AstraZeneca opens up on pharmaceuticals in the environment (PIE)

By Chris Wheal

February 28, 2024

Only a small proportion of pharmaceuticals in the environment are from manufacturing

AstraZeneca has issued an update on its activities to contain and reduce pharmaceuticals in the environment (PIE).

While admitting concerns continue that levels of PIE will rise over the coming years, AZ lists its actions to reduce the impact of its drugs.

Dave Ennis, VP for environmental protection, is quoted saying: “We have a history and track record of leadership in this space, and we continue to invest in partnerships to progress science and regulation in the area, and to be transparent about our findings.”

The February 2024 statement begins: “Pharmaceuticals entering the environment is an unavoidable result of delivering life-changing medicines to patients. We recognise our most material water pollution risk as the active pharmaceutical ingredients (APIs) found in our products. APIs are biologically active molecules and may interact with and impact wildlife and biodiversity when in the environment.

“At AstraZeneca, our aim is to minimise the environmental impact of our products for more sustainable healthcare.”

Users and disposal the main cause

The majority of PIE can be traced to users, with manufacturers contributing the smallest amount. But AZ says: “As production is the part we can control, it is the area where AstraZeneca can make the most impact. 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.”

AZ says: “Trace amounts of pharmaceuticals have been detected in the environment for more than 20 years, and we recognise that the levels of PIE will likely rise, particularly in regions where there is an increased consumption of pharmaceuticals due to improved access to medicines and/or as a result of an ageing population.”

AZ insists research published in the past five years has shown that most drugs pose low risk but says “with an ever- changing climate, it is important we continue to understand the risk profiles of our medicines”.

Environmental risks

Problems are real, AZ admits. “A number of pharmaceuticals are now routinely detected in water bodies near where people live, and some can cause location-specific environmental risks, especially in regions where there may be inadequate sewage infrastructure, a high population density and rivers with low flow conditions.”

All companies check for Predicted No Effect Concentrations (PNECs). The PNEC of an API is the concentration below which we do not expect it to have any effect in the environment. AZ’s statement admits it has had issues but monitoring allows it to fix problems fast.

Cooperation for improvements

But the company, which claims to be a leader in the field, is involved in industry-wide bodies and international projects to cut PIE. These include:

• Contributing to the extended Environmental Risk Assessment (eERA) proposal aimed at strengthening the EU’s environmental risk assessment (ERA) process
• Leading the PREMIER project, which brings together 28 partners from the public and private sectors, who are working to contribute to a sustainable future by proactively managing the environmental impact of medicines
• Being a member of the Inter- association Initiative Task Force on PIE (IAI PIE TF), which was developed for the European pharmaceutical industry to address environmental policy and science issues relating to human pharmaceuticals.
• Being a member of the Pharmaceutical Supply Chain Initiative (PSCI)
• Working with the European Federation of Pharmaceutical Industry Association (EFPIA).

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