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Pharmaceuticals in the environment

Drugs work through active pharmaceutical ingredients that are absorbed in the patient’s body. These materials – including anything that is not absorbed - are eventually excreted through the body’s normal mechanisms and enter the sewage system. Wastewater treatment plants remove most pharmaceutical residues, but small concentrations do end up in rivers or in the sea. In areas without wastewater treatment, higher concentrations enter the environment.

Pharmaceuticals have been detected in surface, ground and drinking waters in the US and Europe. This has raised concerns about potential impacts on people, animals and the environment, eg: contributing to antibiotic resistance; feminisation by oestrogens; the effects of highly potent drugs on environmental organisms; the presence of anti-depressants in drinking water; the effects on wildlife of veterinary drugs such as pain killers. Regulators are now acting on these concerns. For example, the Swedish authorities now require additional information to classify pharmaceuticals by environmental impacts, the European Union is proposing more extensive environmental testing for product registrations, while others are investigating mitigation measures such as take-back schemes, water treatment upgrades, and labelling revisions.

GSK has developed business processes to ensure that we carry out appropriate environmental tests. Environmental risk assessments are part of the approval process for new drugs in the EU and US, so we provide regulatory agencies with assessments to evaluate and allow for mitigation of any potential environmental impacts.

We also work with other pharmaceutical companies, universities and research groups to develop the science and methodologies to assess the environmental risks of pharmaceuticals in the environment and increase understanding of such risks. For example, in the US, GSK has been involved with the Pharmaceutical Research and Manufacturers of America (PhRMA) in developing the PhATE (Pharmaceutical Assessment and Transport Evaluation) model based on specific local hydrology and population patterns. See more on our approach to pharmaceuticals in the environment.

Action in 2005
We finalised the position paper on pharmaceuticals in the environment which was developed in 2004, after extensive internal consultation. The paper was approved in December 2005.

We engaged with the US Interagency Task Force on Pharmaceuticals in the Environment, and with the UK Environment Agency through PhRMA and the Association of the British Pharmaceutical Industry respectively. We are interacting with other governmental groups working in this area, such as the US Environmental Protection Agency and the US Geological Survey and are establishing relationships with groups working on this issue in Europe.

GSK scientists who had been part of the team of experts at an international scientific workshop in 2003 on human pharmaceuticals in the environment co-authored a number of chapters in a book: Human Pharmaceuticals: Assessing the impacts on aquatic ecosystems, published in 2005. This work provides a roadmap for industry, government and academia for research in this area.

We have worked with PhRMA to develop a database of scientific literature on the impacts of pharmaceuticals on aquatic life. We have also collaborated to prepare detailed human health and environmental risk assessments on several frequently-detected pharmaceuticals (carbamazepine, aspirin, paracetamol, ibuprofen and naproxen). This work is part of on-going PhRMA research to improve understanding and provide data needed to prioritize further investigation.

We continued comprehensive environmental risk assessments using the PhATE™ model for the US and the GREAT-ER model for Europe for about 35 active pharmaceutical ingredients. We developed Allowable Daily Intake levels for human consumption through drinking water and fish consumption, as well as No-Effects Levels for aquatic organisms. We can make quantitative risk assessments by comparing these with predicted environmental concentrations.

These assessments will be published on our website and in the peer-reviewed scientific literature. The underlying environmental fate and effects test data for pharmaceutically active components of GSK-marketed products are now being embedded in Safety Data Sheets (SDS). These are available on the MSDS website.

The risk assessments carried out to date indicate that our products do not appear to pose an appreciable risk for humans or the environment based on current methods for ascertaining effect levels. But we continue to monitor the latest scientific studies and findings to improve our risk assessments in this area.

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