• The World Health Organisation (WHO) has published its first-ever guidance on antibiotic pollution from manufacturing. 

• Pharmaceutical waste from antibiotic manufacturing can facilitate the emergence of new drug-resistant bacteria, which can spread globally and threaten our health.

• The directive covers wastewater and solid waste management for manufacturing of antibiotics ahead of the United Nations General Assembly (UNGA) High-Level Meeting on antimicrobial resistance (AMR) taking place on September 26, 2024.

• 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.

• Antibiotic resistance leads to the loss of efficacy among available therapeutic options, in turn leading to increased morbidity, mortality and socioeconomic costs.

• The new guidance was developed in close collaboration with a diverse group of international experts, including representatives from academia, regulators, inspectors, international organizations, and other sectors.  

• It 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.

Environmental damage caused by manufacturing of medicines

• Antimicrobial drugs, including antibiotics, antifungals and antiparasitics, are used in human and veterinary medicine all over the world. They are used to treat and prevent diseases in humans and animals, and sometimes in food production to promote growth in healthy animals. Antimicrobial pesticides are also used in agriculture to treat and prevent diseases in plants.

• Antimicrobials given to humans, animals and plants are entering the environment and water sources (including drinking water sources) via wastewater, waste, run-off and sewage and through this spreading drug-resistant organisms and antimicrobial resistance.

• High levels of antibiotics in water bodies downstream of manufacturing sites have been widely documented. 

• Currently, antibiotic pollution from manufacturing is largely unregulated and quality assurance criteria typically do not address environmental emissions.

• Many experts have called for improved measures for management and disposal of antimicrobial-containing waste and runoff from manufacturing sites, farms, hospitals and other sources.

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

• The overall largest volume of active pharmaceutical ingredients (APIs) that reach the environment comes from waste carrying excreta from animals and humans treated with pharmaceuticals. However, the highest environmental concentrations found are the result of pollution from manufacturing.

• Pollution with antimicrobials is a special concern. In addition to direct ecological effects, environmental pollution with antimicrobials may also contribute to the development of resistance in both non-pathogenic and pathogenic microbes.

• The antibiotic residues in pharmaceutical manufacturing wastewater could exert sufficient selection pressures for the antibiotic resistance development with the ability to propagate and eventually spread worldwide. 

• Therefore, waste from manufacturing threatens the effectiveness and longevity of antibiotics as therapeutic agents in humans, livestock, and companion animals and crops.

• Additionally, consumers are not given sufficient information on how to dispose of unused antibiotics. For example, when the drugs have expired or when a course of antibiotics is finished, but some is still leftover.

What is antimicrobial resistance?

• Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial medicines. 

• As a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective and infections become difficult or impossible to treat, increasing the risk of disease spread, severe illness, disability and death.

• AMR is a natural process that happens over time through genetic changes in pathogens. Its emergence and spread is accelerated by human activity, mainly the misuse and overuse of antimicrobials to treat, prevent or control infections in humans, animals and plants.

• Micro-organisms that develop antimicrobial resistance are sometimes referred to as “superbugs”.

• AMR threatens the very core of modern medicine and the sustainability of an effective, global public health response to the enduring threat from infectious diseases. 

• It is estimated that bacterial AMR was directly responsible for 1.27 million global deaths in 2019 and contributed to 4.95 million deaths.