in Zambia and Kenya with a high income country (Finland). Particular problems in LMICs are clearly the low levels of wastewater treatment, even in urban areas with dense populations, and the need to account for the role of suspended particulate matter when assessing the environmental exposures of pharmaceuticals, as well as the increased risk of antimicrobial resistance.
3. Should we integrate research findings on non-standard end-points (e.g. behavioural responses) into policy frameworks and threshold guidance? Here, there is an ongoing debate on how we link and take account of research highlighting sub-organism and individual-level responses to pharmaceuticals in aquatic organisms and novel, non-standard test designs and endpoints into regulatory risk assessment frameworks. Key presentations covered uptake, metabolism and effects of diclofenac in freshwater shrimps, the combined effects of increased temperature and pharmaceutical exposure in transgenic zebrafish, and effects on the metabolome of freshwater mussels. This is always a difficult subject to give enough justice to in a short discussion. However, the primary issues remain the validity, reproducibility, reliability assessment and establishment of clear links to population sustainability, while acknowledging that the available standardised tests are unable to fully resolve the myriad of different types of effect that may occur on exposure to bio-active substances.