The World Health Organization (WHO) has published its first-ever guidelines on antibiotic contamination from manufacturing. The new guidelines on wastewater and solid waste management for antibiotic production shed light on this important yet neglected issue ahead of the United Nations General Assembly (UNGA) High-Level Meeting on Antimicrobial Resistance (AMR) to be held on 26 September 2024.
The emergence and spread of AMR caused by antibiotic contamination has the potential to globally undermine the effectiveness of antibiotics, including medicines produced at contaminated manufacturing sites.
Despite the widespread documented high levels of contamination from antibiotics, the issue is largely unregulated and quality assurance standards typically make no mention of environmental emissions. Furthermore, consumers are not provided with information on how to dispose of antibiotics once they have been distributed and are not being used, for example if they have expired or if there is still antibiotic remaining after the expiration date has been reached.
“Pharmaceutical waste from antibiotic production can fuel the emergence of new antimicrobial-resistant bacteria, which can spread worldwide and threaten our health. Controlling pollution from antibiotic production helps keep these life-saving medicines effective for all,” said Dr Yukiko Nakatani, WHO Interim Assistant Director-General for AMR.
Globally, there is a lack of information on the environmental damage caused by medicines manufacturing. “These guidelines provide an independent and unbiased scientific basis for regulators, procurement agencies, inspectors and the industry itself to incorporate rigorous antibiotic contamination controls into their standards,” said Dr Maria Neira, Director of WHO’s Department of Environment, Climate Change and Health. “Crucially, the focus on transparency will enable purchasers, investors and the public to make decisions that take into account manufacturers’ efforts to control antibiotic contamination.”
The guidance has been called for by a range of international organisations, including the WHO Executive Committee, G7 Health Ministers and UNEP. “Evidence is mounting about the role of the environment in the emergence, transmission and spread of antimicrobial resistance and needs to be considered carefully. There is broad agreement that the solution requires a greater focus on environmental measures. This includes preventing and controlling contamination from municipal systems, manufacturing sites, health care facilities and agri-food systems,” said Jacqueline Alvarez, Director of Industry and Economics at the United Nations Environment Programme (UNEP).
The guidance was developed in close collaboration with a diverse group of international experts representing academia, regulators, inspectors, international organizations such as UNEP, and other sectors. The draft also underwent public consultation, receiving valuable input from industry and other stakeholders. Industry is also working on this challenge, but it is a voluntary, industry-led effort and may be updated in some areas to coincide with new guidance.
The guidance sets out human health-based goals to reduce the risk of the emergence and spread of AMR, as well as targets to address the risks to aquatic life posed by all antibiotics intended for human, animal and plant use. The guidance covers all steps from active pharmaceutical ingredients (API) manufacturing and formulation to finished products, including primary packaging.
AMR occurs when bacteria, viruses, fungi and parasites no longer respond to medicines, leading to poorer health and an increased risk of spread of hard-to-treat infections, illness and death. AMR is primarily caused by the misuse and overuse of antimicrobials, but at the same time, many people around the world lack access to essential antimicrobials.