Under control
In comparison to today’s primarily paper-based system, electronic health records (EHR) would provide greater accessibility and improved information quality and transparency, says Colin Walsh, Head of Life Sciences at Capgemini UK.
22 September 2008
Publication
In comparison to today’s primarily paper-based system, electronic health records (EHR) would provide greater accessibility across both primary and secondary care, plus improved information quality and transparency. Payers would get greater quality control and the opportunity to build incentives for quality care, while providers would see increased patient safety, greater support for evidence-based medicine, and improved operational efficiency.
Patient safety would increase because of EHR’s visibility at point of treatment, as well as earlier identification of possible adverse events.
Benefits to pharma
The potential benefits for patients, payers and providers are well documented, but what could EHR offer to pharma marketers?
Although this is not something we can afford to take for granted, let’s assume that companies will be given access to health service records (as we’ll discuss later). If this were the case, EHR data would bring three key benefits: cycle time reduction, improved drug safety and better product planning.
EHR can speed up cycle time through better recruitment of participants for clinical trials. Companies can interrogate patient records to identify the most concentrated clusters of patients, and then improve recruitment rates and enrolment times by targeting those areas. Early adopters of this approach in the US, working with EHR data from private healthcare, confirm that it is faster and more accurate than conventional recruitment methods.
EHR can also speed up cycle times by replacing conventional studies with “virtual studies”, where the drug is launched earlier for a limited indication and then its label is expanded as we gain experience of its use, supported by close monitoring and data collection via the EHR system.
Cycle time reduction means that drugs can be brought to market sooner and for less cost, offering marketing advantages. Easier collection of clinical data via EHR means marketing departments will also have more time to prepare launch materials containing more convincing data (as we will see how the drug is actually used in practice).
EHR will also offer companies the potential to improve drug safety. “Post-marketing surveillance” will be simplified through the ability to extract data via the EHR about the safety of drugs that are already in use for subsequent analysis. This will give companies solid data from an independent source, in greater volumes and from a more representative sample of the population than can be obtained in traditional clinical trials. Marketing can use that data to show patients, clinicians and payers that they are receiving safe, effective products.
This approach could further reduce cycle time as companies will be much better placed to monitor safety post-launch, and as a result, may be allowed to launch earlier with less initial safety data. This means patients could have access to novel drugs sooner, with reduced risk.
When it comes to product planning, companies will be able to improve the treatments they offer to patients by obtaining a better understanding of the market. By using consolidated EHR data, marketing professionals will be able to spot gaps where treatments are needed, and trends that show where gaps will open up in the future (eg where a particular disease is becoming more prevalent). This will allow their companies to make better informed go/no-go decisions about the development of new molecules.
Environmental scanning – for example, tracking the rise of conditions such as obesity – will be more effective with access to accurate, nationwide records. If genomic information becomes available, companies will be able to identify patient groups with a high risk of developing conditions in later life and try to provide preventative drugs.
Of course, much of the data that companies could obtain from EHR databases is already available in limited quantities from sources such as commercial market information databases or in-house data warehouses. EHR data, however, could provide comprehensive, consistent and independently gathered data, from a single source. What’s more, it would be the very same data that clinicians and payers would rely on, so healthcare marketers would share the same perspective as the people they are talking to. We anticipate, however, that EHR would initially be used alongside existing sources.
Obstacles to use
Before EHR can deliver these benefits, there are significant obstacles to overcome. Some of the most important relate to confidentiality of personal data, and to the threat of companies losing control of their clinical data.
Confidentiality is of particular concern to the public in the wake of various highly publicised leaks of personal information by government departments. Given that many patients have reservations about allowing their data to be held electronically for clinical purposes, will they ever be persuaded to allow its use by pharmaceutical companies?
Patients are more likely to agree to the use of their data if they know the end result will be safer, more affordable treatments, sooner. Arguably pharmaceutical companies’ marketing functions are ideally placed to contribute to public education in this area. Clearly, public bodies also need to tighten up their data protection procedures and, if they haven’t already done so, governments must pass legislation to protect the confidentiality of medical records.
Under legislation like this, patients can be invited to “opt in” to sharing their personal data with healthcare companies for specific purposes, such as clinical trials or remote condition monitoring. Alternatively data could be shared with pharmaceutical companies anonymously, a proposition that is likely to be attractive to the public from a guaranteed privacy point of view.
The rise of EHR systems could mean companies surrendering control of data they currently regard as their own. Rather than pharmaceutical companies collecting data through their own clinical trials, ultimately 90–100 per cent of data could be captured via an EHR.
There are undoubted risks attached to relinquishing control. The Vioxx experience demonstrated what could be perceived as the downside of having records held outside the company, as an EHR system belonging to a healthcare organisation played a part in the safety alert.
How to prepare for EHR
Companies need to think about how they will live with the risks because, whether we love the idea or hate it, the eventual ubiquity of EHR looks inevitable (if not particularly imminent given the IT challenges involved). If they have not done so already, pharmaceutical companies – including their marketing specialists – would do well to start preparing for it now. By getting involved sooner rather than later, they have the chance to influence what the new world will look like.
If pharmaceutical companies do not establish themselves as stakeholders early on, there is a serious risk they will not get adequate access to EHR and find themselves marginalised, having to follow developments rather than lead them.
The collaborative nature of EHR, and the new patterns of data ownership associated with it, make it essential to develop appropriate governance frameworks early on. Stakeholders need to get together to decide who will own what data, and how access will be controlled. If these questions are negotiated carefully early on, then companies should be able to ensure the risks associated with relinquishing control of clinical data are kept at an acceptable level, and that the benefits make the risks worth accepting.
Pharma will also have the opportunity to influence the technical standards to which EHR systems are developed. At present a pan-European standard looks to be a distant possibility as most national standards have yet to be determined. Although it is unlikely that the systems will adopt a uniform design, the industry can lobby for a consistent approach that will make it possible for healthcare companies and others to work with data from different countries in a relatively seamless way, just as accountancy systems use “schemas” to exchange data between them.
What can companies do to promote the outcomes they desire in areas like governance and standards? Collaborating as an industry to develop a unified point of view, and communicating this to health services, will be essential. There are already initiatives with this as part of their remit, such as the eClinical Forum and the PhRMA EDC/eSource task force. Some companies, such as Pfizer, have taken a lead by publishing research in this area .
Marketing must lead
Most of the collaboration we have seen to date focuses on research and development (R&D). Marketers need to get involved too or, better still, take the lead, to ensure their needs are met by the standards, governance and other arrangements that are negotiated. Third-party advisors also have an enabling role to play because they understand the business issues for the healthcare industry, the technology landscape of EHR, and the relationships between key decision-makers across the healthcare sector.
The most important step that pharma can take, however, is to convince health services and the public that they ought to be regarded as stakeholders in EHR and provided with appropriate access to data – something that is far from a foregone conclusion at present. Clearly EHR programmes could benefit from funding from pharmaceutical companies (cost is acknowledged as the biggest barrier to EHR adoption), as well as from their research expertise. Having said this, the industry must not be seen to have undue influence.
Marketers know better than most how to strike the right balance. They can help
their companies demonstrate why their involvement is in the public interest. For
example, they can explain why access to EHR will enable faster drug development
at lower cost and with greater safety and transparency.
An equally fundamental way in which marketing specialists can prepare for EHR
is to get to grips with the data sources that are available now. The UK’s GPRD
already offers an unparalleled opportunity to look at drug utilisation and safety
in the community. Currently it is mainly used by R&D departments. By treating
a service like this as a prototype, marketers could firm up their ideas about
what they really want from EHR.
Colin Walsh is Head of Life Sciences at Capgemini UK.
To read this article in full at pmlive.com, click here.
