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The World Health Organization (WHO) has released a global guidance on wastewater and solid waste management for manufacturing of antibiotics.

A move many have called “timely.”

There are several factors that may lead to antimicrobial resistance (AMR), central of which is the irrational use of antimicrobial agents; another is pollution occasioned by antibiotic manufacturing.

Pharmaceutical waste from antibiotic manufacturing has been identified by experts as a major environmental problem, as it creates conditions under which bacteria can develop resistance against this key class of medicines.

According to the WHO, AMR contributed to 4.95 million deaths in 2019 while being the direct cause of an estimated 1.27 million global fatalities.

These figures demonstrate why many have referred to AMR as a silent pandemic and international organizations such as the WHO have classified it among the top “public health and development threats.”

As it stands, pollution due to antibiotics, particularly manufacturing, is an aspect that, for the most part, remains unregulated. Additionally, environmental emissions remain unaddressed in quality assurance protocols.

This is why key stakeholders came together to develop this guidance.

 

Purpose of the guidance

One of the goals of this document is to give binding instruments such as policies, regulations and laws a solid scientific foundation on which to include relevant targets in order to stop the emergence and spread of antimicrobial resistance.

With the guidance document, pharmaceutical manufacturing companies are able to create, implement and report risk management plans that ensure these targets are progressively met while remaining accountable to the public.

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What is in the document?

It includes targets for ecotoxicological dangers to aquatic life caused by all antibiotics intended for use in humans, animals, or plants, as well as targets based on human health to lower the risk of antibiotic resistance emerging and spreading.

In addition, it also covers every stage of the process, from the production of active pharmaceutical ingredients (APIs) and formulation to the primary packaging of completed goods.

Both liquid and solid waste are covered by the guidance, with an emphasis on discharges to land, runoff, and liquid effluent.

Risks for antibiotic-induced resistance selection both before and after dilution in recipient water bodies are assessed, as is the potential for resistant microorganisms to be released.

Manufacturing plants that produce more than one API or final product require separate assessments.

Best practices for risk management, such as public transparency and internal and external auditing, are also included in this guidance.

Crucially, this guideline recognizes the need to safeguard and strengthen the global supply and to guarantee adequate, affordable, and equitable access to quality-assured antibiotics. It also involves incremental adoption and stepwise improvement as necessary.

 

Bigger picture

According to the WHO, numerous international organizations, plans, and reports have called for the release of this new guidance aiming to have a significant impact against AMR.

Including the AMR Global Leaders Group call to action, the G7 Health Ministers Meeting communiqué, the United Nations Environment Programme report, the World Health Assembly resolutions that resulted in the Global Action Plan to tackle antimicrobial resistance and many more.

The guidance is targeted for national regulatory agencies responsible for the regulation of medical product manufacturing or wastewater and solid waste.

It also targets procurement agencies of antibiotics for human, animal and plant use; entities responsible for generic substitution schemes and reimbursement decisions; third-party audit and inspection bodies; industrial actors in all stages of the antibiotic production chain; investors in the sector; and waste and wastewater management services that handle antibiotic wastes.

Find the full document here.

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