Pharmaceutical Residues in Freshwater

OECD Policy Recommendations on addressing pharmaceutical residues in freshwater

The OECD recommends government’s take a collective, life cycle approach to managing pharmaceuticals in the environment. This means: i) designing and implementing a policy mix of source-directed, use-orientated and end-of pipe measures; ii) targeting stakeholders throughout the life cycle of pharmaceuticals; and iii) using a combination of voluntary, economic and regulatory instruments. A national pharmaceutical strategy and action plan to manage environmental risks should be developed in collaboration with relevant government departments, local authorities and other stakeholders, and be supported by a strategic financing strategy to ensure effective implementation.

Cross-cutting recommendations

• Identify potential environmental risks of existing and new active pharmaceutical ingredients (APIs) through intelligent and targeted monitoring and assessment strategies. Reduce unknowns on relationships between pharmaceuticals, and human and environmental health. The relative risk of APIs should also be compared with other pollutants (e.g. heavy metals, persistent organic pollutants and other contaminants of emerging concern) to achieve improvements in water quality and ecosystems in the most cost effective way.

• Encourage the uptake of new monitoring methods (see sections 2.4 and 2.5), modelling and decision-support tools to better understand and predict the risks, including mixtures as drivers of risk. Prioritise APIs and water bodies of highest concern.

• Increase access to data and information, and institutional coordination, to reduce knowledge gaps (see section 4.3.3).

• Adopt precautionary measures when scientific evidence is uncertain, and when the possible consequences of not acting are high.

• Factor in financing needs and measures to recover policy transactions costs, and factor in the capacity of government officials and stakeholders to implement policies.

• Educate and engage with the public to manage perceived and actual risks, and improve awareness and understanding.

Source-directed recommendations. Pharmaceutical life cycle stages: design, marketing authorisation, manufacturing, post-authorisation

• Develop clear and shared environmental criteria (and performance indicators) for sustainable ‘green’ procurement of pharmaceuticals.

• Consider expansion of the regulatory framework for good manufacturing practice to include mandatory environmental criteria.

• Develop drinking water safety plans, monitoring programmes of pharmaceuticals and incidence reporting to identify and prevent contamination and adapt policy to new science.

• Ensure Environmental Risk Assessment (ERA) robustness, consistency and transparency (see section 4.3.1). Establish a centralised database with independent regulatory oversight to share ERAs of APIs and prevent duplication efforts.

• Consider environmental risks in risk-benefit authorisation of human pharmaceuticals in order to manage and mitigate risks. Place more stringent conditions for putting a pharmaceutical on the market that is of high-risk to the environment (e.g. increased risk intervention and mitigation options, prescription only, eco-labelling, post-approval monitoring).

• Provide incentive structures to advance green and sustainable pharmacy (see section 4.3.2). A return on public investments in new pharmaceuticals should be considered when assessing support for the private sector in pharmaceutical development.

• Establish new business models for pharmaceuticals that balance access needs, appropriate use and adequate return. This is particularly important for new antibiotics and tackling antimicrobial resistance; current business models link profit (sales) with volume (consumption).

Use-orientated recommendations. Pharmaceutical life cycle stages: Prescription and use

• Reduce the incidence of infection and disease. Improved access to safe water supply, sanitation and hygiene is particularly important. Other important measures include improved stable and livestock handling, practitioner training, education campaigns and vaccinations.

• Reduce unnecessary use and release of pharmaceuticals. Improve diagnostics and delay prescription of pharmaceuticals when they are not immediately required. If not already in place, consider bans or restrictions on antibiotics for preventative use, and hormones as growth promoters, in the livestock and aquaculture sectors.

• Optimise the use of pharmaceuticals with effective diagnosis, dosing, personalised medicines and targeted delivery systems.

• Reduce self-prescription of pharmaceuticals with high environmental risk (e.g. antibiotics and pharmaceuticals that target the endocrine system) and illegal sales of pharmaceuticals.

• Promote best practices on the storage and use of livestock manure and slurry from livestock treated with pharmaceuticals.

End-of-pipe recommendations. Pharmaceutical life cycle stages: collection and disposal, and wastewater treatment and reuse

• End of pipe measures should only be used in complementary to source-directed and use-orientated measures. An over-emphasis on upgrading of wastewater treatment plant (WWTP) infrastructure is not a sustainable, optimal use of limited resources.

• Ensure value-for-money in investments in WWTP upgrades through evaluation and prioritisation, including achieving economies of scale (see section 3.5.1). Consider potential trade-offs (e.g. incomplete removal of APIs to varying degrees; generation of potentially toxic transformation products and sludge; increased energy, chemicals and carbon emissions).

• Factor in financing needs and cost-recovery mechanisms for capital and operation and maintenance costs of WWTP upgrades, including potential affordability issues with sanitation tariffs.

• Ensure appropriate collection and disposal of waste pharmaceuticals. Educate and engage with health professionals, veterinarians, consumers and farmers to raise awareness about inappropriate disposal of unused medications. Consider extended producer responsibility schemes to recover costs.

• Promote best practices on the use and disposal of biosolids (which may include toxic transformation products).