Pharmaceuticals in the environment

Understanding the effects of our medicines on the natural world is a long-standing commitment for AstraZeneca.

We want to identify any potential adverse effects on the environment that our medicines might have so that we can responsibly balance these against the benefits that these medicines bring for patients. As part of the development process, each of our medicines undergoes a thorough environmental risk assessment before submission for marketing.

In recent years, an increasing amount of pharmaceutical residues have been detected in the environment, reflecting the advances in analytical techniques. We understand, and take seriously, the concerns that this has raised. Much of the published work on Pharmaceuticals in the Environment (PIE) concerns the detection of trace levels of pharmaceuticals in the environment that humans and wildlife might be exposed to. However, little of the work addresses the issue of potential risks or exposure effects associated with the pharmaceuticals. One focus of our research has been to bridge this gap.

Whilst improving all the time, the understanding of potential long-term effects, for example to aquatic life, needs further research.

Excretion from patients is recognised as the major source of pharmaceuticals in the environment, but inappropriate disposal of unused medicines is also a factor to consider. We work with national and local authorities to make appropriate disposal options and guidance available and to discourage disposal to the drain or directly to sewage systems. This includes support of approved, voluntary take back programmes where these are available.

Safe discharges

Whilst the majority of pharmaceuticals in the environment result from patient use, they may also enter the environment via manufacturing discharges. To ensure our manufacturing discharges are safe, we have developed the concept of Environmental Reference Concentrations (ERCs) and Maximum Tolerable Concentrations (MTCs), which should not be exceeded in the aquatic environment receiving our effluents.

The ERC represents the average concentration of an active pharmaceutical ingredient (API) in the receiving surface water, which would be unlikely to result in any adverse effects. We have also defined MTCs to control short term peak emissions associated with batch-wise production and cleaning activities. Our approach is based on established environmental quality standard concepts used in national and international legislation, together with published methodologies to protect the aquatic environment (algae, invertebrates and fish), top predators (fish-eating mammals such as otters) and humans. To date we have established ERCs and MTCs for 36 of our APIs.

Since 2010 we have been working to ensure that all of our worldwide manufacturing sites meet our ERC criteria.  We have also shared ERCs and MTCs with our key outsourced manufacturing partners, enabling them to risk assess and manage any emissions of the APIs they manufacture or formulate on our behalf, and us to better understand and manage the global footprint associated with our manufacturing activities. This work will continue throughout 2013 (see also ‘working with our suppliers’).

In line with our commitment to data transparency, we have also recently published a paper describing our methodology for deriving ERCs with the intention of furthering scientific debate on the issue of Pharmaceuticals in the Environment and giving others the opportunity to benefit from the approach we have developed.

Download (PDF)

We conduct environmental risk assessments for all our new, and many of our established products in accordance with applicable regulations. Going beyond the regulatory requirements, we have also reviewed the environmental risk assessments for many of our older established products and, where appropriate, have undertaken voluntary testing to refine the assessments.

We have also started to work towards a more ‘intelligent approach’ when it comes to Environmental Risk Assessment of our APIs. This means we are keen on improving the scientific aspect of the testing, to make sure the tests we undertake, and the principles we apply give the best possible answer to the question we are trying to answer. This includes testing of the most environmentally relevant form of the pharmaceutical, as well as the presumed most sensitive life stage of an organism, based on knowledge about the compound (see Dedicated Research).

Transparency

Our stakeholders, including patients, healthcare professionals and medical authorities, are increasingly interested in a medicine's environmental profile.

In line with AstraZeneca’s overall commitment to transparency and open communication, we make environmental risk assessment (ERA) data for our existing products publicly available via the Swedish Prescribing Guide website, using the voluntary disclosure system introduced by LIF, the research-based pharmaceutical industry association in Sweden.

We are now also publishing ERA data in a dedicated section within this website. This work is ongoing and we will continue to populate the section as more information becomes available.

Access ERA data

Our scientists are focused in particular on improving our understanding of the potential environmental exposure pathways and long-term effects of pharmaceuticals in the environment (PIE).

Located mainly at our Environmental Laboratory in Brixham, UK, we have a team of scientists dedicated to advancing PIE related research.

The levels of residues detected in the environment, associated with products in use, are generally extremely low and are unlikely to pose a risk to human health. For example, the amounts detected in drinking water are normally so low that to ingest one single patient dose, someone would have to drink more water than is possible in a lifetime. However, whilst improving all the time, understanding of the potential for exposure and long-term effects in the environment, for example to aquatic life, requires further research.

Work at our Brixham Environmental Laboratory is focussed on supporting the delivery of specific aspects of our SHE Strategy for our Product Environmental Improvement. Other aspects of our research work include:

•  Understanding and improving the environmental exposure and persistence assessments of pharmaceutical residues in the wider environment. We have current research projects determining whether the exposure assessments for Europe and North America are relevant for emerging markets where the infrastructure for waste treatment and water management practices could result in different patterns of exposure and possble impacts or risk. Exposure scenarios being investigated include terrestrial exposure via irrigation waters and the application of sludge or biosolids to land. This knowledge enhances our ability to predict concentrations in the environment and improves our understanding of the potential exposure of wildlife to pharmaceutical residues.
• Maximising the use of the large amount of pre-clinical data that is routinely produced as part of the pharmaceutical development process in order to assess the potential impact of drugs in the environment. Improved knowledge in this area will help ensure that environmental testing is focused on the most relevant test species and effect endpoints, as well as the environmentally relevant form of the pharmaceutical. In the longer term, we hope this ‘intelligent approach’ will lead to improved methods for predicting ecotoxicity and a reduction in the amount of animal testing required to support our environmental risk assessments.
• Understanding the development, regulation and dynamics of antimicrobial resistance in the natural environment as a result of environmental exposure to anti-infective drugs (e.g. antibiotics).

Engagement and communication

We actively engage and partner with other pharmaceutical companies, non-governmental organisations, scientists, regulators, patients, and prescribers to share scientific knowledge and experience to manage issues on this topic responsibly.

As part of this engagement, we continue to share our research by regularly publishing scientific papers in peer-reviewed journals and presenting at relevant learned societies.

We actively engage and partner with other pharmaceutical companies, non-governmental organisations, scientists, regulators, patients, and prescribers to share scientific knowledge and experience to manage issues on this topic responsibly.

As part of this, we continue to share our research by regularly publishing scientific papers in peer-reviewed journals. Some of our work is shown in the bibliography below.