Environmental risk assessment of human and veterinary medicinal products - Challenges and ways of improvement

Abstract

Assessment of the environmental impact, the risk posed by application of medicinal products for human and veterinary use is a legal obligation, and must be performed to evaluate and limit potential adverse effects of medicines on the environment.An environmental risk assessment (ERA) is performed in a stepwise approach in European Union, which starts with an initial screening phase (Phase I), aimed at identifying the environmental exposure of pharmaceuticals based on their potential for bioaccumulation and persistence in the environment. If, following this preliminary assessment, significant environmental exposure is anticipated, or if specific risks are identified due to compound-specific characteristics, a number of studies should be performed (Phase II) based on the guidance documents issued by European Medicines Agency (EMA).The Phase II tests identify the fate of medicinal products in the environment and their potential effects on representative organisms (e.g. fish or daphnids, for the aquatic environment). For this purpose, the results of various internationally accepted test methodologies (laid down mainly by the Organisation for Economic Co-operation and Development (OECD)) form the basis of the risk-assessment process, which may be further extended on a case-by-case basis, depending on the outcome of the assessment.However, several studies have been published revealing considerable residue levels in surface waters, in rivers and lakes throughout Europe that rise the question whether the current legislation and environmental risk assessment system of human and veterinary medicinal products are sufficiently protective.