Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare
REVIEW article
Front. Drug Saf. Regul.
Sec. Substance-Based Medical Devices
Volume 4 – 2024 |
doi: 10.3389/fdsfr.2024.1519142
Provisionally accepted
- 1
Aboca (Italy), Sansepolcro, Italy - 2
University of Pavia, Pavia, Lombardy, Italy
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, health care 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.
Keywords:
benefit-risk assessment, environmental risk, One Health, greener pharmacy, biodegradability, medical devices made of substances Abbreviations: API, active pharmaceutical ingredients, ECHA, European Chemicals Agency, EPA, Environmental protection agency, EU, European Union, NIH, National Institutes of Health, REACH, Registration, Evaluation, Authorisation and Restriction of Chemicals
Received:
29 Oct 2024;
Accepted:
24 Dec 2024.
Copyright:
© 2024 Giovagnoni, Mattoli, Cossu and Murgia. This is an
open-access article distributed under the terms of the
Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted,
provided the original author(s) or licensor are credited and that the
original publication in this journal is cited, in accordance with accepted
academic practice. No use, distribution or reproduction is permitted which
does not comply with these terms.
* Correspondence:
Andrea Cossu, Aboca (Italy), Sansepolcro, Italy
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