The active ingredients in medicines (known as the active pharmaceutical ingredient, or API) can be released into the environment in a variety of ways. The most common route is via the sewage system, when patients excrete them. APIs can also escape into the environment when people dispose of medicines incorrectly, and during the manufacturing process. APIs are, by definition, biologically active, and although their concentration in the environment is generally extremely low, there are concerns about the effect of these chemicals on wildlife and ecosystems in general.
Since 2006, new medicines have had to undergo an environmental risk assessment before they are approved for use. However, current testing strategies need to be optimised to accurately predict harmful impacts on wildlife.
Furthermore, there are over 3 000 APIs that were already in use before the new rules came into force, and just a small number of these have been subjected to environmental impact testing. As testing all of these will be a mammoth task, guidance is needed to help identify which of these ‘legacy’ APIs are most likely to pose a risk to the environment and so should be prioritised for testing.
New, better methodologies for assessing environmental risks
The goal of the iPiE project is to develop frameworks to support the environmental testing of new pharmaceuticals and to help prioritise testing of legacy APIs. The frameworks will draw on information such as existing data on the environmental impact of APIs, toxicological studies, computer models, and studies of how medicines work.
Part of the project focuses on identifying existing methods for carrying out pharmaceutical environmental risk assessments. The project is also compiling a database that will include information on both APIs and test organisms. Another priority for the project is the development of new models for estimating exposure to APIs; this will take account of questions such as how much of an ingredient gets into the environment, how fast it is broken down, and the extent to which is accumulates in different parts of the environment. These methods will feed into the development of an exposure assessment tool that can be used to screen APIs under development and prioritise which existing APIs should undergo enhanced testing. In addition, the project plans to develop methods to predict the effects of APIs on different organisms in both terrestrial and aquatic environments. All models developed by the project will be validated experimentally.
User-friendly software and guidance
An important component of the project involves integrating the databases and methods developed into a user-friendly iPiE software system. Researchers will be able to carry out both simple searches and more advanced analyses based on scientific hypotheses. Accompanying guidance will demonstrate how the software can be used to both screen new APIs and prioritise testing of existing APIs.
Building on the work of other IMI projects
The iPiE project will draw heavily on the work of two existing IMI projects: eTOX and Open PHACTS. The iPiE database will be modelled on the eTOX database, which contains detailed information on the toxicity to humans of many existing APIs and so includes some fields required for the iPiE database. Another part of the iPiE project entails delving into publicly-available information, and for this iPiE will use the expertise of Open PHACTS, which specialises in this area.
A lasting impact
The iPiE project will make it easier for researchers to evaluate the potential impacts of new medicines in the earlier stages of development. It will also facilitate the identification of medicines that have never undergone environmental assessment yet could pose a serious risk to wildlife and the environment. Ultimately, by ensuring that APIs are developed and used in an environmentally sustainable way, the project will contribute to the health of the natural environment.