Active pharmaceutical ingredients (APIs) of medicines for human use can be released to the environment during the manufacturing process, following use by patients or when unused medicines are disposed of in an incorrect manner. As APIs are biologically active compounds, concerns have been raised about the potential effects of APIs in the environment on human and environmental health. Over the past 25+ years, a substantial amount of work has been done to determine the occurrence, fate, effects and resulting risks of APIs in the environment, and regulatory schemes have been developed requiring environmental risk assessments of all new APIs. However, for most APIs currently in use, only limited data are available on environmental risks, and for new APIs, the testing schemes may not always be optimal.
The aim of iPiE therefore is to develop frameworks that utilize information from toxicological studies, pharmacological mode of action and in silico models to support intelligence-based environmental testing of pharmaceuticals in development and to prioritise legacy pharmaceuticals (those authorized prior to the 2006 enactment of the European Medicines Agency requirements) for targeted environmental risk assessment and/or environmental (bio-) monitoring.
This aim will be delivered through a number of specific objectives:
- To review existing approaches for prioritization of APIs and their intelligent testing based on mode of action and to develop improved frameworks for such purposes.
- To establish a high quality database on the properties, environmental fate characteristics and ecotoxicity of APIs
- To develop methods for estimating external and internal exposure to APIs for different scenarios
- To develop methods and models for predicting ecotoxicological responses to APIs
- To validate the developed models, concepts and frameworks using targeted experiments
- To develop a software system to support intelligent testing and prioritization of APIs in the environment
- To develop guidance on how the software system and associated predictive tools can be used
- To engage with and exchange knowledge with stakeholder groups throughout the project
ECT is involved in this project as partner. In particular, ECT is represented in the executive team that is responsible for the day-to-day management of the project, leads work package 5, and contributes to other work packages. In WP 5, experimental work related to behaviour and effects of pharmaceuticals is conducted that aims to validate models and assessment framework developed in other work packages.