In its first guidance on antibiotic contamination in manufacturing, WHO noted that despite extensive documentation of high levels of antibiotic contamination, the issue remains largely unregulated. | File photo
According to the World Health Organization (WHO), the rise and spread of antimicrobial resistance (AMR) due to antibiotic contamination poses a significant threat to the global effectiveness of antibiotics. This includes antibiotics manufactured in locations responsible for the contamination itself.
In its first guidelines on antibiotic contamination in manufacturing, WHO noted that despite extensive documentation of high levels of antibiotic contamination, the issue remains largely unregulated. Furthermore, existing quality assurance standards often fail to address environmental emissions generated by the production process.
Guide to waste management in the manufacture of antibiotics
Ahead of the United Nations General Assembly (UNGA) high-level meeting on antimicrobial resistance scheduled for 26 September 2024, WHO guidelines point to a lack of public guidance on how consumers should dispose of unused or expired antibiotics, increasing the risk of inappropriate disposal and environmental contamination.
“Pharmaceutical waste from antibiotic manufacturing can lead to the development of drug-resistant bacteria, which can spread around the world and threaten public health,” said Dr Yukiko Nakatani, WHO Acting Assistant Director-General for Antimicrobial Resistance. She explained that controlling contamination from these sources is vital to keeping antibiotics effective for all.
According to the report, insufficient information is available globally on the environmental damage caused by pharmaceutical production. “This guidance provides an independent scientific basis for regulators, inspectors and industry to adopt strict controls on antibiotic contamination,” said Dr Maria Neira, Director of the WHO Department of Environment, Climate Change and Health.
Underlining the importance of transparency, Dr Neira stressed that the guidance would allow buyers and the public to consider manufacturers’ efforts to manage contamination when making decisions.
Global collaboration to combat antimicrobial resistance
The call for the guidelines to be adopted has been echoed by numerous international bodies, including the WHO Executive Board, G7 health ministers and the United Nations Environment Programme (UNEP). Jacqueline Alvarez, head of UNEP’s Division of Industry and Economics, stressed the importance of addressing the role of the environment in the spread of antimicrobial resistance. “Contamination prevention and control in manufacturing sites, municipal systems, health care facilities and agri-food systems must be prioritized,” she said.
The guidelines were developed in collaboration with international experts and subjected to a public consultation, which received valuable feedback from stakeholders, including the pharmaceutical industry. Industry-led initiatives to address antibiotic contamination are already underway, although some areas may need to be updated to align with the new standards.
Objectives to reduce AMR and protect ecosystems
The guidelines set health objectives to mitigate the risk of the spread of antimicrobial resistance and establish measures to protect aquatic ecosystems affected by antibiotic contamination. These objectives apply to all antibiotics, whether intended for human, animal or plant use, and cover the entire production process, from the manufacture of active pharmaceutical ingredients to final packaging.
Antimicrobial resistance occurs when bacteria, viruses, fungi and parasites develop resistance to medicines, making treatments less effective. This leads to more severe illness and a higher risk of untreatable infections. While antimicrobial resistance is primarily due to misuse and overuse of antimicrobials, millions of people around the world still lack access to essential medicines.
First published: September 5, 2024 | 15:49 IS
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