Environmental Risk Assessment for Human Pharmaceuticals: The Current State of International Regulations

Abstract

Pharmaceuticals have become chemicals of emerging concern to the public because of their potential to reach drinking water. Patient use of medicines is the principal pathway by which pharmaceuticals (prescription and over the counter) find their way into the aquatic environment. Typically, a fraction of the medicines taken by patients is excreted and enters waterways. To a lesser extent, pharmaceuticals can enter the environment through improper disposal of medicines and from manufacturing discharges. For over a decade, trace concentrations of pharmaceuticals have been detected in the aquatic environment in the U.S. and other countries. The issue has gained increasing attention, in scientific literature and the media, with governments, regulators and with other stakeholders (e.g., socially responsible investors). At the heart of the issue is whether existing controls (regulatory and other) of pharmaceuticals are protective of human health and the environment. There are no reported adverse human health effects attributed to drugs in the aquatic environment. Data currently fail to show any connection between the concentration of pharmaceuticals detected in the aquatic environment and acute environmental effects with the notable exception of some hormones in certain circumstances. Some studies suggest that in specific situations, chronic environmental exposure of certain species to select classes of pharmaceuticals (e.g., hormones) may be linked with environmental effects.