title: An integrated approach for prioritizing pharmaceuticals found in the environment for risk assessment, monitoring and advanced research.
abstract: Numerous active pharmaceutical ingredients (APIs), approved prior to enactment of detailed environmental risk assessment (ERA) guidance in the EU in 2006, have been detected in surface waters as a result of advancements in analytical technologies. Without adequate knowledge of the potential hazards these APIs may pose, assessing their environmental risk is challenging. As it would be impractical to commence hazard characterization and ERA en masse, several approaches to prioritizing substances for further attention have been published. Here, through the combination of three presentations given at a recent conference, "Pharmaceuticals in the Environment, Is there a problem?" (Nîmes, France, June 2013) we review several of these approaches, identify salient components, and present available techniques and tools that could facilitate a pragmatic, scientifically sound approach to prioritizing APIs for advanced study or ERA and, where warranted, fill critical data gaps through targeted, intelligent testing. We further present a modest proposal to facilitate future prioritization efforts and advanced research studies that incorporates mammalian pharmacology data (e.g., adverse outcomes pathways and the fish plasma model) and modeled exposure data based on pharmaceutical use.
authors.affiliation: Johnson & Johnson, New Brunswick, NJ, USA. Electronic address: dcaldwel@its.jnj.com.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Caldwell
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Mastrocco
authors.affiliation: Institute for the Environment, Brunel University, Uxbridge, Middlesex, United Kingdom.
authors.forename: Luigi
authors.initials: L
authors.lastname: Margiotta-Casaluci
authors.affiliation: Department of Environmental Science, Center for Reservoir and Aquatic Systems Research, Baylor University, Waco, TX, USA.
authors.forename: Bryan W
authors.initials: BW
authors.lastname: Brooks
mesh_terms: D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology; D004781:Environmental Exposure / Q000009:adverse effects* / Q000032:analysis*; D004784:Environmental Monitoring / Q000379:methods; D004785:Environmental Pollutants / Q000032:analysis*; D006801:Humans; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000032:analysis*; D064798:Polypharmacology; D018570:Risk Assessment / Q000379:methods*
chemical_list: D004785:Environmental Pollutants; D004364:Pharmaceutical Preparations
keywords: Adverse outcome pathways; Environmental risk assessment; Intelligent testing; Pharmaceuticals in the environment; Prioritization