Antibiotic production waste fuelling drug-resistant bacteria, warns WHO

In a first, the World Health Organization (WHO) has issued norms on managing waste during antibiotic production

The rise and spread of Antimicrobial Resistance (AMR) due to antibiotic pollution poses a significant threat to the global effectiveness of antibiotics, according to the World Health Organization (WHO). This includes antibiotics manufactured at sites responsible for the pollution itself.

In its maiden guidance on antibiotic pollution from manufacturing, the WHO noted that despite widespread documentation of high antibiotic pollution, the issue remains largely unregulated. Besides, existing quality assurance standards often fail to address the environmental emissions involved in the production process.

Guidance for waste management in antibiotic manufacturing

Ahead of the United Nations General Assembly (UNGA) high-level meeting on AMR, set for September 26, 2024, WHO's guidelines point out the lack of public guidance on how consumers should dispose of unused or expired antibiotics, increasing the risk of improper disposal and environmental contamination.

“Pharmaceutical waste from antibiotic manufacturing can lead to the development of drug-resistant bacteria, which can spread globally, threatening public health,” said Dr Yukiko Nakatani, WHO Assistant Director-General for AMR ad interim. Controlling pollution from these sources, she explained, is vital to preserving the efficacy of antibiotics for all.

Globally, there is insufficient information available regarding the environmental harm caused by pharmaceutical production, said the report. “This guidance offers an independent, scientific basis for regulators, inspectors, and the industry to adopt stringent antibiotic pollution controls,” said Dr Maria Neira, WHO Director of the Department of Environment, Climate Change and Health.

Underlining the importance of transparency, Dr Neira highlighted that the guidance would enable buyers and the public to consider manufacturers' efforts to manage pollution when making decisions.

Global collaboration to tackle AMR

The call for such guidance has been echoed by numerous international bodies, including the WHO Executive Board, G7 health ministers, and the United Nations Environment Programme (UNEP). Jacqueline Alvarez, chief of branch for UNEP's Industry and Economy Division, stressed the importance of addressing the role of the environment in the spread of AMR. "Pollution prevention and control across manufacturing sites, municipal systems, healthcare facilities, and agri-food systems must be prioritised," she said.

The guidelines were developed in collaboration with international experts and underwent public consultation, receiving valuable feedback from stakeholders, including the pharmaceutical industry. Industry-led initiatives to tackle antibiotic pollution are already in place, though some areas may require updating to align with the new standards.

Targets to reduce AMR, protect ecosystems

The guidance establishes health-based targets to mitigate the risk of AMR spread and sets out measures to protect aquatic ecosystems affected by antibiotic contamination. These targets apply to all antibiotics, whether intended for human, animal, or plant use and cover the entire production process from the manufacturing of active pharmaceutical ingredients (APIs) to final packaging.

AMR arises when bacteria, viruses, fungi, and parasites develop resistance to medications, making treatments less effective. This results in more severe illness and an increased risk of untreatable infections. While AMR is primarily driven by the misuse and overuse of antimicrobials, millions worldwide still lack access to essential medications.