Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)

The European Medicines Agency (EMA) mandates Environmental Risk Assessments (ERAs) since 2006 to determine potential risks of new marketed medicines. Drugs with a Predicted Environmental Concentration (PEC) in inland surface waters exceeding 0.01 μg L require further environmental risk assessment. P...

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Detalhes bibliográficos
Autores: Couñago-Fernández, Moisés, Otero, Pablo, Samartín-Ucha, Marisol, Paradela-Carreiro, Adolfo, Muniategui-Lorenzo, Soledad, Martínez-López de Castro, Noemí
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Recursos:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/367211
Acesso em linha:http://hdl.handle.net/10261/367211
Access Level:acceso abierto
Palavra-chave:Anticancer drugs
Risk assessment
Eco-pharmacovigilance
Aquatic environment
Drug pollution
Emerging pollutants
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spelling Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)Couñago-Fernández, MoisésOtero, PabloSamartín-Ucha, MarisolParadela-Carreiro, AdolfoMuniategui-Lorenzo, SoledadMartínez-López de Castro, NoemíAnticancer drugsRisk assessmentEco-pharmacovigilanceAquatic environmentDrug pollutionEmerging pollutantsThe European Medicines Agency (EMA) mandates Environmental Risk Assessments (ERAs) since 2006 to determine potential risks of new marketed medicines. Drugs with a Predicted Environmental Concentration (PEC) in inland surface waters exceeding 0.01 μg L require further environmental risk assessment. PEC may be refined based on prevalence data and/or based on the treatment regimen. In this study, based on EMA regulations, refined PEC of 108 antineoplastic drugs in coastal waters were determined based on the consumption in a coastal health area during 2021, identifying six drugs with potential environmental risk in surface waters (hydroxyurea, capecitabine, abiraterone, ibrutinib, imatinib and 5-fluorouracil) and two in marine ecosystem (hydroxyurea and capecitabine). Comparison of these refined PECs with data from marketing laboratories revealed significant disparities, suggesting the need for regular updates, especially with changes in drug indications or financing. Notably, the identified drugs are not yet on the main reference lists of emerging contaminants.This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.Peer reviewedElsevierConsejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]2024202420242024info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10261/367211reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Ingléshttp://dx.doi.org/10.1016/j.marpolbul.2024.116399Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/3672112026-05-22T06:33:51Z
dc.title.none.fl_str_mv Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)
title Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)
spellingShingle Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)
Couñago-Fernández, Moisés
Anticancer drugs
Risk assessment
Eco-pharmacovigilance
Aquatic environment
Drug pollution
Emerging pollutants
title_short Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)
title_full Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)
title_fullStr Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)
title_full_unstemmed Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)
title_sort Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)
dc.creator.none.fl_str_mv Couñago-Fernández, Moisés
Otero, Pablo
Samartín-Ucha, Marisol
Paradela-Carreiro, Adolfo
Muniategui-Lorenzo, Soledad
Martínez-López de Castro, Noemí
author Couñago-Fernández, Moisés
author_facet Couñago-Fernández, Moisés
Otero, Pablo
Samartín-Ucha, Marisol
Paradela-Carreiro, Adolfo
Muniategui-Lorenzo, Soledad
Martínez-López de Castro, Noemí
author_role author
author2 Otero, Pablo
Samartín-Ucha, Marisol
Paradela-Carreiro, Adolfo
Muniategui-Lorenzo, Soledad
Martínez-López de Castro, Noemí
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv Anticancer drugs
Risk assessment
Eco-pharmacovigilance
Aquatic environment
Drug pollution
Emerging pollutants
topic Anticancer drugs
Risk assessment
Eco-pharmacovigilance
Aquatic environment
Drug pollution
Emerging pollutants
description The European Medicines Agency (EMA) mandates Environmental Risk Assessments (ERAs) since 2006 to determine potential risks of new marketed medicines. Drugs with a Predicted Environmental Concentration (PEC) in inland surface waters exceeding 0.01 μg L require further environmental risk assessment. PEC may be refined based on prevalence data and/or based on the treatment regimen. In this study, based on EMA regulations, refined PEC of 108 antineoplastic drugs in coastal waters were determined based on the consumption in a coastal health area during 2021, identifying six drugs with potential environmental risk in surface waters (hydroxyurea, capecitabine, abiraterone, ibrutinib, imatinib and 5-fluorouracil) and two in marine ecosystem (hydroxyurea and capecitabine). Comparison of these refined PECs with data from marketing laboratories revealed significant disparities, suggesting the need for regular updates, especially with changes in drug indications or financing. Notably, the identified drugs are not yet on the main reference lists of emerging contaminants.
publishDate 2024
dc.date.none.fl_str_mv 2024
2024
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/367211
url http://hdl.handle.net/10261/367211
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv http://dx.doi.org/10.1016/j.marpolbul.2024.116399
Sí
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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