The ecotoxicity of medical pharmaceuticals – what needs to be done?
Clinicians are realising they need to think about and reduce the carbon footprint of the pharmaceuticals they use. In the UK 10-20% of all prescribed medicines are never used. Clinicians should be stopping any unnecessary prescribing, using the lowest effective dose for the shortest time, and using pharmaceuticals with the smallest carbon footprint.
Worrying only about carbon footprints and forgetting that we have a climate and an ecological crisis is called carbon tunnel vision. The other ecotoxicities of these pharmaceuticals are also important. The dangers come from their production, prescription, consumption collection, disposal and wastewater treatments. Forty percent of these medicines can end up in the sewage system. Active metabolites of these medicines are found almost everywhere in surface, ground and drinking water and can have environmental impacts.
The European Parliament in November 2021, adopted a resolution which calls on the European Commission to strengthen the sustainability of medicines and to respond to the demands made in the European Parliament’s 2020 resolution on a Strategic Approach to Pharmaceuticals in the Environment. The European Commission is set to propose revised legislation based on the Pharmaceutical Strategy for Europe in late 2022.
In response Health Care without Harm has made recommendations focused on three areas:
- Improving the transparency and sustainability of the pharmaceutical supply chain
- Strengthening environmental risk assessments for human medicine
- Encouraging greener medicines, promoting responsible use, and reducing pharmaceutical waste.
A shortened version of their 30 recommendations for greener medicines is
- Make it compulsory for pharmaceutical companies to publicly disclose their supply chain information.
- Include mandatory environmental criteria that address discharges of pharmaceutical residues into the environment.
- Develop environmental standards for drug production that will create a level playing field for drug manufacturers.
- Develop guidelines to help purchasing authorities use procurement policy to promote greener pharmaceuticals and sustainable production with clear environmental criteria and performance indicators.
- Advocate for a revision of the WHO Good Manufacturing process (GMP) framework that includes mandatory environmental criteria addressing the discharges of pharmaceutical residues into the environment.
- Strengthen international cooperation and dialogue with manufacturing countries, develop a global research agenda, and advocate for global solutions.
- Include environmental risks in the benefit-risk assessment for human medicines (already the case for veterinary medicines).
- Include environmental issues in the pharmacovigilance system to monitor real-world data and take into account the results of new scientific research.
- Establish a catch-up procedure for legacy drugs that have been authorised on the market before 1 December 2006.
- Make it compulsory for pharmaceutical companies to provide comprehensive and reliable environmental data at the time of marketing authorisation.
- Make Environmental Risk Assessments (ERA) data publicly accessible in an online database. This database should include all ecological and human toxicological data as well as the fate, behaviour, and ecotoxicological effect in the environment of medicines, their active ingredients, and their metabolites.
- Replace the current product-based environmental assessment system with a substance-based review system (‘monographs’), for which marketing authorisation holders would share responsibility, to reduce administrative burden, increase transparency, and reduce animal testing.
- Broaden the scope of ERAs to also address environmental risks during the production and formulation process, risks of antimicrobial resistance (AMR) development and maintenance in the environment from production, use, and disposal for antimicrobials, as well as environmental risks of degradation products, metabolites, and combinations effects,
- Require a regular review of ERAs to ensure that new environmental information available can be used in a timely manner.
- Ensure a better link between ERA data and other regulatory frameworks such as relevant water and soil legislation.
- Make pharmaceuticals that can cause a harm to the environment prescription-only, based on environmental risk thresholds.
- Support the training of healthcare professionals (in particular doctors and pharmacists) on the environmental impact of medicines and the exchange of best practice to promote responsible use and proper disposal.
- Incentivise the research and development of environmentally sustainable and climate-neutral pharmaceuticals throughout the value chain.
- Make pharmaceutical companies contribute to financing post-registration monitoring and water treatment costs due to pharmaceutical pollution, in line with the ‘polluter pays’ principle to improve their responsibility for the pollution they generate.
- Develop guidance for healthcare institutions to reduce the discharges of pharmaceutical residues from use and disposal to municipal wastewater.
- Promote the separate collection of urine of patients administered with X-ray or magnetic resonance imaging (MRI) contrast agents.
- Make it compulsory for pharmaceutical companies to measure and consistently report (both in terms of comparability and quality) the greenhouse gas emissions of their products throughout the value chain.
- Ban advertising for OTC medicines that can pose a risk to the environment.
- Adopt stronger market conditions for medicines with high environmental risk.
- Classify pharmaceutical substances based on environmental criteria and create a label for OTC products that meet high environmental standards to reward and incentivise green production and development as well as to allow patients to make informed purchasing decisions.
- Develop implementation guidelines on pharmaceutical collection schemes that harmonise take-back systems.
- Make it compulsory to feature disposal information for patients on the outer drug packaging and in pharmacies (in addition to patient information leaflets) to prevent disposal via the toilet or sink.
- Compel pharmaceutical companies to propose different packaging sizes and forms for their products, in particular for liquid drugs, to reduce the amount of pharmaceutical waste.
- Compel pharmaceutical companies to contribute to financing pharmaceutical collection schemes.
- Regulate the management of human medicinal waste beyond cytostatic and cytotoxic substances.
Not all these recommendations would be welcomed by busy clinicians. Making pharmaceuticals that can cause a harm to the environment prescription-only, and adding extra training on the environmental impact of medicines for doctors and pharmacists may add to their work without improving care.
The NHS England and NHS Improvement Board has a carbon plan and at its meeting in September 2021 set out its net zero supply chain roadmap so that by 2030, the NHS would no longer purchase from suppliers that are not aligned with this ambition, and by 2045, the NHS aims to reduce the emissions of the NHS supply chain to net zero. Beyond the recommendation on transparency of greenhouse gas emissions for all of the supply chain the NHSE has not set interventions on the other environmental impacts. They are starting to look at medicines more broadly across the supply chain and there are a few that they may be looking at in the coming months (e.g. packaging).
These UK and EU initiatives show that we need a robust process of procurement with an environmental rating of pharmaceuticals so that clinicians can prescribe them safely knowing that the pharmaceuticals available for patients have both a low carbon footprint, and a low ecotoxic impact.
Terry Kemple is an elected member of the Executive Committee for UK Health Alliance on Climate Change