Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals

被引：11

作者：

Liebig, Markus ^{[1
]}

Floeter, Carolin ^{[2
]}

Hahn, Thorsten ^{[3
]}

Koch, Wolfgang ^{[4
]}

Wenzel, Andrea ^{[5
]}

Rombke, Jorg ^{[1
]}

机构：

[1] ECT Oekotoxikol GmbH, Boettgerstr 2-14, D-65439 Floersheim, Germany

[2] Hamburg Univ Appl Sci HAW, D-21033 Hamburg, Germany

[3] Fraunhofer Inst Toxicol & Expt Med ITEM, D-30625 Hannover, Germany

[4] Fed Environm Agcy, D-06844 Dessau Rosslau, Germany

[5] Fraunhofer Inst Mol Biol & Appl Ecol IME, D-57392 Schmallenberg, Germany

来源：

TOXICS | 2014年 / 2卷 / 01期

关键词：

authorization; environmental risk assessment; medicinal products; risk mitigation;

D O I：

10.3390/toxics2010035

中图分类号：

X [环境科学、安全科学];

学科分类号：

08 ; 0830 ;

摘要：

Within EU marketing authorization procedures of human and veterinary medicinal products (HMP and VMP), an environmental risk assessment (ERA) has to be performed. In the event that an unacceptable environmental risk is identified, risk mitigation measures (RMM) shall be applied in order to reduce environmental exposure to the pharmaceutical. Within the authorization procedures of HMP, no RMM have been applied so far, except for specific precautions for the disposal of the unused medicinal product or waste materials. For VMP, a limited number of RMM do exist. The aim of this study was to develop consistent and efficient RMM. Therefore, existing RMM were compiled from a summary of product characteristics of authorized pharmaceuticals, and new RMM were developed and evaluated. Based on the results, appropriate RMM were applied within the authorization procedures of medicinal products. For HMP, except for the existing precautions for disposal, no further reasonable measures could be developed. For VMP, two specific precautions for disposal and 17 specific precautions for use in animals were proposed as RMM.

引用

页码：35 / 49

页数：15

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