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European Biopharmaceutical Review

Environmental Exposure

Brigitte van Noorloos at NOTOX examines the impact of pharmaceuticals on the environment, and the step-by-step approach that offers the industry clear guidance

The medicines that we take have gone through at least 10 years of testing so that their safety for humans can be guaranteed. However, we are not the only ones that may be exposed to these drugs. Human drugs may also affect animals, plants and bacteria as they can enter the environment via human excreta or by the disposal of expired medicines via the sewer. This has been recognised by the EU and, from December 2006, it is not only the efficacy of pharmaceuticals and their side effects that need to be evaluated, but also the environmental impact of the active ingredients. This article provides an outline of the EUEMEA guideline’s step-by-step approach.

BACKGROUND

In the last 15 to 20 years there have been several reports of pharmaceuticals affecting the environment: human and veterinary drugs have been detected in river water and even drinking water (1,2). Although reported levels are very low, some negative effects were observed, a noteworthy example being hormone disruption in fish due to the presence of estrogens in the environment.

In the case of use, patients will usually excrete a drug or its metabolites, which then pass to a sewage treatment plant. There, they may be partially degraded, they may be adsorbed to the sludge, or they may remain in the effluent. After processing at the sewage treatment plant, the sludge is usually incinerated, but it may also be spread on the land, and then leach into the soil and eventually into the groundwater. In terms of disposal, depending on the route (drain, household or industrial waste), pharmaceuticals may enter the groundwater and surface water via a sewage treatment plant or by leaching from a landfill site.

Although pharmaceuticals and their metabolites in excreta will be diluted before entering the sewage treatment plant, and even though leaching from a landfill site may be limited, it should be kept in mind that drugs are usually relatively stable – after all, they were developed to remain intact in the human body, at least for a certain period. Furthermore, as they were developed with the objective to cause a physiological effect in humans, other organisms may be sensitive to them as well.


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Brigitte van Noorloos graduated with an MSc in Chemistry from the University of Nijmegen, the Netherlands. Since 2000, she has supervised environmental fate and metabolism studies at NOTOX in ‘s-Hertogenbosch, the Netherlands. Initially, the work mainly concerned agrochemicals and industrial chemicals, but now pharmaceuticals have also become a major area of environmental testing. Brigitte was also involved in dossier preparation of high production volume chemicals and the risk evaluation of agrochemicals for the Dutch Board for the Authorisation of Pesticides (CTB).
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Brigitte van Noorloos
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