At AstraZeneca we are proactively addressing the problem of pharmaceuticals entering the environment as a result of our manufacturing discharges (Nature 476, 265; 2011).
Using ecotoxicity data and our knowledge of environmental fate and the local environment, we have identified long- and short-term concentrations of active pharmaceutical ingredients that we refer to as Environmental Reference Concentrations (ERCs) and Maximum Tolerable Concentrations (MTCs), respectively. These should not be exceeded in the aquatic environments that receive effluent from our manufacturing sites.
This approach is based on established environmental quality standards used in national and international legislation. Under this voluntary initiative, we have so far established ERCs and MTCs for 30 of our active pharmaceutical ingredients to protect the freshwater environment (algae, invertebrates and fish), top predators (fish-eating mammals such as otters), the marine environment (for coastal discharges) and humans. Other research-based pharmaceutical industries also have voluntary initiatives to control their discharges.
We have 'ecopharmacovigilance' procedures in place to ensure that our ERCs continue to take into account all relevant data and current scientific understanding of the fate and effects of pharmaceuticals in the environment. For example, if a new, lower, no-effect concentration is reported in the peer-reviewed literature and is scientifically robust, we revise our ERCs and environmental risk assessments accordingly.
Last year, we started a programme to monitor our own emissions against ERC and MTC values for our worldwide sites that could discharge waste water containing active pharmaceutical ingredients during peak production. We are now starting to share the ERC approach with our third-party manufacturers, with a view to including them in the programme.
The authors are employed by AstraZeneca UK and own shares in AstraZeneca.
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Snape, J., Lewis, C. & Murray-Smith, R. Drug firm monitors waste water. Nature 477, 33 (2011). https://doi.org/10.1038/477033c