Human and Veterinary Pharmaceuticals

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Environmental risk assessment of pharmaceuticals

Increasing widespread human and veterinary use of pharmaceuticals has highlighted the importance of assessing and evaluating the effects these substances have on the environment. Demand for such action has resulted in the introduction and adoption of test guidelines by regulatory, governmental and scientific bodies. Fraunhofer IME uses these test guidelines to perform tests required for the approval of pharmaceuticals, including offering modified standard studies on the fate and effects of human and veterinary pharmaceuticals in the environment.

Examples for veterinary pharmaceuticals are investigations on their degradability in soils (OECD TG 307), on adsorption/desorption (OECD TG 106) and on their effects on aquatic organisms (OECD TG 201, 221, 202, 211, 203, 204 und 215) and terrestrial organisms (e.g. OECD TG 216, 217, 207, 222, 208 and 227).

Human pharmaceuticals are tested for their environmental friendliness with tests such as OECD TG 307 and 308 (fate in soil and sediment), OECD TG 305 (bioaccumulation), as well as OECD TG 210, 211 (aquatic organisms), 207/208, 216 and ISO 11267 (terrestrial organisms).

Environmental assessment and preparation of dossiers is also offered in co-operation with other Fraunhofer institutes.

An important path of entry of veterinary pharmaceuticals into the environment is via agricultural manure application. In 2011 the European Medicines Agency (EMA) introduced a guidance document that provides a framework for the determination of veterinary pharmaceutical behaviour in manure. The practical implementation of the guidance document has result in a test guideline being developed, with intensive German participation (German Federal Environment Agency). On behalf of the German Federal Environment Agency, Fraunhofer IME and other German partners are performing preliminary experimental investigations.

Studies on hazard and risk assessment



Simon, M., Herrchen, M., Graf, N., Förster, B., Römbke, J.:
Concept development for an extended plant test in the environmental risk assessment of veterinary medicinal products. UBA/Texte 15/2015; Umweltbundesamt, Dessau, 270 S. (ISSN 1862-4804) (Download)

Richter E., Berkner S., Ebert I., Förster B., Graf N., Herrchen M., Kühnen U., Römbke J., Simon M.:
Results of extended plant tests using more realistic exposure scenarios for improving environmental risk assessment of veterinary pharmaceuticals. Environ Sci Eur. 2016;28(1):22. Epub 2016 Aug 9.

Liebig, M., Floeter, C., Hahn, T., Koch, W., Wenzel, A., Römbke, J.:
Risk mitigation measures: An important aspect of the environmental risk assessment of pharmaceuticals. Toxics [online] 2 (2014) No. 1: 35–49 (DOI: 10.3390/toxics2010035)

Subedi, B., Du, B., Chambliss, C. K., Koschorreck, J., Rüdel, H., Quack, M., Brooks, B. W., Usenko, S.:
Occurrence of pharmaceuticals and personal care products in German fish tissue: A national study.
Environmental Science and Technology 46 (2012) No. 16: 9047 - 9054
(DOI: 10.1021/es301359t)

Hund-Rinke K, Simon M, Lukow, T:
Effects of Tetracycline on the Soil Microflora: Function, Diversity, Resistance.
Journal of Soils and Sediments, Vol. 4 (1) 2004: 11-16  

Schäfers C:
Auswirkungen von Arzneimitteln und endokrin wirksamen Substanzen auf die aquatische Lebensgemeinschaft. In : Track T, Kreysa (eds) Spurenstoffe in Gewässern. WILEY-VCH VerlagGmbH & Co KGaA, Weinheim (2003) 47-60
(DOI: 10.1002/3527606599.ch4)