Health care is increasingly reliant on medicines as a primary therapeutic means, and medicines are increasingly developed, delivered and regulated by reliance on associated and accompanying data and information technologies. In this sense medicines are becoming more and more digitalised, embedded in and constituted by a rich and rapidly changing data ecosystem.

• The application to EPSRC funding for this project written in in 2013 included this general description of the project
• A brief introduction to the project is on the main LSE web site here (December 2014)
• The project leaflet, intended to inform our research participants, is available below on this page and  as a PDF D3 Leaflet Visuals
• News of the project is available on our blog, under the D3 tag

This research pioneers a new area of study, that of digital drugs. It brings together people with different backgrounds to share knowledge and understanding about current and future developments in how medicines are used and the digital systems they are embedded in. Using theories and models from studies of the digital economy – concepts such as digital materiality, platforms, digital business models, open innovation – we set new agendas for researchers, business and NHS managers, clinical professionals and policy makers. We will enable better strategy-making among key stakeholders as well as spurring further research.

Until recently most medicines were developed, tested and licensed for specific uses, and manufactured and distributed in standard doses. But things change with new developments in the ways that medicines are developed, supplied and used and new policy for patient-centric care. Much of this change is dependent on using information technology, networks, databases and other kinds of software to help safely and efficiently deliver the right medicines for patients and the right information for all stakeholders. Thus as people work with and use medicines, they work with not just a specific chemical or molecule in a standard dose, but with a lot of digital resources and information services that let them refine these uses. Medicines are now a hybrid, in part physical product (a chemical), part an informational product (data and information), and part a service (algorithms) that a user interacts with.

Still, medicines are often not used to their full potential or safely; research estimates that 1 in 5 of hospital admissions are related to inappropriate use of medicines. Error rates in medicines use are high, sometimes leading to serious harm. The toll from misuse of medicines may be reducible by applying digital technologies – a more intensive digitization. The UK NHS has, for example, undertaken major projects in the last decade to computerise prescribing and the transmission of prescription data for both GPs in community settings (primary care) and in hospitals (secondary care), as well as to improve patient understanding of their medicines and thus their ability to participate actively in taking them.

This project will map out the full range of digitisation initiatives underway today. We will study in more depth a carefully selected set of about five examples. To collect this data and analyse it, and to provide a detailed overall model of the digitization processes at work (the why, and the how), we will need to develop some new tools to describe medicines in their digital character. Here we can borrow a number of contemporary ideas from other studies of the digital economy, innovation and business models. These tools and models, which we will document and distribute, will be useful for other people who want to understand digital drugs and other complex products and services that are changing as they embody more data and connectivity.

This research is useful and important. It may help to address the needs of our aging population with multiple, treatable chronic (long term) diseases such as diabetes or high blood pressure. New medicines will become available that depend on data rich and multidisciplinary practices, flexible and reliable supply chains, and active patient participation. They will draw upon medicines’ digital resources and be delivered through new business models, perhaps very different from today. Three examples illustrate these ideas; 1) the kinds of smart pills that transmit data from inside your body to a mobile phone as they are taken and help to ensure that you take the right dose at the right time; 2) innovative patient centred information systems as a basis for new approaches to managing diabetes in the community, 3) the potential of replacing high street pharmacies with a small number of an ‘Amazon’ type online supplier.

OBJECTIVES Of THE PROJECT

This research investigates the increasing digitisation of medicines as they become embedded in a range of new digital systems that generate and provide value for health care systems and which may lead to new business models. We study the ways that digitization contributes to, or is a consequence of, medicines shifting from a product that is ‘packaged’ both physically and informational, to an ‘incomplete’ product that is bound into a range of digital services and platforms. That is, from standard, universal, pre-manufactured pill to something finalised on demand and late in the day within a specific context, using real time data resources and services responding to specific patient need or medical professional recommendation.

This project takes an integrative focus on the digitization of medicines, in particular in the activities ‘downstream’ from drug discovery. The project focuses on the development of digital resources for medicines as they move from developmental status into medical practice with accompanying informational resources and flows. These digital resources (seen as infrastructures, services and platforms) pose many complex intersecting concerns; of what is beneficial and appropriate, how value is generated, realised and captured, how data is managed and used, and accompanying possible changed professional practices. Issues raised include those of ensuring safety and managing risk, as well as of ethical data governance and finding the appropriate role for patients including in respect to the uses made of their personal data.

The objectives of the research are thus to:

1. To document the changing nature of medicines (their developing digital materiality) as they move more towards a status as an incomplete product and become encrusted with digital features and embedded in a new data ecosystem.

2. To map the various endeavours underway to digitize medicines and to undertake in-depth studies of 5 such areas, purposively sampled on the basis of the initial review (the 5 case studies)

3. To establish to what extent, by what means and how fast processes of medication use are digitized, scaled, cross linked and governed. To understand the drivers and inhibitors of these changes, and how they affect the creation, realization and capture of value from medicines.

4. To research and model the consequences of such developments for major stakeholder groups and their practices. To establish how, where and for whom digital drugs create or add value, and the new or changed business models, work practices and behaviours that develop.

5. Assuming that consequences are beneficial (for some), how can they be promoted, and as they are disadvantageous (for some), how may they be restricted. Thus to develop resources and conceptual frameworks that will help various interested stakeholders (clinicians, managers, policy makers, patients) understand and work with digital drugs.

6. To identify a new research agenda in this area for subsequent study.

IMPACT SUMMARY

The impact of this project is seen through its ability to connect and respond to various constituencies of academic, business and clinical users/managers who share an interest in the future of medicines and their informational infrastructures. The rate of change in the sector and the degree of new innovative digitisation initiatives create an as yet unmet need for support and sharing of relevant and applicable conceptual structures. We will offer this diverse set of actors applicable theories and models of digital change, their own networking opportunities and shared agenda setting, and a means to establish negotiated common goals.

This project aims to meet these diverse needs as well as to work to foster and extend the UK’s significant role as a producer of novel and innovative pharmaceuticals and its reputation as an innovative, responsive and safe user of them. We see policy makers and senior manages within the NHS. in associated suppliers and professional regulatory bodies and organisations with a desire to refine their understanding of the potential for beneficial change and of the new business models emerging. We still see constituencies that are confused or even dissuaded by the difficulty of framing and sustaining digital initiatives. Our research agenda will deliver tangible and applicable benefit to these primary stakeholder groups who include software and service suppliers, policy makers, professional bodies, patients and their representatives and regulators in health care.

This work is exploratory and opens up a new field of study, to support this we will have a well chosen and appropriate Advisory Board with industry and practitioner members and engage with the wider public debate through Public Lectures. We undertake many engagement activities and purse an active on-line strategy using video, blogging and targeting the trade press. Our Open Conferences will be designed to attract and inform practitioners, managers and policy makers in this area. Their interests will also be served by he production of the Policy Briefs and patient oriented resources.

One of the impacts we should have is to catalyse more research, and more focused research that can respond to identified stakeholder needs. This research should also establish a set of models and approaches for others industries or sectors to consider as they too evaluate and perhaps embrace new digital business models and as digital materiality becomes embedded in their new work practices.