Environmentally Safe and Just Pharmacy: A Framework and Action Plan for Operating within the Earth System Boundary for Novel Entities

Active pharmaceutical ingredients (APIs) are essential for global health, yet their use and release into the environment contribute to the transgression of the Earth System Boundary for Novel Entities. This study proposes a novel framework for an Environmentally Safe and Just Pharmacy, establishing 4 overarching criteria and 12 subcriteria designed to ensure that the pharmaceutical lifecycle is environmentally safe and just from a novel entities perspective. Using the extensive expertise of our global author group, we conclude that current practices for API design and development, approval and monitoring, use and disposal are only partially or poorly aligned with our criteria. Key vulnerabilities include a lack of environmental considerations in early-stage drug design, widespread exceedances of environmental concentrations deemed safe to ecosystems, persistent selection for antimicrobial resistance in the environment, and severe data gaps in low- and middle-income countries. We further highlight environmental injustices, particularly for Indigenous and marginalized communities whose cultural identities and livelihoods are compromised by chemical contamination. To address these challenges, we present a 10-point roadmap for a transition to a sustainable future by 2050. This plan includes calls for green chemistry investments, the integration of social and cultural equity into risk assessments, and the global upgrade of treatment and management infrastructure. We emphasize that solutions to pharmaceutical impacts must be culturally sensitive and safeguard the dignity of vulnerable populations to ensure a truly just transition that operates within Earth System Boundaries.