Stereoisomerism in environmental cycle of pharmacologically active compounds:

a new paradigm in environmental (bio)analysis and risk assessment

Barbara Kasprzyk-Hordern, Maria Camacho-Munoz, Erika Castrignano, Felicity Elder, María Jesús Andrés-Costa, Bruce Petrie, Kathryn Proctor, Jack Rice

Research output: Chapter in Book/Report/Conference proceedingConference contribution

Abstract

Chiral pharmacologically active compounds (cPACs) are biologically active chemicals designed to improve our health. They are also ubiquitous, persistent and ecotoxic environmental pollutants. Surprisingly, the environmental fate and effects of cPACs are assessed without taking into consideration their enantiomeric forms (this is despite existing knowledge of the enantiomer dependant toxicity of cPACs to humans, taking thalidomide as a prime example). The European Medicines Agency (EMEA) guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use [1] recommends the estimation of exposure and the prediction of risk calculation for the whole parent compounds only i.e. as a racemate if prescribed as such. Similarly, the EU Directive for ERA for Veterinary Medicinal Products [2] does not require enantiomer-specific tests to be undertaken for veterinary CMPs. Such an approach could lead to an underestimation of toxicity of PACs, incorrect environmental risk assessment, and direct risk to the environment and human health, as PACs are likely to be present in the environment in their non-racemic forms.
Inappropriate Environmental Risk Assessment (ERA) and lack of compatible, comprehensive and sensitive analytical methods to study the fate and biological effects of cPACs at enantiomeric level is by far the biggest obstacle in unveiling the importance of enantiomerism of pollutants. This talk will introduce the phenomenon of chirality in the context of fate and effects of chiral PACs and their analysis in the environment. Results from our large-scale UK and European monitoring studies and lab scale microcosms will be presented and implications of enantiomer-dependant fate and ecotoxicity of cPACs for procedures applied in environmental risk assessment will be explored.
[1] Guideline on the ERA of medicinal products for human use; European Medicines Agency, Doc. Ref. MEA/CHMP/SWP/4447/00
[2] ERA for Veterinary Medicinal Products other than GMO containing and Immunological Products; EU Directive 81/852/EEC

Original languageEnglish
Title of host publicationEUROANALYSIS 2017
Publication statusPublished - 30 Aug 2017
EventEUROANALYSIS 2017 - Stockholm, Sweden
Duration: 28 Aug 20171 Sep 2017
http://euroanalysis2017.se/

Conference

ConferenceEUROANALYSIS 2017
CountrySweden
CityStockholm
Period28/08/171/09/17
Internet address

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risk assessment
medicine
toxicity
environmental fate
pollutant
analysis
environmental risk assessment
environmental effect
microcosm
analytical method
product
monitoring
prediction
directive

Cite this

Stereoisomerism in environmental cycle of pharmacologically active compounds: a new paradigm in environmental (bio)analysis and risk assessment. / Kasprzyk-Hordern, Barbara; Camacho-Munoz, Maria; Castrignano, Erika; Elder, Felicity; Andrés-Costa, María Jesús; Petrie, Bruce; Proctor, Kathryn; Rice, Jack.

EUROANALYSIS 2017. 2017.

Research output: Chapter in Book/Report/Conference proceedingConference contribution

Kasprzyk-Hordern, B, Camacho-Munoz, M, Castrignano, E, Elder, F, Andrés-Costa, MJ, Petrie, B, Proctor, K & Rice, J 2017, Stereoisomerism in environmental cycle of pharmacologically active compounds: a new paradigm in environmental (bio)analysis and risk assessment. in EUROANALYSIS 2017. EUROANALYSIS 2017, Stockholm, Sweden, 28/08/17.
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abstract = "Chiral pharmacologically active compounds (cPACs) are biologically active chemicals designed to improve our health. They are also ubiquitous, persistent and ecotoxic environmental pollutants. Surprisingly, the environmental fate and effects of cPACs are assessed without taking into consideration their enantiomeric forms (this is despite existing knowledge of the enantiomer dependant toxicity of cPACs to humans, taking thalidomide as a prime example). The European Medicines Agency (EMEA) guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use [1] recommends the estimation of exposure and the prediction of risk calculation for the whole parent compounds only i.e. as a racemate if prescribed as such. Similarly, the EU Directive for ERA for Veterinary Medicinal Products [2] does not require enantiomer-specific tests to be undertaken for veterinary CMPs. Such an approach could lead to an underestimation of toxicity of PACs, incorrect environmental risk assessment, and direct risk to the environment and human health, as PACs are likely to be present in the environment in their non-racemic forms.Inappropriate Environmental Risk Assessment (ERA) and lack of compatible, comprehensive and sensitive analytical methods to study the fate and biological effects of cPACs at enantiomeric level is by far the biggest obstacle in unveiling the importance of enantiomerism of pollutants. This talk will introduce the phenomenon of chirality in the context of fate and effects of chiral PACs and their analysis in the environment. Results from our large-scale UK and European monitoring studies and lab scale microcosms will be presented and implications of enantiomer-dependant fate and ecotoxicity of cPACs for procedures applied in environmental risk assessment will be explored.[1] Guideline on the ERA of medicinal products for human use; European Medicines Agency, Doc. Ref. MEA/CHMP/SWP/4447/00[2] ERA for Veterinary Medicinal Products other than GMO containing and Immunological Products; EU Directive 81/852/EEC",
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AB - Chiral pharmacologically active compounds (cPACs) are biologically active chemicals designed to improve our health. They are also ubiquitous, persistent and ecotoxic environmental pollutants. Surprisingly, the environmental fate and effects of cPACs are assessed without taking into consideration their enantiomeric forms (this is despite existing knowledge of the enantiomer dependant toxicity of cPACs to humans, taking thalidomide as a prime example). The European Medicines Agency (EMEA) guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use [1] recommends the estimation of exposure and the prediction of risk calculation for the whole parent compounds only i.e. as a racemate if prescribed as such. Similarly, the EU Directive for ERA for Veterinary Medicinal Products [2] does not require enantiomer-specific tests to be undertaken for veterinary CMPs. Such an approach could lead to an underestimation of toxicity of PACs, incorrect environmental risk assessment, and direct risk to the environment and human health, as PACs are likely to be present in the environment in their non-racemic forms.Inappropriate Environmental Risk Assessment (ERA) and lack of compatible, comprehensive and sensitive analytical methods to study the fate and biological effects of cPACs at enantiomeric level is by far the biggest obstacle in unveiling the importance of enantiomerism of pollutants. This talk will introduce the phenomenon of chirality in the context of fate and effects of chiral PACs and their analysis in the environment. Results from our large-scale UK and European monitoring studies and lab scale microcosms will be presented and implications of enantiomer-dependant fate and ecotoxicity of cPACs for procedures applied in environmental risk assessment will be explored.[1] Guideline on the ERA of medicinal products for human use; European Medicines Agency, Doc. Ref. MEA/CHMP/SWP/4447/00[2] ERA for Veterinary Medicinal Products other than GMO containing and Immunological Products; EU Directive 81/852/EEC

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