Prioritisation and Risk Evaluation of Medicines in the EnviRonment

There are nearly 2 000 active pharmaceutical ingredients (APIs) in use, but little is known about the risks they pose to the environment. As a result, there is an urgent need for science-based methods that identify environmental threats earlier in the drug development process. The EU-funded PREMIER project proposes an information and assessment system based on minimum testing that describes the environmental risk of APIs, including relevant human metabolites and environmental transformation products. The system will deliver tailored assessment, identify potential environmental damage and make existing environmental data more accessible for all stakeholders. The project will combine world-leading research on the environmental threats represented by APIs with the principles of co-design and smart knowledge-based IT. There are around 1900 active pharmaceutical ingredients (APIs) in use, yet the environmental risks of only a small proportion of these has been assessed. This calls for pragmatic science-based approaches for prioritising existing APIs in terms of their environmental risk. Such approaches could also be used pro-actively, i.e. to identify environmental concerns earlier in the drug development process, thereby contributing to a more sustainable future. The overall aim of PREMIER is to deliver an API information and assessment system for characterising the potential environmental risks of APIs, including relevant human metabolites and environmental transformation products, based on minimal testing. This system will be designed to screen and prioritise legacy APIs for tailored environmental assessment; identify potential environmental hazards associated with APIs in development; and to make the available environmental data more accessible for all stakeholders. The system will be optimized and validated using case studies on approximately 25 APIs. PREMIER will realize its aim by combining world-leading research on the environmental risks of APIs with
the principles of co-design and smart knowledge-based IT. Through this combination, we want to be more than a conventional research project. We want to ensure that the results of our ground-breaking research “work” address all the societal concerns about the potential risks posed by the presence of pharmaceuticals in the environment.