Executive Summary

About 2 000 active pharmaceutical ingredients (APIs) are being administered worldwide in prescription medicines, non-prescription drugs and veterinary drugs, the residues of which are of increasing environmental concern as the number and density of humans and livestock requiring healthcare escalates.

Active pharmaceutical ingredients are found in surface waters, groundwater, drinking water, soil, manure, biota, sediment and the food chain. Although the contribution of each emission source varies across regions and types, the dominant sources of pharmaceuticals in the environment stem from untreated household wastewater and effluent from municipal wastewater treatment plants. Emissions from manufacturing plants and intensive agriculture and aquaculture can be important pollution hotspots locally.

Because pharmaceuticals are intentionally designed to interact with living organisms at low doses, even low concentrations in the environment can have unintended, negative impacts on freshwater ecosystems. For example, active substances in oral contraceptives have caused the feminisation of fish and amphibians; psychiatric drugs, such as fluoxetine, alter fish behaviour making them less risk-averse and vulnerable to predators; and the over-use and discharge of antibiotics to water bodies exacerbates the problem of antimicrobial resistance – declared by the World Health Organisation as an urgent, global health crisis that is projected to cause more deaths globally than cancer by 2050.

Advances in monitoring can help close the knowledge gap and support policy responses

Most OECD countries have established watch-lists and voluntary monitoring programmes for certain pharmaceuticals in surface water, but the majority of APIs, metabolites and transformation products remain unmonitored and without ecotoxicity data. There are therefore a number of uncertainties associated with the environmental risk assessment of pharmaceuticals due to lack of knowledge concerning their fate in the environment and impact on ecosystems and human health, and the effects of mixtures of pharmaceuticals and other chemicals.

The cost of monitoring, limited data for policy development and an absence of a systematic approach to risk assessment were three barriers to taking action identified by governments in the 2017 OECD Questionnaire on Contaminants of Emerging Concern in Freshwaters. Advances in monitoring technologies and modelling can help close the knowledge gap and support policy responses. Real-time in-situ monitoring, passive sampling, biomonitoring, effects-based monitoring, non-target screening, hotspots monitoring, surrogate data methods, early-warning systems and holistic modelling can help identify and prioritise APIs in the environment, and anticipate sources of contamination. Country and international initiatives are crucial to improve the knowledge base and exchange of data, methodologies and technologies to address risks between countries and sectors.

Moving towards proactive policy action to curb pharmaceutical pollution

Current policy approaches to manage pharmaceutical residues are inadequate for the protection of water quality and freshwater ecosystems upon which healthy lives depend. They are often reactive (i.e. when risks are proven), substance-by-substance (i.e. individual environmental quality standards) and resource intensive. And diffuse pollution, particularly from livestock and aquaculture, remains largely unmonitored and unregulated.

All stakeholders along the pharmaceutical chain have a critical role to play in the transition to more effective management of pharmaceutical pollution. Voluntary participation alone will not deliver; economic and regulatory drivers from central government are needed.

Policy-makers will need to factor in financing measures for the upgrade, operating and maintenance costs of wastewater treatment plants, as well as policy transaction costs to facilitate the transition from reactive to proactive control of pharmaceutical residues in water bodies. The relative risk of pharmaceuticals should also be compared with other water 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.

While acknowledging the critical role of pharmaceuticals for human and animal health, a combination of the following four, proactive strategies can cost-effectively manage pharmaceuticals in the environment. Their effectiveness however, depends on collaboration across several policy sectors and the adoption of the life cycle approach; taking action through pharmaceutical design, authorisation, manufacturing, prescription, over-the-counter purchases, consumer use (patients and farmers), collection and disposal, and wastewater treatment. A focus on preventive options early in a pharmaceutical’s life cycle, may deliver the most long-term and large-scale environmental benefits.

1. 1. Improve monitoring and reporting on the occurrence, fate, toxicity, and human health and ecological risks of pharmaceutical residues in order to lay the ground for pollution reduction policies. Consider the inclusion of environmental risks in the risk-benefit analysis of authorisation of new pharmaceuticals, and risk intervention and mitigation approaches for pharmaceuticals with high environmental risk.

2. 2. Implement source-directed approaches, such as the sustainable design and procurement of pharmaceuticals, to prevent the release of pharmaceutical residues into water bodies.

3. 3. Introduce use-orientated approaches, such as disease-prevention, improved diagnostics and restrictions on pharmaceuticals with high environmental risk, to reduce inappropriate and excessive consumption of pharmaceuticals.

4. 4. Implement end-of-pipe measures, such as advanced wastewater treatment, public collection schemes for unused pharmaceuticals, and education campaigns, to safely dispose and remove pharmaceutical residues.

Executive Summary