The importance of over-the-counter-sales and product format in the environmental exposure assessment of active pharmaceutical ingredients

T.J. Austin; S. Comber; E. Forrester; M. Gardner; O.R. Price; R. Oldenkamp; A.M.J. Ragas; A.J. Hendriks

doi:10.1016/j.scitotenv.2020.141624

The importance of over-the-counter-sales and product format in the environmental exposure assessment of active pharmaceutical ingredients

T.J. Austin, S. Comber, E. Forrester, M. Gardner, O.R. Price, R. Oldenkamp, A.M.J. Ragas, A.J. Hendriks

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

© 2020 Elsevier B.V.When assessing the environmental exposure of active pharmaceutical ingredients (APIs), the mass contributed from over the counter (OTC) sales are often not included due to difficulty obtaining this data and topical formats are overlooked completely. This study presents a comprehensive approach, investigating the significance of OTC and topical applications as sources of API releases to wastewater, in addition to temporal and subnational variations in use in the UK. The study provides methods to obtain and make use of OTC sales data which can be applied widely. The calculated releases to wastewater compared well with influent concentrations measured at several UK wastewater treatment plants (WWTPs). Consistent overestimation was observed, attributed to a number of factors, including in-sewer removal. OTC sales were found to make up a large proportion of the mass of ibuprofen (76%) and diclofenac (35%) consumed and topical formats were also found to be vital, contributing disproportionately to wastewater loadings per unit mass of ibuprofen and diclofenac used (43% and 99% of the total mass released, respectively). Releases of the APIs investigated did not vary temporally, but regional variation was significant and where possible should be considered for the most accurate exposure assessment of pharmaceuticals.

Original language	English
Article number	141624
Journal	Science of the Total Environment
Volume	752
DOIs	https://doi.org/10.1016/j.scitotenv.2020.141624
Publication status	Published - 15 Jan 2021
Externally published	Yes

Funding

The authors wish to thank the Annette Blackman of IQVIA and Ryan Milburn of Nielsen, for their patience and help in responding to requests for prescription and OTC datasets, the coordinator of the CIP programme UK Water Industry Research (UKWIR) for authorising the use of the information reported here, and the UK Water Utility companies Anglian, Dwr Cymru, Northumbrian, Scottish, Severn Trent, Southern, South West, Thames, United Utilities, Wessex and Yorkshire Water for their considerable efforts in generating it. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Funders	Funder number
CIP programme UK Water Industry Research
UKWIR

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title = "The importance of over-the-counter-sales and product format in the environmental exposure assessment of active pharmaceutical ingredients",

abstract = "{\textcopyright} 2020 Elsevier B.V.When assessing the environmental exposure of active pharmaceutical ingredients (APIs), the mass contributed from over the counter (OTC) sales are often not included due to difficulty obtaining this data and topical formats are overlooked completely. This study presents a comprehensive approach, investigating the significance of OTC and topical applications as sources of API releases to wastewater, in addition to temporal and subnational variations in use in the UK. The study provides methods to obtain and make use of OTC sales data which can be applied widely. The calculated releases to wastewater compared well with influent concentrations measured at several UK wastewater treatment plants (WWTPs). Consistent overestimation was observed, attributed to a number of factors, including in-sewer removal. OTC sales were found to make up a large proportion of the mass of ibuprofen (76%) and diclofenac (35%) consumed and topical formats were also found to be vital, contributing disproportionately to wastewater loadings per unit mass of ibuprofen and diclofenac used (43% and 99% of the total mass released, respectively). Releases of the APIs investigated did not vary temporally, but regional variation was significant and where possible should be considered for the most accurate exposure assessment of pharmaceuticals.",

author = "T.J. Austin and S. Comber and E. Forrester and M. Gardner and O.R. Price and R. Oldenkamp and A.M.J. Ragas and A.J. Hendriks",

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AU - Austin, T.J.

AU - Comber, S.

AU - Forrester, E.

AU - Gardner, M.

AU - Price, O.R.

AU - Oldenkamp, R.

AU - Ragas, A.M.J.

AU - Hendriks, A.J.

PY - 2021/1/15

Y1 - 2021/1/15

N2 - © 2020 Elsevier B.V.When assessing the environmental exposure of active pharmaceutical ingredients (APIs), the mass contributed from over the counter (OTC) sales are often not included due to difficulty obtaining this data and topical formats are overlooked completely. This study presents a comprehensive approach, investigating the significance of OTC and topical applications as sources of API releases to wastewater, in addition to temporal and subnational variations in use in the UK. The study provides methods to obtain and make use of OTC sales data which can be applied widely. The calculated releases to wastewater compared well with influent concentrations measured at several UK wastewater treatment plants (WWTPs). Consistent overestimation was observed, attributed to a number of factors, including in-sewer removal. OTC sales were found to make up a large proportion of the mass of ibuprofen (76%) and diclofenac (35%) consumed and topical formats were also found to be vital, contributing disproportionately to wastewater loadings per unit mass of ibuprofen and diclofenac used (43% and 99% of the total mass released, respectively). Releases of the APIs investigated did not vary temporally, but regional variation was significant and where possible should be considered for the most accurate exposure assessment of pharmaceuticals.

AB - © 2020 Elsevier B.V.When assessing the environmental exposure of active pharmaceutical ingredients (APIs), the mass contributed from over the counter (OTC) sales are often not included due to difficulty obtaining this data and topical formats are overlooked completely. This study presents a comprehensive approach, investigating the significance of OTC and topical applications as sources of API releases to wastewater, in addition to temporal and subnational variations in use in the UK. The study provides methods to obtain and make use of OTC sales data which can be applied widely. The calculated releases to wastewater compared well with influent concentrations measured at several UK wastewater treatment plants (WWTPs). Consistent overestimation was observed, attributed to a number of factors, including in-sewer removal. OTC sales were found to make up a large proportion of the mass of ibuprofen (76%) and diclofenac (35%) consumed and topical formats were also found to be vital, contributing disproportionately to wastewater loadings per unit mass of ibuprofen and diclofenac used (43% and 99% of the total mass released, respectively). Releases of the APIs investigated did not vary temporally, but regional variation was significant and where possible should be considered for the most accurate exposure assessment of pharmaceuticals.

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JO - Science of the Total Environment

JF - Science of the Total Environment

M1 - 141624

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The importance of over-the-counter-sales and product format in the environmental exposure assessment of active pharmaceutical ingredients

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