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A framework to Identify High-Priority Legacy Active Pharmaceutical Ingredients for Environmental Risk Assessment.

Cristiana Cannata1, Erika Colombo2, Ashenafi Legehar3

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Summary
This summary is machine-generated.

A new framework prioritizes legacy Active Pharmaceutical Ingredients (APIs) in surface waters for environmental risk assessments (ERAs). This approach identifies high-risk pharmaceuticals, guiding further testing and regulatory action to protect aquatic ecosystems.

Keywords:
Environmental Risk AssessmentIn silicoPharmaceuticalsPrioritisation

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Area of Science:

  • Environmental Chemistry
  • Ecotoxicology
  • Risk Assessment

Background:

  • Active Pharmaceutical Ingredients (APIs) are prevalent in global surface waters, posing unknown ecological risks.
  • Environmental Risk Assessments (ERAs) for all pharmaceuticals, especially legacy ones, are unfeasible.
  • Prioritizing legacy APIs for ERA is crucial, as proposed by EU pharmaceutical legislation.

Purpose of the Study:

  • To develop and apply a risk-based prioritization framework for identifying legacy APIs requiring further ERA.
  • To screen a large dataset of APIs to identify those with potential environmental risks.

Main Methods:

  • Estimated environmental concentrations using European sales data (2019-2023).
  • Predicted effect concentrations using Quantitative Structure-Activity Relationship (QSAR) models and Therapeutic Water Concentrations (TWCs).
  • Calculated preliminary risk quotients (pRQs) and ranked APIs based on combined exposure and effect data.

Main Results:

  • QSAR models tended to underestimate highly toxic pharmaceutical effects, while TWCs showed greater variability.
  • A final risk-based ranking of legacy APIs was generated, highlighting those needing further assessment.
  • Data availability for ERA was summarized, aiding in identifying knowledge gaps.

Conclusions:

  • The developed framework effectively screens legacy APIs for environmental risk prioritization.
  • This approach supports regulators and industry in making informed decisions about further ERA and testing needs.
  • It provides a crucial starting point for managing pharmaceutical pollution in aquatic environments.