Global Guidance to Tackle Antibiotic Pollution
Context:
The World Health Organization (WHO) has issued its first-ever global guidance titled Guidance on wastewater and solid waste management for manufacturing of antibiotics.
More on News:
- The document aims to provide a scientific framework for regulators, industry players, and other stakeholders to implement effective controls against antibiotic pollution.
- Addresses the critical issue of wastewater and solid waste management in the production of antibiotics (a contributor to antimicrobial resistance).
The Challenge of Antibiotic Pollution
- Antibiotic pollution occurs when residues from the manufacturing of antibiotics are released into the environment (into local waterways).
- Despite the high levels of antibiotic pollution being well-documented, the issue remains largely unregulated, with quality assurance criteria typically not addressing environmental emissions.
- The new WHO guidance provides a comprehensive framework for managing both liquid and solid wastes from antibiotic manufacturing facilities.
AMR occurs when bacteria, viruses, fungi, and parasites become resistant to medicines, resulting in more severe illnesses and harder-to-treat infections, which can lead to increased morbidity and mortality. Antibiotic discharge from manufacturing is a major contributor to the rising AMR crisis.
Key Highlights and Recommendations:
The guidance was developed in collaboration with representatives from academia, regulatory bodies, and international organisations such as the United Nations Environment Programme (UNEP).
- The guidance sets targets to reduce AMR risks to human health and aquatic life from all antibiotics used for human, animal, or plant purposes.
- It covers the entire production process, from the manufacturing of active pharmaceutical ingredients (APIs) to the formulation of finished products and primary packaging.
- It bears similarities to the AMR Industry Alliance standard but includes additional requirements, such as a two-level approach (‘good’ and ‘stringent’) and specified limits on mass balance calculations.
Key Elements of the Guidance:
- Defining Targets: Establishing goals for resistance selection and ecological effects based on exposure and risk assessments.
- Risk Management Processes: Implementing recognised risk management tools, such as hazard analysis and critical control points (HACCP), alongside internal audits and public communications to achieve the defined targets.
- Independent Audits: Conduct audits to verify compliance with the defined targets.
Various international bodies, including the WHO Executive Board, G7 health ministers, and UNEP, have called for this guidance. They emphasise the need to carefully consider the environment’s role in the development, transmission, and spread of antimicrobial resistance, as evidence continues to grow. There is broad consensus that addressing environmental factors must be a key part of the solution, encompassing pollution prevention and control in municipal systems, manufacturing sites, healthcare facilities, and agri-food systems.