Human pharmaceuticals are routinely detected in wastewater, surface water, and aquatic organisms. Significant advances in instrumentation, analytical techniques, and methodologies have enhanced the ability to detect pharmaceuticals in the environment at lower and lower concentrations. Following manufacturing and patient use, pharmaceutical residues, including active ingredients, human metabolite,s and/or transformation products present in domestic and industrial wastewater treatment effluents are released into the aquatic environment.

The presence of pharmaceuticals in the environment (PIE) and the need to understand associated risks has become the focus of numerous research initiatives among industry, academia and governmental agencies worldwide. Regulatory requirements to provide an environmental risk assessment (ERA) associated with patient use for drug registration have been in place within the US and EU for 14+ years, with legislation in other geographical regions expected in the coming years.

The focus of this presentation is to provide a greater understanding of the potential environmental risk of pharmaceuticals following patient use. A review of the ERA regulatory requirements for drug approval, the knowledge acquired over the last 14+ years, and key areas of ongoing research supported by industry, academia, and governmental agencies worldwide will be discussed.