WHO Issues Guidance on Antibiotic Pollution from Manufacturing

On Sept. 3, the World Health Organization (WHO) published guidance on antibiotic pollution from manufacturing. The new guidance on wastewater and solid waste management for antibiotic manufacturing sheds light on this important but neglected challenge ahead of the United Nations General Assembly (UNGA) High-Level Meeting on antimicrobial resistance (AMR) taking place on Sept. 26.

A press release on the guidance says that “The emergence and spread of AMR caused by antibiotic pollution could undermine the effectiveness of antibiotics globally, including the medicines produced at the manufacturing sites responsible for the pollution.”

Further, “Despite high antibiotic pollution levels being widely documented, the issue is largely unregulated and quality assurance criteria typically do not address environmental emissions. In addition, once distributed, there is a lack of information provided to consumers on how to dispose of antibiotics when they are not used, for example, when they expire or when a course is finished but there is still antibiotic left over.”

Globally, there is a lack of accessible information on the environmental damage caused by manufacturing of medicines.

A range of international bodies have called for this guidance, including the WHO Executive Board, the G7 health ministers and UNEP.

The guidance was developed with a diverse group of experts representing academia, regulators, inspectors, international organizations such as UNEP, and other sectors. The draft also underwent public consultation.

The press release adds “The guidance provides human health-based targets to reduce the risk of emergence and spread of AMR, as well as targets to address risks for aquatic life caused by all antibiotics intended for human, animal or plant use. It covers all steps from the manufacturing of active pharmaceutical ingredients (APIs) and formulation into finished products, including primary packaging.”