Pharmaceuticals in the environment
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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. We were also the first company to publish environmental risk assessment (ERA) data on our website and we are the only company with a published approach to ecopharmacovigilance (EPV). EPV ensures that we review emerging information that might change the way we assess and manage the environmental risks of our medicines. Read more about our specific approaches to managing PIE in the sections below. Management of PIE is embedded within AstraZeneca and is overseen through defined governance processes. Performance and progress are reported through AstraZeneca’s annual sustainability reporting, ensuring transparency for investors and other stakeholders.
Where APIs are detected, AstraZeneca uses its EcoPharmacoVigilance (EPV) programme to assess real‑world environmental exposure and emerging scientific evidence, enabling ongoing review of location‑specific or future risks associated with population growth, ageing demographics, urbanisation and access to medicines.
AstraZeneca works in partnership with academic thought leaders to develop new tools and knowledge to help understand the environmental risk that pharmaceuticals pose. We are also committed to supporting the next generation of environmental scientists. At any one time, we support around ten PhD students in collaboration with United Kingdom Research Innovation, who are conducting research on critical issues that underpin the protection of our natural environment. We are committed to progressing the science of PIE and continue to produce scientific publications in this field. These collaborations support the evolution of science‑based regulation and strengthen AstraZeneca’s long‑term environmental risk management.
Safe 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 we have established for our APIs, and we support and follow the principles of the IAI technical guidance document on responsible manufacturing effluent management in the implementation of these. 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 an exceedance of either of these reference concentrations, we conduct a thorough investigation and implement the necessary corrective actions. We set measurable targets with respect to API discharges, and report against these in our annual sustainability report. For each API, AstraZeneca establishes science‑based discharge thresholds for long‑term and short‑term exposure. Any exceedance triggers investigation and corrective action, and performance against discharge targets is reported annually.
EcoPharmacoVigilance Dashboard
As a result of patient use and manufacture, pharmaceuticals are found in the aquatic environment, typically in nanograms per litre concentrations. AstraZeneca conducts a robust environmental risk assessment for its products and reports 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 its ongoing EcoPharmacoVigilance AstraZeneca also undertakes a quarterly search of the published, peer-reviewed scientific literature for reports of detection of environmental residues of our active pharmaceutical ingredients (APIs) in order to understand real world environmental risks.
These measured environmental concentrations (MECs) have been extracted and formatted for transparent visualization in our EcoPharmacoVigilance dashboard.
