On Thursday 14 November, Hannah Leckie and Bob Diderich (OECD Environment Directorate) presented the key findings of the report "Pharmaceutical Residues in Freshwater: Hazards and Policy Responses", which warns of the risks from increased pharmaceutical residues in the environment, and how policy makers and other stakeholders can take action to reduce the risks.
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Green Talks LIVE webinar: Pharmaceutical Residues in Freshwater
1. Pharmaceutical Residues in Freshwater
Hazards and Policy Responses
Hannah Leckie
OECD Environment Directorate
OECD Green Talks : LIVE
14 November 2019
Paris, France
#GreenTalks @OECD_ENV
2. • Sources and pathways of
pharmaceuticals in the environment
• Why should we be concerned?
• Current policy responses
• Barriers to action
• Selected policy recommendations and
country examples
Outline
4. Pharmaceutical residues in water:
A global challenge
Source: aus der Beek, T. et al. (2016), “Pharmaceuticals in the environment: Global occurrences and perspectives”,
Environmental Toxicology and Chemistry, Vol. 35/4, pp. 823-835.
Number of pharmaceuticals detected in
surface water, groundwater, tap water and/or drinking water
5. • Increasing pharmaceutical usage with:
– Ageing population
– Increased life-spans
– Economic growth
– Engineering of new pharmaceuticals
– Clinical practices evolve – incl. recommendations
of earlier treatment, higher dosages or prolonged
treatment
– Livestock and aquaculture intensification
– Climate change
The use of pharmaceuticals is growing
6. Climate change exacerbates the impact
of pathogens
Source:Cavicchiolietal.(2019),Scientists’warningtohumanity:
microorganismsandclimatechange,NatureReviewsMicrobiology
7. Example: Pharmaceutical usage forecast
to increase substantially in Germany
Source: Civity (2017), Pharmaceutical usage in the context of demographic change: The significance of growing
medication consumption in Germany for raw water resources, Civity Management Consultants.
9. Current policy approaches
Current approaches
• Reactive
• Substance-by-substance, resource intensive
• Focus on:
• monitoring
• end-of-pipe measures
Problems with current approaches
• Large and growing number of pharmaceuticals, and
knowledge gaps (e.g. long-term effects, mixture & additive
effects, metabolites and transformation products)
• Wastewater treatment plant upgrades limited by removal
efficiencies + costly and high energy/carbon footprint
10. • Cost and lack of available resources
• Knowledge-related barriers
– Lack of robust evidence / poor understanding
– Lack of systematic approach for risk assessment
• Legislative barriers
– Lack of framework to develop legislation
– Legislation not flexible
– Lack of control of internet purchases
– Boundaries to apply the Precautionary Principle
• Reluctance to apply the Precautionary and
Polluter Pays Principles
• Resistance from industry
OECD questionnaire:
Barriers to action
12. Selected policy recommendations
A combination of:
• Occurrence, toxicity and impacts of pharmaceuticals in the environment - in order to lay
the ground for future policy
• Assess relative risk of pharmaceuticals in the environment in comparison to other
contaminants in water
Improvement in knowledge, understanding and reporting
• Consider environmental risks in risk-benefit analysis for pharmaceutical authorisation
• Prioritise substances and water bodies of highest concern
• Incentivise green pharmacy or personalised medicines
• Green public procurement with environmental criteria to limit pollution
Source-directed measures
• Promote sustainable use (e.g. restrictions on harmful pharmaceuticals, improved
diagnostics, livestock vaccinations, education campaigns, eco-labelling)
Use-orientated measures
• Upgrade WWTPs if necessary
• Public take-back schemes of unused drugs
End-of-pipe measures
14. Policy approaches to tackle AMR save
lives…
Source: OECD (2018). Stemming the Superbug Tide: just a few dollars more. 2018. oe.cd/amr-2018
15. …and are a very good investment for
OECD and EU countries
Source: OECD (2018). Stemming the Superbug Tide: just a few dollars more. 2018. oe.cd/amr-2018
18. Green Talks LIVE
Up next…
22 Nov - Scaling up climate-compatible infrastructure -
Insights from national development banks in Brazil and
South Africa
For more information: http://oe.cd/GreenTalks
18
Thank you for joining us
#GreenTalks @OECD_ENV
Editor's Notes
Thanks very much Bob and good evening everybody – both to those here in the flesh and to those online – it is great to have you here.
This talk conveys the key messages of a project on pharmaceuticals in water that was triggered by an emerging and growing concern of water pollution from our OECD member countries, and their demand for policy guidance on how to implement more economically-efficient and environmentally-effective policies to improve water quality. The report showcases a number of case studies submitted by country delegates and experts, and builds on discussions held at an OECD workshop last year – all of which I am most grateful for.
This afternoon I will briefly go through some of the main messages of this report, including:
Sources of pharmaceuticals in the environment
Why should we be concerned about pharmaceutical residues in the environment?
Current policy responses in OECD countries and demands on policy solutions
Barriers to taking policy action
Some of the key policy recommendations, including specific recommendations on AMR, and their cost-effectiveness.
This diagram illustrates the sources of pharmaceuticals in the environment – where they can end up in surface water, groundwater or soil.
Major sources of pollution include:
Pharmaceutical manufacturers
Households, hospitals and elderly care homes via WWTPs and inappropriate disposal of pharmaceuticals. The direct discharge of untreated wastewater can also be a major source of PIE, particularly in developing economies where wastewater collection and treatment facilities may not yet be established
Agriculture and aquaculture, which can involve the use of antibiotics and hormones as growth promoters and for prevention of disease.
It is estimated that 30-90% of the oral pharmaceuticals administered to humans and animals are excreted as active substances, which find their way into our sewer systems and into the water cycle. Residues of pharmaceuticals have been detected in surface water and groundwater across the globe, as this map shows. However, there is still a lot we don’t know about the occurrence of pharmaceuticals in the environment – areas shaded in grey show where there is no data. And we know even less about the concentrations of pharmaceuticals in the environment. Recent research by Prof. Alistair Boxall shows concentrations of antibiotics in some cities in Africa, Asia and S. America in the 100mg/L range, which is a key concern for antimicrobial resistance. In OECD economies, the highest concentrations are found in areas with high population density and low river flows for dilution of wastewater discharge.
The use of pharmaceuticals in increasing with:
Ageing populations; Increased life-spans;
Economic growth, particularly in emerging economies (and with it, an increasing ability and expectation to treat ageing-related and chronic diseases)
Constant engineering of new pharmaceuticals;
clinical practices evolve – including recommendations of earlier treatment, higher dosages or prolonged treatment
Intensification of livestock and aquaculture practices.
Lastly, climate change will exacerbate existing diseases and increase the need for pharmaceuticals.
Anthropogenic climate change stresses native life, thereby enabling pathogens to increasingly cause disease. Human activities, such as population growth and transport, combined with climate change increase antibiotic resistance of pathogens and the spread of waterborne and vector-borne pathogens, thereby increasing diseases of humans, other animals and plants, and therefore the need for greater use of pharmaceuticals.
CC will also lead to an increase the variability of rainfall and river flows effecting the dilution potential of pharmaceutical residues in water.
As a result of these factors, unless adequate measures are taken to manage the related risks, pharmaceuticals will increasingly be released into the environment.
For example, Germany has forecasted that the total usage of prescription pharmaceuticals will increase by up to nearly 70% by 2045.
And self-medication with OTC medicines is estimated to grow even faster.
All of these trends point to more pharmaceuticals in the environment, unless action is taken.
Newspaper headlines reflect increasing detection of pharmaceuticals in the environment, increasing public awareness of the potential impacts, and expectations for improved drinking water quality and projection of freshwater ecosystems. I think the media do a pretty good job of reporting the science.
For example, recent headlines read:
Large numbers of pharmaceuticals in rivers at level dangerous to wildlife and the environment. [SLIDE]
Pollution puts pharmaceutical supply chains under the spotlight [SLIDE]
Why are these male fish growing eggs?: Hormones and other pharmaceuticals act as endocrine disruptors which can cause the feminisation of fish [SLIDE]
Anti-depressants are finding their way into fish brains and altering their behaviour; [SLIDE]
Cattle drug threatens thousands of vultures’[SLIDE]
World's rivers 'awash with dangerous levels of antibiotics‘. Largest global study finds the drugs in two-thirds of test sites in 72 countries [SLIDE]
Pharmaceutical pollution is linked to rise in superbugs; [SLIDE]
WHO warns urgent action is needed to tackle global misuse of antibiotics; [SLIDE]
And OECD figures show antibiotic resistant superbugs could kill 90,000 Britons by 2050 and could kill 1.3 million in Europe, unless more is done to tackle the issue. The projected rise in resistance to second- and third-line antibiotics is particularly worrisome.
More documentation laboratory tests on of the effects of pharmaceutical residues in aquatic organisms is documented in the report.
Current policy approaches to water quality protection are typically reactive; measures are adopted only when routine monitoring is in place and risks can be proven.
We have found that country responses to the pharmaceutical problem have often focussed on monitoring (although the vast majority of them remain unmonitored) and end-of pipe measures, such as upgrading of wastewater treatment plants. Switzerland is an example where major WWTPs have been upgraded to remove pharmaceutical residues and other emerging pollutants.
But there are two problems with these approaches:
There are a number of problems with this approach:
Firstly, the large number of pharmaceuticals and the constant engineering of new ones means it will be impractical (technically and economically) to undertake analytical monitoring and environmental risk assessment en masse for all active pharmaceutical ingredients in the environment. There are about 2000 pharmaceutical ingredients being used worldwide, and we only have comprehensive environmental toxicity data for about 10% of them.
Secondly, wastewater treatment plant upgrades are limited by their removal efficiencies, high investment and operation costs (and therefore affordability issues), and increased energy consumption and carbon emissions. They also do not remove diffuse or non-point source pollution of pharmaceuticals used in agriculture and aquaculture.
As part of this project, the OECD conducted a Questionnaire on Contaminants of Emerging Concern, including pharmaceuticals, in Freshwater. A number of barriers to action were identified by governments, including:
The high costs involved and limited resources. [SLIDE]
Knowledge-related barriers, such as insufficient evidence and an absence of a systematic approach for risk assessment. [SLIDE]
Legislative barriers, including a lack of: frameworks to develop legislation, flexibility of legislation, and control over internet purchases. [SLIDE]
Regulatory boundaries to apply the precautionary and the polluter pays principles. [SLIDE]
Resistance from industry
It is important to qualify that pharmaceuticals are necessary for human and animal health, food production and economic welfare. We are not trying to reduce access to pharmaceuticals.
This being said, we recommend a life-cycle approach to addressing pharmaceuticals in the environment, with action from all stakeholders from design to disposal.
An efficient abatement strategy combines policy options at various stages of the pharmaceutical life cycle, involving all stakeholders, including government agencies (involving environmental and health policy and marketing authorisation), pharmaceutical companies and manufacturers, distributors, physicians, veterinarians, pharmacists, hospitals, individual users (both patients and farmers), and wastewater treatment utilities.
Action on pharmaceuticals in the environment is much more likely to be extended and sustainable if it is mainstreamed into broader health, agriculture and environment policy.
The life-cycle approach means using a combination of 4 approaches:
1. One. Improvement in the knowledge, understanding and reporting on the occurrence, toxicity and impacts of pharmaceuticals in the environment in order to lay the ground for future policy. For example, Korea uses suspect and non-target screening to identify and prioritise pharmaceuticals for water quality monitoring. The transparency of data and ERA of pharmaceutical ingredients should also be improved, to reduce duplication of costly testing efforts. The relative risk of pharmaceuticals in the environment need to also be compared with other more traditional pollutants – such as heavy metals and persistent organic pollutants – to direct limit resources to achieve improvements in water quality and ecosystems in the most cost-effective way.
Two. Source-directed policies to prevent the release of pharmaceuticals into water bodies. This may include incentives for the design green pharmacy or personalised medicines, incorporation of environmental risks into pharmaceutical authorisation, and green public procurement with environmental criteria to limit pollution. It also means prioritising substances and water bodies of highest concern, and targeting areas of high pollution. This may include regulations as part of good manufacturing processes for pharmaceutical manufacturing plants, as part of industry audits or wastewater discharge permits.
Three. Use-orientated polices to reduce inappropriate or excessive consumption of pharmaceuticals. For example, Germany has developed an environmental checklist for veterinarians and farmers with the aim of reducing the use and release of veterinary pharmaceuticals to the environment. Improved health, wellbeing and hygiene practices, and improved diagnostics can also reduce unnecessary use of pharmaceuticals.
Four. End-of-pipe measures such as improved waste and wastewater collection and treatment to remove pharmaceutical residues after their use. For example, Australia has a national pharmaceutical collection and disposal programme, with retail pharmacies commonly acting as collection sites, to avoid improper disposal of used and expired medications. Emission-reduction through WWTP upgrades – albeit costly - may be a necessary end-of-pipe measure in view of the high and growing demand for pharmaceuticals by society. They should be complimentary to source and use-orientated measures, and be site selection for WWTP upgrades based on size of the population served, sensitivity of the receiving ecosystem
A focus on preventive source-directed and use-orientated options early in the pharmaceutical life cycle, may deliver the most long-term, cost-effective and large-scale benefits.
Other examples:
In the United Kingdom, the poultry industry has successfully reduced unnecessary antibiotic use – whilst increasing meat production – with a voluntary antibiotic stewardship programme.
Sweden has a ‘Wise List’ of recommended pharmaceuticals for the treatment of common diseases that takes into account and environmental impact when comparing medications that are equally safe and equally suitable for the medical purpose. NHS Scotland has replaced diclofenac with naproxen as the preferred prescription choice of anti-inflammatory, for environmental reasons.
The Swedish government has also just introduced a revised public procurement system in which environmental criteria is considered when pharmaceutical companies complete to obtain product subsidies for state healthcare. Norway, the Netherlands and Demark are also considering sustainable procurement criteria for pharmaceuticals
The United States has national regulations on the disposal of hazardous pharmaceutical waste in the health sector.
Switzerland has a nationwide tax to fund the upgrade of 100 wastewater treatment plants with new technologies to reduce pharmaceuticals in water bodies.
France, Germany, the Netherlands, Sweden and the United Kingdom have all started multi-sector dialogues to tackle the problem. At the EU level, a “Strategic Approach to Pharmaceuticals in the Environment” identifies actions for stakeholders throughout the pharmaceutical life cycle with an emphasis on sharing good practices, on cooperating at international level, and on improving understanding of the risks.
Policy approaches to tackle AMR save lives… For example, OECD modelling shows improved hand hygiene, stewardship prgrammes such as educational and behavioural interventions for physicians and decision aid tools, and enhanced environmental hygiene and advanced cleaning techniques in hospitals could each avoid 20,000 deaths from AMR each year in the EU and the European Economic Area.
Public health interventions to tackle AMR are a cost-effective (and very often cost-saving) investment in OECD and EU countries
Improved hand hygiene, stewardship programmes and delayed prescriptions are (usually) cost-saving.
Environmental hygiene, rapid diagnostic testing are often cost-saving – but large differences across countries
Mass media campaigns are sometimes (e.g. in G7 countries) cost-savings
CE = cost-effectiveness ratio
Combining interventions in a 4-pronged public health package provides the best results to Stem the Superbug Tide: up to 47,000 lives saved per year in the OECD and EU alone. And decreasing healthcare expenditure by an average of 3 USD/Capita/Year, and up to 10USD/capita/yr in Malta.
If you would like further information, you can download the full report or the policy highlights from our website.
Thank you very much for listening in. Questions are welcome.