Pharmaceuticals in the environment
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Patient use, improper disposal of unused medicines, and discharges from pharmaceutical manufacturing can result in trace levels of active pharmaceutical ingredients (APIs) entering the environment. AstraZeneca recognises Pharmaceuticals in the Environment (PIE) as a material environmental risk linked to water quality and biodiversity, and manages this risk using a science‑based, lifecycle approach.
Our approach
We lead our industry in the management of PIE-related topics: we were the first company to publish discharge limit targets for drug production and formulation facilities that were externally verified, and were also the first company to publish environmental risk assessment (ERA) data on our website.
We are the only company with a published approach to ecopharmacovigilance (EPV), which is used to assess real-world environmental exposure and emerging scientific evidence. This enables the ongoing review of location-specific or future risks associated with population growth, ageing demographics, urbanisation and access to medicines.
We work in partnership with academic institutions to develop new tools and knowledge to help understand the environmental risk that pharmaceuticals pose and to support the next generation of environmental scientists. We are committed to progressing the science of PIE and continue to produce scientific publications in the field. These collaborations support the evolution of science-based regulation and strengthen our long-term environmental risk management.
Safe active pharmaceutical ingredient (API) Discharge Programme
Waste from the manufacture of medicines can be a local, intermittent issue that is within our control and therefore it is important we manage this. While there are currently no, or few, regional regulatory requirements, we run a ‘Safe API Discharge’ programme for both our production sites and those of our suppliers.
We are transparent about the methodology we follow and the discharge concentration targets for our APIs, and we support and follow the principles of the IAI technical guidance document on responsible manufacturing effluent management.
We assign two discharge concentrations for each API, one for long-term exposure, an Environmental Reference Concentration (ERC), and one for short-term exposure called a Maximum Tolerable Concentration (MTC). If a site identifies either of these reference concentrations to be over the limit, we conduct a thorough investigation and implement the necessary corrective actions.
EcoPharmacoVigilance Dashboard
As a result of patient use and manufacture, pharmaceuticals are found in the aquatic environment, typically in nanograms per litre concentrations. We conduct a robust environmental risk assessment for our products and report a programme of safe discharge from manufacturing facilities.
The EcoPharmacoVigilance dashboard provides transparent, ongoing disclosure of measured environmental concentrations to support informed dialogue with regulators, investors and other stakeholders.
As part of our ongoing EcoPharmacoVigilance, we also undertake a quarterly search of the published, peer-reviewed scientific literature for reports of detection of environmental residues of our APIs so that we can understand real world environmental risks.
These measured environmental concentrations (MECs) have been extracted and formatted for transparent visualiation in our EcoPharmacoVigilance dashboard.
