Pharmaceuticals in the environment
What is Pharmaceuticals in the environment at AstraZeneca?
Patient excretion, improper disposal of unused medicines and discharges from drug production result in the release of APIs into the environment. Potential impacts include effects in aquatic life from low-level and long-term exposure.
We are committed to the health and safety of the planet and people. We must understand and manage PIE to ensure that our medicines cause no negative impacts on the environment.
We lead our industry in the management of PIE related concerns. We are the only company with published targets describing safe discharge limits for drug production and formulation facilities that are externally verified. We were 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). EPV ensures that we follow the science and review emerging information that might change the way we assess and manage the environmental risks of our medicines.
See the graphic below that explores our milestones in PIE.
Our targets and progress
Stakeholder engagement in Kenya
In partnership with the University of Cambridge Institute for Sustainability Leadership, we convened stakeholders in Nairobi, Kenya to discuss PIE in the context of developing economies. Participants included government and inter-governmental agencies, non-governmental organisations, academia and industry with responsibilities for the management of healthcare and environmental resources. These discussions focused on actions needed to manage the environmental risks posed from the increased use of pharmaceuticals in low- and middle-income countries, especially considering that access to healthcare is increasing.
In many cases, adequate environmental infrastructure and regulation is not in place to manage some of the environmental risks that patient access poses. The aim of the workshop was to create a common vision, shared goals and an action plan to help ensure that access to medicines is managed in an environmentally sustainable manner. Access to healthcare, together with environmental protection and ensuring the environmental safety of our products, are interconnected components of our sustainability strategy and they cannot be considered in isolation.
Innovative Medicines Initiative (IMI) on PIE
The IMI is a public-private partnership between the European Commission and the innovationbased pharmaceutical industry (Efpia). In June 2019, the 5-year IMI Intelligent Assessment of PIE (iPiE) project concluded. Notable achievements that AstraZeneca contributed towards include:
- A high quality database on APIs (iPiESUM), including mainly industry sponsored studies for environmental fate, effects and behaviour of APIs, which had not been publicly accessible previously
- A review of the consumption based environmental risks for more than 120 APIs across Europe highlighting that even with worst-case exposure assessments less than 5% of drugs posed an environmental risk. The review highlighted significant data gaps for some modes of action
- A review of prioritisation approaches used to assess the hazard and risk of pharmaceuticals
1. Scope is 47 APIs for which data is available to calculate safe API discharge limits and based on 2018 manufacture.
2. At one AZ supply site there was a single measured API concentration that exceeded our API discharge limits. This followed a change implemented to reduce emissions; subsequently, further process improvements and monitoring were implemented, demonstrating emissions are now consistently below the safe API discharge limits.