NHS Highland, the University of the Highlands and Islands – Environmental Research Institute (UHI-ERI), and the University of Nottingham won a £100,000 UKRI Medical Research Council (MRC) grant, working in partnership with the James Hutton Institute, Scottish Water, the Scottish Environment Protection Agency, and the University of Uppsala.
The project seeks to develop and evaluate, for the first time in the UK, an eco-directed prescription framework that incorporates environmental sustainability alongside clinical and cost effectiveness. This proposes that if pharmaceuticals are of comparable medical efficacy, safety, and effectiveness, then the environmental impact around pollution in the aquatic environment (e.g., drug ecotoxicity, predominance towards AMR) should be considered during the formulary process to better inform prescribers, enabling them to make more sustainable prescribing choices. This is an innovation first in the UK – and a first step towards improvement of medicine prescribing in Scotland to reduce pharmaceutical pollution.
The 12-month project will be delivered through a truly trans-disciplinary and cross-sectoral approach integrating public health, prescribing, environmental science, and social science methods and data. Briefly, this will include desk-based analysis of pre-existing data, stakeholder engagement, and prescriber and patient focus group activities. Qualitative and quantitative data will be incorporated into a probabilistic graphical model to create the formulary framework.
The investigators have strong track-records and expertise in pharmaceutical public health, formulary development, qualitative health services research, and analysis of the environmental occurrence and impact of emerging contaminants. This work will capitalise on the established networks and resources of national and international partners representing key stakeholders across the healthcare, prescribing, pharmaceutical industry, environment, and water sectors, including through the One Health Breakthrough Partnership. Project partners (from the James Hutton Institute, University of Uppsala, Scottish Water, and SEPA) will provide valuable contributions in their individual remits to enable delivery of the project, and wider stakeholders will be invited to engage with this project through the Project Stakeholder Group.
Overall, this project seeks to facilitate new knowledge sharing across organisational boundaries, raise awareness of the environmental impact of medicines, and develop novel and robust solutions to complex sustainability issues. It is a first step towards improvement of medicine prescribing in Scotland to reduce pollution, and aims to benefit the NHS, prescribers, and patients through enabling better informed and more sustainable prescribing choices.
NHS Highland, the University of the Highlands and Islands – Environmental Research Institute (UHI-ERI), and the University of Nottingham were awarded a UKRI-MRC grant to develop a framework for an eco-directed formulary that will incorporate environmental data on medicines into the prescribing process, alongside clinical and cost effectiveness.
This research seeks to generate new knowledge and awareness of the environmental impact of medicines, and develop novel and robust solutions to complex sustainability issues. It is a first step towards improvement of medicine prescribing in Scotland to reduce pharmaceutical pollution.
Who is involved?
The research investigators (from NHS Highland, UHI-ERI, and the University of Nottingham) are experts in pharmaceutical public health, formulary development, qualitative health services research, environmental science, and eco-toxicology. Project partners include the James Hutton Institute, University of Uppsala, Scottish Water, and the Scottish Environment Protection Agency (SEPA). The project partners will provide valuable contributions including technical expertise in environmental modelling, analysis of environmental data and risk assessment of pharmaceuticals, and policy and regulatory guidance (see details below).
The project will maximise on established networks, and engage with various stakeholders across the healthcare, prescribing, pharmaceutical industry, environment, and water sectors to form the Project Stakeholder Group. This will include networks of the One Health Breakthrough Partnership – a globally unique, cross-sector group committed to addressing pharmaceutical pollution in the environment.
Who is the research team?
- Prof Sharon Pfleger (PI, NHS Highland) – Sharon is a Consultant in Pharmaceutical Public Health, bringing expertise in pharmaceutical use at a population level, formulary development at local and national level, and public health knowledge, with strong connections across the UK and internationally. She is co-founder of the OHBP and was expert advisor to the Royal Pharmaceutical Society for development of its sustainability policies, and currently sits on the Scottish Government’s Climate Change and Sustainability Board for delivery of NHS Scotland’s sustainability strategy.
- Prof Claire Anderson (Co-I, University of Nottingham) – Claire is a leading social pharmacy and qualitative health services researcher, bringing expertise in operation and analysis of focus groups and consensus methodologies. She is President of the Royal Pharmaceutical Society (RPS) bringing strong networks to the project for dissemination and stakeholder engagement. The RPS has developed its sustainability policy during her presidency, which includes a call for improvement of medicine prescribing and use.
- Dr Naoko Arakawa (Co-I, University of Nottingham) – Naoko is an assistant professor in international pharmacy and experienced researcher using consensus development methods to develop and evaluate needs-based pharmacy practice. She holds a Global Lead for Competency Development in the International Pharmaceutical Federation (FIP) and is a Secretary of Academic Pharmacy Section of the FIP.
- Prof Stuart Gibb (Co-I, UHI-ERI) – Stuart is is UHI’s leading Professor in Environmental Sciences, Chair of UHI’s WaterHub KE Sector Group, and co-founder of the OHBP. He brings expertise in environmental science and sustainability, strong networks and cross-sector KE experience.
- Dr Mark Taggart (Co-I, UHI-ERI) – Mark is an environmental analytical chemist and ecotoxicologist with 30 years of experience. He brings a strong background and expertise in environmental contamination and ecotoxicology (contaminant pathways/ uptake/ effects in organisms).
- Dr Lydia Niemi (RCo-I, UHI-ERI) – Lydia is an environmental analytical chemist with experience in environmental monitoring, analysis, and risk assessment of pharmaceuticals, and cross-sector stakeholder project management for project delivery. She is the project co-ordinator.
Who are the project partners?
- The James Hutton Institute will provide technical expertise in modelling and environmental science to develop the formulary framework through a multi-criteria decision support tool (Bayesian Belief Network modelling), and participation in the Project Stakeholder Group to support cross-sector engagement and dissemination.
- Scottish Water will provide scientific and wastewater regulatory guidance and data access, and participate in the Project Stakeholder Group to support cross-sector engagement and dissemination. Match funding for the RCo-I’s salary was provided by Scottish Water.
- SEPA will provide scientific, policy and regulatory context/guidance and data access (particularly through its novel data visualisation tool of pharmaceutical pollution in the water environment, see below). SEPA will participate in the Project Stakeholder Group to support cross-sector engagement and dissemination.
- The University of Uppsala will provide technical expertise in pharmacoepidemiology and environmental impact of pharmaceuticals, and data/information on the Stockholm Wise List to support development of the formulary framework. Partners will also participate in the Project Stakeholder Group to support cross-sector engagement with European groups and dissemination.
How will the research be carried out?
This research will be delivered through a trans-disciplinary approach integrating public health, prescribing, environmental science, and social science methods and data. This will include desk-based analysis of pre-existing data, stakeholder engagement, and prescriber and patient focus group activities. Qualitative and quantitative data will be incorporated into a probabilistic graphical model to create the formulary framework.
What are the specific aims?
The research team (with project partners, and feed in from the Project Stakeholder Group) will:
- Interrogate pharmaceutical environmental and prescribing data in Scotland
- Evaluate ecotoxicological data, wastewater treatment data, and drug excretion profiles and physicochemical properties to develop environmental impact indicators
- Prioritise criteria through structured consensus and focus group activity
- Develop a robust decision-making formulary framework through novel application of Bayesian Belief Network modelling, considering both environmental and clinical factors
- Engage with patients and public representatives to assess awareness of the issue, perceived importance, and how to engage patients/public in prescribing activity
- Engage with healthcare practitioners and prescribers to assess how to make sustainable prescribing choices, and suitability of the proposed framework
How will this work be done?
- It will use the novel visualisation tool launched by SEPA on behalf of the OHBP, which includes data on medicines detected in the Scottish water environment and NHS Scotland prescribing data. Other data will be assessed to develop environmental impact indicators for the prioritised pharmaceuticals through a classification process similar to the Stockholm Wise List.
- It will use a Nominal Group Technique to work with various stakeholders across different sectors to achieve consensus in a structured and effective manner. This will be applied to prioritise criteria for the formulary (e.g., prescribing data, medical efficacy, safety and suitability, environmental risk data, cost), and review prioritised pharmaceutical from various resources (e.g., Scottish baseline assessment and legislative resources). Structured focus group activities will also be performed with various groups (e.g., public and patients, and healthcare practitioners and prescribers).
- The framework will be developed through a novel application of Bayesian Belief Network (BBN) modelling to create a multi-criteria decision support tool, considering both environmental and clinical factors. BBNs are probabilistic graphical models that allow integration of diverse data (qualitative and quantitative) in a trans-disciplinary framework, including socio-economic and biophysical aspects, while accounting for uncertainty and enabling causal reasoning. This will integrate stakeholder and expert knowledge (qualitative data) with quantitative data and resources. The model will be parameterised using data, literature, and expert knowledge elicited in a structured manner, and uncertainty will be represented by specifying conditional probabilities between related variables. Sensitivity analysis will be applied to identify critical areas for further data collection and model improvement, to ensure robust and appropriate model development. To our knowledge, this will be the first application of BBNs to the assessment of environmental impacts of drug prescribing, incorporating and building on recent advancements of BBN modelling in environmental risk assessment. This project will demonstrate the broad applicability of BBN methodology in risk-based environmental modelling and assessment, and promote uptake and added value in healthcare and other sectors to address complex, emerging sustainability issues.
- The framework will be co-developed with the research team and stakeholders in a structured and trans-disciplinary way to ensure repeatability, robustness and opportunities for updating/development as more data/information becomes available. Post-project activity will consider incorporation of wider sustainability factors (e.g., LCAs including procurement, transportation, carbon footprint).
What are the expected outcomes?
This project will demonstrate a novel, trans-disciplinary approach to address complex sustainability issues through integration of public health, environmental science, and social science methods and data.
Expected outcomes are to:
- Introduce new (to the NHS) data sources as indicators of environmental impact into the formulary process,
- Develop a robust decision-making framework for formulary recommendations which can be built on and adopted at UK- and international-level,
- Increase awareness amongst healthcare practitioners, prescribers, pharmacists, and the public of the environmental impact of medicines.
How will outputs be shared?
The research team and committed to embedding transparency and dissemination into this project. The OHBP’s project page will be updated with research outputs and other activity as this becomes available. These will also be available through the research team’s organisations, and the UKRI MRC website.
Dr Lydia Niemi (firstname.lastname@example.org) can be contacted with questions or for more information.