Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare
To mitigate healthcare’s unintended effects, environmental risk data such as ecotoxicity and environmental contamination need to be considered by all stakeholders in the healthcare value chain. As decision-makers and educators, healthcare providers are in a unique position to make healthcare deliver...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Drug Safety and Regulation |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fdsfr.2024.1519142/full |
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| author | Emiliano Giovagnoni Luisa Mattoli Andrea Cossu Vitalia Murgia |
| author_facet | Emiliano Giovagnoni Luisa Mattoli Andrea Cossu Vitalia Murgia |
| author_sort | Emiliano Giovagnoni |
| collection | DOAJ |
| description | To mitigate healthcare’s unintended effects, environmental risk data such as ecotoxicity and environmental contamination need to be considered by all stakeholders in the healthcare value chain. As decision-makers and educators, healthcare providers are in a unique position to make healthcare delivery more sustainable. However, current benefit-risk assessments of therapeutic products do not systematically include environmental risk data. The purpose of this paper was to review the literature and regulatory context and propose expanding benefit-risk assessments of therapeutic products to include an evidence-based evaluation of environmental impact to inform decision-making. Our findings indicate that environmental risk assessments need to be broadened to include aspects such as excipients, synergistic effects of contaminants, and risks to humans (e.g., drinking water). Concrete proposals to improve current regulatory guidelines for environmental risk assessment already exist. Open access databases on environmental risk of substances used in products for human consumption are available. The European Union Regulation on Medical Devices provides the basis for evidence-based approach to developing sustainable therapeutic products based on natural substances. Based on this, the here promoted decision scheme for healthcare providers (and other stakeholders) involves comparing the clinical safety and efficacy of therapeutic products; comparing environmental impact data; and then deciding. A case example involving the treatment of patients with gastroesophageal reflux and dyspepsia is presented. We provide suggestions for integrating persistence and ecotoxicity data into clinical practice. Expanding the benefit-risk assessment to include data on environmental impact during clinical decision-making is a way to achieve a healthier outcome for all. |
| format | Article |
| id | doaj-art-e6d175f81d5846019b66e4ee12673c7b |
| institution | DOAJ |
| issn | 2674-0869 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Drug Safety and Regulation |
| spelling | doaj-art-e6d175f81d5846019b66e4ee12673c7b2025-08-20T02:46:40ZengFrontiers Media S.A.Frontiers in Drug Safety and Regulation2674-08692025-01-01410.3389/fdsfr.2024.15191421519142Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcareEmiliano Giovagnoni0Luisa Mattoli1Andrea Cossu2Vitalia Murgia3Aboca S.p.A., Loc. Aboca, Sansepolcro, ItalyAboca S.p.A., Loc. Aboca, Sansepolcro, ItalyAboca S.p.A., Loc. Aboca, Sansepolcro, ItalyPediatric Unit, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, ItalyTo mitigate healthcare’s unintended effects, environmental risk data such as ecotoxicity and environmental contamination need to be considered by all stakeholders in the healthcare value chain. As decision-makers and educators, healthcare providers are in a unique position to make healthcare delivery more sustainable. However, current benefit-risk assessments of therapeutic products do not systematically include environmental risk data. The purpose of this paper was to review the literature and regulatory context and propose expanding benefit-risk assessments of therapeutic products to include an evidence-based evaluation of environmental impact to inform decision-making. Our findings indicate that environmental risk assessments need to be broadened to include aspects such as excipients, synergistic effects of contaminants, and risks to humans (e.g., drinking water). Concrete proposals to improve current regulatory guidelines for environmental risk assessment already exist. Open access databases on environmental risk of substances used in products for human consumption are available. The European Union Regulation on Medical Devices provides the basis for evidence-based approach to developing sustainable therapeutic products based on natural substances. Based on this, the here promoted decision scheme for healthcare providers (and other stakeholders) involves comparing the clinical safety and efficacy of therapeutic products; comparing environmental impact data; and then deciding. A case example involving the treatment of patients with gastroesophageal reflux and dyspepsia is presented. We provide suggestions for integrating persistence and ecotoxicity data into clinical practice. Expanding the benefit-risk assessment to include data on environmental impact during clinical decision-making is a way to achieve a healthier outcome for all.https://www.frontiersin.org/articles/10.3389/fdsfr.2024.1519142/fullbenefit-risk assessmentenvironmental riskone healthgreener pharmacybiodegradabilitymedical devices made of substances |
| spellingShingle | Emiliano Giovagnoni Luisa Mattoli Andrea Cossu Vitalia Murgia Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare Frontiers in Drug Safety and Regulation benefit-risk assessment environmental risk one health greener pharmacy biodegradability medical devices made of substances |
| title | Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare |
| title_full | Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare |
| title_fullStr | Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare |
| title_full_unstemmed | Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare |
| title_short | Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare |
| title_sort | integrating environmental effects in the benefit risk assessment of therapeutic products a proposal and example for sustainable health and healthcare |
| topic | benefit-risk assessment environmental risk one health greener pharmacy biodegradability medical devices made of substances |
| url | https://www.frontiersin.org/articles/10.3389/fdsfr.2024.1519142/full |
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