July 5, 2019 by Dean Leverett

Dean and Becky Marks have recently co-authored a paper, Pharmacology beyond the patient – The environmental risks of human drugs with pharmaceutical industry and academic colleagues on the Environmental Risk Assessment (ERA) of pharmaceuticals.

The objective of this study was to undertake a comprehensive analysis of regulatory aquatic ecotoxicity data for pharmaceuticals and assess the effectiveness of the triggers and effects-based requirements prescribed by existing European and US guidance on pharmaceutical ERA. This may assist in facilitating the development of more efficient approaches for the ecotoxicity testing of active pharmaceutical ingredients (APIs).

The study compiled publicly-available regulatory-compliant ecotoxicity data on APIs, along with information on drug targets, human therapeutic plasma concentrations, and lipophilicity, to evaluate potential links between such factors and effects on growth, mortality and reproduction of environmental receptors. Environmental risks were assessed based on an analysis combining API ecotoxicity and predicted environmental concentrations (based on European patient consumption data).

The paper highlights that:

  • 88% of drugs targeting human proteins do not have comprehensive environmental toxicity data.
  • The presence/absence of drug-targets is predictive of the most susceptible species.
  • Drugs targeting the endocrine system represent the highest potency and risk.
  • Most drugs were predicted to pose low environmental risk based on standardized endpoints.

The resultant analysis provides an essential guide in guiding improvements to current testing procedures for APIs, and should assist in approaches for prioritising legacy drugs (i.e. those registered before 2006) for further ecotoxicity testing.

The full paper has been published in Environment International; and can be found here.