Expert perspectives on potential environmental risks from nanomedicines and adequacy of the current guideline on environmental risk assessment

Abstract

In the next couple of decades, nanotechnology-enabled healthcare applications will significantly influence the diagnosis, prevention and treatment of human diseases. Since pharmaceutical products (PPs) have been detected in various environmental compartments, and low-level chronic exposure to PPs has induced adverse and sometimes unexpected effects on non-target organisms, the question of potential environmental risks from increased usage of nanomedical products arises. The risks and benefits to patients from nanomedicines are the focus of exhaustive evaluation by regulatory agencies; by contrast, risks to the environment from nanomedicines are only briefly considered by regulators and are rarely discussed by nanoscientists. To start to fill this gap, 66 experts from nanomedicine R&D, representatives of research funding agencies and of institutions involved in safeguarding public health and the environment were interviewed using a semi-structured questionnaire regarding possible hazards and risks from nanomedicine and on the adequacy of current the environmental risk assessment (ERA) framework for medicines. The interview recordings were transcribed verbatim and analysed via qualitative content analysis. Experts interviewed commented that hazards were possible but risks were unlikely from nanomedicines due to expected minimal exposure. They qualified their statements by comparing risks from nanomedicine with risks from nanomaterials in other industries, conventional pollutants and larger global issues like climate change. Regarding adequacy of the current risk framework for assessment of environmental risks from nanomedicines, perceptions of experts were more varied; some argued that complete overhaul of the ERA framework was required including changes in toxicity endpoints, whereas others suggested that the framework was adequate, though some adjustments were needed.

The regulation of nanomaterials and nanomedicines for clinical application: current and future perspectives

“…Another factor to consider when contemplating the impact of nanomedicines, is in their possible environmental impact, after use, upon disposal, and during production. 28 It is widely accepted that conventional pharmaceuticals are eventually recovered in the environment and so it is expected that nanomedicines will behave no differently, therefore there is a chance that they could negatively affect the environment. 29 The FDA cite the lack of data to determine the safety to humans and the environment, thus they are struggling to formulate a criterion to ensure safe and efficacious development of nano-products, whether they are a drug, device or biologic.…”

Inorganic and Polymeric Nanoparticles for Human Viral and Bacterial Infections Prevention and Treatment

“…A recent study asserts that gold spheres of 2–20 nm put onto SiO 2 spheres or aggregates of 50–200 nm can inhibit adenovirus reproduction by 90–100% in the range of dilutions from 2.5 × 10 −2 mg/mL to 2.5 × 10 −6 mg/mL and did not show cytotoxicity in vitro [ 65 ]. The potential NPs-based treatment of these diseases is an attractive clinical opportunity that still rises two important issues, (1) the NP-intestine interaction using in vivo model, and (2) the impact of NP on the natural ecosystems and the measures required for minimizing it [ 66 , 67 ] due to this treatment must be ideally orally-administered and, hence, faecally-eliminated.…”

Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials

“…The required, critical properties of nanoforms would be predicted (calculated) with the implemented nanoinformatics tools that are currently under development by the collaborating projects (NanoSolveIT, NanoCommons, and NanoInformaTIX). The framework is expected to support regulatory decision-making as well as business management needs, through the adoption of best practices, the promotion of RRI [97][98][99] and the exploration of frameworks for responsible innovation [100] for integration with the proposed risk governance framework to align policymaking with research practices. Extension to other relevant advanced materials and emerging technologies is also envisaged along with leveraging of best practice from contiguous disciplines.…”