Scientific Evidence

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.

Artificial sweeteners (ASs) and dyes are widely used in foods, beverages and pharmaceutical and are recognized as emerging environmental contaminants due to their persistence and widespread occurrence. These substances often pass through the human body unchanged and resist wastewater treatment processes, leading to continuous introduction into aquatic environments and potential long-lasting term environmental effects.

This study investigated, for the first time, the biodegradability of nine commercial dietary supplements, both natural and those containing ASs and synthetic dyes, using the Organisation for Economic Cooperation and Development (OECD) 301¿F ready biodegradation test (RBT), which is a respirometry-manometric method. While the products showed good biodegradability, those containing ASs and dyes were further studied to determine their fate at the end of the RBT. The study involved developing and validating a chromatographic method to quantitatively determine the presence of Acesulfame K (1), Sucralose (2), Tartrazine (3) and Carmoisine (4) in the RBT mineral medium, using ultra-high performance liquid chromatography (UHPLC) coupled with two detectors: a high-resolution mass-spectrometer with quadrupole time-of-flight (qToF) and a UV-Vis diode array detector (DAD). Results indicated that these additives were not readily biodegraded, highlighting a potential significant environmental concern. This issue extends beyond dietary supplements to all Pharmaceutical and Personal Care Products (PPCP) including drugs and medical devices.

The findings underscore the importance of raising cultural awareness about the environmental impact of persistent substances, encouraging the healthcare chain and patients to make informed choices. From a One Health perspective, reducing environmental contamination can lead to positive outcomes for human health.

Pharmaceutical products have contributed to improving the expectancy and quality of life of millions of patients and their role in our society is undisputed. However, many active pharmaceutical ingredients have been found in rivers, lakes, seas, drinking water and can cause damage to the environment and ecosystems. Environmental contamination is known to affect biodiversity and health. From a "One Health" perspective, human health is safeguarded by preserving the environment and ecosystems. Italy is at the forefront on the issue of protecting biodiversity, having included it among the fundamental principles of the Constitution. At the same time the European Commission launched the strategy to protect biodiversity by 2030. To map and limit the environmental effect of drugs, it has been proposed the topic of ecopharmacovigilance and eco-directed sustainable prescribing.

It's in this context that this work on the ready biodegradability of a drug-based on loperamide and a medical device made of complex natural matrix, Lenodiar-Pediatric®, was carried out for the first time. The products, indicated to treat diarrhoea, were found to be readily biodegradable. For Lenodiar-Pediatric® the biodegradation isn't surprising, while for the drug-based on loperamide it was due to the degradation of excipients. Indeed, the UHPLC-qToF investigation highlighted that loperamide was present at the end of the test and is therefore potentially persistent in the environment, confirming the most relevant literature.

In conclusion, therapeutic products made of natural complex matrix which efficacy and safety have been proven according to Evidence-Based Standards may play an important role in safeguarding biodiversity.