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1H a/b/c - Pesticides, pharmaceuticals, perfluoroalkylated substances, antibiotics (WEP/23) Environmental Risk Assessment of human drugs in respect of the European Union and the American Food and Drug Administration. Huschek, Gerd1, Anja, Kayser1, Hansen, Peter D.2, Hans H., Maurer3, 1 IEQ Institute of Environmental Protection and Quality Assurance Dr. Krengel Ltd, Potsdam, Brandenburg, Germany2 Department of Ecotoxicology, Technical University of Berlin, Berlin, Berlin, Germany3 Department of Experimental and Clinical Toxicology, University of Saarland, Homburg (Saar), Saarland ABSTRACT- An environmental risk assessment is presented for the selected pharmaceutical group of 111 human drugs with the highest sales in Germany in respect to new recommendations of the European Union and the United States Food and Drug Administration (FDA). The data requirement for environmental exposure assessment were respected by analysing: (1) sales of the 2754 active pharmaceutical substances (1999) placed on the German market per annum in [kg] or [IU] for all pharmaceuticals sold by pharmacies (with/without prescription) or used in hospitals in 1996-2001 at and hospital; (2) use pattern in respect of the Anatomical Therapeutic Chemical (ATC) classification index ATC3 of European pharmaceutical Marketing Research Association (EphMRA) and ATC7 of the World Health Organization / Wissenschaftliches Institut der Allgemeinen Ortskrankenkassen (WHO / WIdO) for the drugs; (3) data to excretion, toxicity and metabolites of the 111 selected human drugs and (4) physico-chemical properties of the 111 substances and (5) effluent samples of two sewage treatment plants (STPs) with a validated and accredited liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. A correction factor for pharmaceutical therapeutically activity of metabolites the PT Index (excretion rate / 100) for drugs and PT active metabolites was established to evaluate the Predicted Environmental Concentration (PECSURFACE-WATER) respectively Environmental Impact Concentration (EICAquatic) formula with human excretion rates of analytical forms of detection to regard environmental health effects. In addition, crude environmental effect analysis for the compartment water were estimated by determination of predicted environmental concentration (PEC) / predicted no effect concentration (PNEC) ratios. The calculated PEC results are compared with exposure results of effluents of STP. An ecotoxicological concept will be discussed to link environmental and human effects of drugs in consideration of Toxicity Identification Evaluation (TIE) strategy, ecotoxicity phase 1 for veterinary medicinal products and new methods of effect-bio monitoring. Finally, results of a patent specification to separate selected human drug residues determined by controlling STP effluents in wastewater are presented. Key words: drug metabolites excretion forms, ERA (EIA), elimination of drug residues, LC-MS/MS |
