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.
In many cases, our APIs are not detected in the environment. When our APIs have been detected, in almost all cases these APIs have been shown via our EPV process to pose low or insignificant environmental risk. There can be some location-specific environmental risks for particular pharmaceuticals, especially in regions where there may be inadequate sewage treatment and high populations of people discharging waste into rivers with low dilution conditions. Our ongoing EPV monitors whether increases in the global population, an ageing population demographic, increased access to medicines in low- and middle-income countries, urbanisation and/or changes in disease epidemiology will change these risks in the future.
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.
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.
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 in addition to our Safe API Discharge programme for manufacturing facilities.
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. Of 40 APIs included in the search, reports of measured data have been found for 32 of those APIs. These measured environmental concentrations (MECs) have been extracted and formatted for transparent visualization. The EcoPharmacoVigilance Dashboard presents these MECs in a risk relationship relative to the Predicted No Effect Concentrations (PNECs) used for environmental assessment. Calculated RQs that are displayed as 0.0 denote risk quotients that are lower than 1x10-9.
This dashboard was last updated in October 2023 based on literature searches performed up to Q2 2023 and now has 46,931 data entries. The last update included first reports of one additional API.
The EcoPharmacoVigilance Dashboard was developed in association with Simomics Ltd. To get the best experience, we recommend using the latest version of Chrome, Edge, Safari or Firefox.
Our stories
Assessing environmental risks earlier in drug development
The Innovative Medicines Initiative (IMI) is a public-private partnership that works to improve health by speeding up the development of, and patient access to, innovative medicines.
Advocating for science-based policy
At the virtual Society of Environmental Toxicology and Chemistry (SETAC) Europe meeting in 2020, AstraZeneca was a strong advocate for science-based policy.