Our new EcoPharmacoVigilance (EPV) Risk Visualisation Dashboard demonstrates our ongoing commitment to environmental protection and transparency, two pillars of our sustainability strategy. This innovative dashboard, developed and maintained by Simomics, an ethics-led software technology enterprise spun out from the University of York, shows the relative risks of pharmaceuticals that reach the environment through patient use, which helps to manage any associated risk and ensure the environmental safety of our life-changing medicines.
As an unintended but inevitable result of patients using life-changing medicines, traces of active pharmaceutical ingredients (APIs) can be detected in the environment. A few thousand APIs have been approved for use in medicinal products, but knowledge about their potential effect on nature as a result of their patient use post-approval is still quite limited, as is the information available to the wider industry, regulatory, academic and public stakeholder communities. In Europe and the United States, an environmental risk assessment (ERA) is conducted at the time of the marketing application for medicinal products that are in scope. This ERA generates a single risk quotient for surface waters based on a predicted environmental concentration and a no effect or safe concentrations. Our EPV dashboard enables us to look at the real-world environmental risk resulting from patient use by comparing measured environmental concentrations with these no effect or safe concentration. In some cases, we can have >1000 measured environmental concentrations for an API and that allows us to do a more sophisticated semi-probabilistic ERA. When our APIs have been detected, in almost all cases these pose low or insignificant environmental risk, and in many cases our APIs are not present at all in the environmental samples that have been analysed by environmental chemists. However, we are committed to ensuring the environmental safety of our products and managing any potential impact they have.
This is the first time that the EPV Risk Visualisation Dashboard has been used to share the data of an individual pharmaceutical company. This builds on our work with the Innovative Medicines Initiative (IMI) a public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to develop tools to identify the potential environmental risks of APIs and make this data more visible and accessible to all stakeholders through a project called PREMIER.
As part of our pioneering approach to EPV, the Risk Visualisation Dashboard uses an interactive map which shows the locations and measured environmental concentrations (MECs) of these APIs in the environment, and the associated risk. To populate it, Simomics uses data gathered through quarterly searches of all published, peer-reviewed, scientific literature relating to reports of search and detection of our active pharmaceutical ingredients (APIs) in the environment. The information displayed can be filtered by substance, environmental compartment, or location. Citations of the original scientific literature can be found for each data point reflected on the map by selecting a point of interest.
Improved, more transparent, use of data on the environmental risk posed by patient use of pharmaceuticals is an important step towards understanding the real-world risks that are posed and developing informed strategies to reduce the impact that moderate or high-risk APIs pose on the aquatic environment and wider ecosystems.
Our commitment to transparency around the environmental risks associated with APIs
To ensure the environmental safety of our life-changing medicines, we are committed to understanding and preventing adverse effects of pharmaceuticals in the environment.
Over the past decade we have collaborated with leading academic institutions around the world, and part of our work with IMI PREMIER is responding to the major challenge of the lack of environmental data for pharmaceuticals in the public domain.
We were the first company to publish ERA data on our website and we conduct robust environmental risk assessment for our products. We will continue to make it a priority to effectively manage the risks associated with Pharmaceuticals in the Environment (PIE), including through initiatives such as the EPV dashboard, building on our longstanding commitments to ensure we are transparent about how we operate. Learn more in our pharmaceuticals in the environment video.