Both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) require the submission of an environmental risk assessment (ERA) with an application for a marketing license for a new pharmaceutical product. This ERA is based on a defined set of experiments designed to look at the potential effects of the API on three trophic life forms and bacteria, along with other experimentally determined/calculated figures that will give some idea of the PBT risk of the API.
For some years in Sweden, data from the ERA has been made available to payers and prescribers in their database (www.fass.se). At a high level, fass.se was designed to promote the prescription of drugs with the lowest environmental fate impact, whilst ensuring that the clinical benefits are equal for the patient. Some stakeholders would like consideration of the ERA to become part of the marketing authorisation for new pharmaceutical products.
The ERA for an API runs through a number of phases, involving successive levels designed to generate more data if concern around a particular substance increases. The ERA is principally based around two figures: the calculated Predicted Environmental Concentration (PEC) of the API in the environment (water) and the measured concentration at which no adverse environmental issues would be expected (Predicted No Effect Concentration – PNEC). Many ERAs and the data submitted to regulatory agencies are in the public domain and can also be found by searching the FDA/EMA websites.
Many pharmaceutical companies carry out and publish studies above and beyond those needed from a regulatory requirement. The regulatory requirement focuses mainly on the fate of the API in the aqueous environment, which is where pharmaceutical residues are most likely destined.