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A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs

Americans fill upward of four billion prescriptions for pharmaceuticals each year, and many of those pharmaceuticals eventually make their way into the environment. Hundreds of different active pharmaceutical ingredients (APIs) are detected in ambient waters and source water used for drinking water...

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Detalles Bibliográficos
Autores principales: Suchomel, Ashley, Goeden, Helen, Dady, Julia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069140/
https://www.ncbi.nlm.nih.gov/pubmed/29932115
http://dx.doi.org/10.3390/ijerph15071308
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author Suchomel, Ashley
Goeden, Helen
Dady, Julia
author_facet Suchomel, Ashley
Goeden, Helen
Dady, Julia
author_sort Suchomel, Ashley
collection PubMed
description Americans fill upward of four billion prescriptions for pharmaceuticals each year, and many of those pharmaceuticals eventually make their way into the environment. Hundreds of different active pharmaceutical ingredients (APIs) are detected in ambient waters and source water used for drinking water in the U.S. Very few of these drugs have health-based guidance values that suggest a safe level for individuals exposed in the ambient environment through drinking water. The Minnesota Department of Health (MDH) has developed a novel method to derive screening-level human health guidance values for APIs. This method was designed for rapid evaluation and relies on Food and Drug Administration (FDA)-approved drug labels and limited additional public data resources for necessary information. MDH developed an analytical framework using traditional and novel uncertainty and adjustment factors specific to the information available for APIs. This framework, along with an estimated lowest therapeutic dose (LTD), was used to derive screening reference dose (sRfD) values. Water screening values (WSV) were then derived using the sRfD, a relative source contribution factor (RSC), and a water intake rate for infants to represent a highly exposed population. MDH used this new method to derive water screening values for 119 APIs that are commonly prescribed and/or commonly monitored in Minnesota waters, including antibiotics, antidepressants, steroids, and other classes of drugs. The derived WSVs can be used to provide context to environmental detections, prioritize APIs for further health-based guidance development, prioritize APIs for future environmental monitoring studies, and inform the development or refinement of analytical methods.
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spelling pubmed-60691402018-08-07 A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs Suchomel, Ashley Goeden, Helen Dady, Julia Int J Environ Res Public Health Article Americans fill upward of four billion prescriptions for pharmaceuticals each year, and many of those pharmaceuticals eventually make their way into the environment. Hundreds of different active pharmaceutical ingredients (APIs) are detected in ambient waters and source water used for drinking water in the U.S. Very few of these drugs have health-based guidance values that suggest a safe level for individuals exposed in the ambient environment through drinking water. The Minnesota Department of Health (MDH) has developed a novel method to derive screening-level human health guidance values for APIs. This method was designed for rapid evaluation and relies on Food and Drug Administration (FDA)-approved drug labels and limited additional public data resources for necessary information. MDH developed an analytical framework using traditional and novel uncertainty and adjustment factors specific to the information available for APIs. This framework, along with an estimated lowest therapeutic dose (LTD), was used to derive screening reference dose (sRfD) values. Water screening values (WSV) were then derived using the sRfD, a relative source contribution factor (RSC), and a water intake rate for infants to represent a highly exposed population. MDH used this new method to derive water screening values for 119 APIs that are commonly prescribed and/or commonly monitored in Minnesota waters, including antibiotics, antidepressants, steroids, and other classes of drugs. The derived WSVs can be used to provide context to environmental detections, prioritize APIs for further health-based guidance development, prioritize APIs for future environmental monitoring studies, and inform the development or refinement of analytical methods. MDPI 2018-06-22 2018-07 /pmc/articles/PMC6069140/ /pubmed/29932115 http://dx.doi.org/10.3390/ijerph15071308 Text en © 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Suchomel, Ashley
Goeden, Helen
Dady, Julia
A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs
title A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs
title_full A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs
title_fullStr A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs
title_full_unstemmed A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs
title_short A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs
title_sort method for developing rapid screening values for active pharmaceutical ingredients (apis) in water and results of initial application for 119 apis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069140/
https://www.ncbi.nlm.nih.gov/pubmed/29932115
http://dx.doi.org/10.3390/ijerph15071308
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