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Pharmaceuticals in the environment

When patients use pharmaceuticals, some of the active ingredient may not be completely metabolised and will generally be excreted. Wastewater treatment plants remove most pharmaceutical residues in the environment, but small concentrations do end up in rivers or the sea. In areas without wastewater treatment, higher concentrations are released to the environment.

In 2004, following consultation with external stakeholders, we developed a draft position statement on pharmaceuticals in the environment. This will be completed in 2005.

Internally, we have developed business processes to ensure that we carry out appropriate environmental tests as and when we should. Since environmental risk assessments (ERAs) are part of the new drug approval process in the EU and US, we work with various regulatory agencies to ensure that the potential environmental impacts of pharmaceuticals are understood and minimised. 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, a geographically explicit model based on hydrology and population patterns. See more on our approach to pharmaceuticals in the environment.

In 2004, we initiated more comprehensive environmental risk assessments using the PhATE™ model for about 40 active pharmaceutical ingredients (APIs), including paroxetine (the active ingredient in Paxil/Seroxat). These assessments will be published on our website. 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 our website at www.msds-gsk.com.

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

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