Written by: Philippe Michiels, Principal Architect at Datapharm
Pharma companies are compelled by law to publish regulated information alongside the medicines they market, but the way in which this information is presented to patients and healthcare professionals (HCPs) is far from optimal.
Currently, this information is unstructured, making it difficult for HCPs and patients to access and engage with; end users often have to sift through what can be extremely lengthy and confusing paper leaflets which contain every possible piece of information for that particular medicine. Digital versions , meanwhile, are typically in PDF format which is challenging for computers to process, making it impossible for interoperability to be achieved across care settings and international territories.
This results in situations where patients may be unable (or unwilling) to find the material they need. In extreme cases, this can contribute to the incorrect use of medicines and adversely impact patient outcomes.
According to the OECD, each year around 200,000 premature deaths in Europe relate to poor medication adherence, a situation which is also predicted to cost as much as €125 billion each year in avoidable hospitalizations, emergency care and adult outpatient visits.
The healthcare sector is therefore approaching a pivotal moment in the way medicines information is distributed and shared.
Organizations are currently sharing regulated medicines information in documents such as Word and PDF files to reach consensus on the correct level of quality. In a world that is accustomed to consuming digital information intuitively, this is not sustainable.
The need for more streamlined and standardized processes has never been clearer, as is the vast potential for improved engagement with HCPs and patients. What is more, there is growing evidence that patients prefer to access information digitally, in different formats, rather than paper formats.
The key to solving these far-reaching challenges lies in the adoption of a common electronic Product Information (ePI) standard. ePI is authorized, statutory product information for medicines (such as the Summary of Product Characteristics and Patient Information Leaflet) using structured data, and allows for effective dissemination of information between computer systems that adopt it.
There are several reasons or benefits which explain why ePI is moving further up the agenda for the global healthcare community. Its standardized use would open up the potential to leverage digital and structured information to provide multi-media, multi-language versions of the same paper-based medical information whilst also allowing the content to be adapted for people with different needs.
This will make information more accessible and relevant to individual patients, and thus decrease the likelihood of misuse or unintended outcomes.
The case for common standards
Successfully shifting to a new ePI model will help facilitate vastly improved interoperability throughout the healthcare ecosystem. Central to creating this environment will be adherence to a common set of standards.
This does not mean prescribing a rigid one-size-fits-all formula. Indeed, regional authorities will adapt the standard to meet their own needs, but the use of global open web standards and open source HL7 FHIR for medicines information data modelling and interoperability ensures data can be harmonized and interoperate across regions.
First emerging in 2012, HL7 FHIR is designed to enable healthcare data, including clinical and administrative data, to be quickly and efficiently exchanged. A core goal of the standard is to create a framework that leads to high adoption across disparate developer communities; it is therefore focused on being easy for software developers to use, by drawing on existing standards familiar to software developers outside of healthcare. This reduces the learning curve, makes real time interoperability easier, and enables faster and simpler application creation.
Datapharm has been influential in the development of a new standard ePI for medicines, working with leading medical information and pharma organizations throughout Europe.
In the UK, the National Health Service (NHS) has embraced the use of HL7 FHIR to process healthcare data and to provide terminology services. Medicines information on the electronic medicines compendium (emc) website, used regularly by HCPs throughout the NHS, is also transitioning to be based on HL7 FHIR which means data can be provided as a service to create a truly multi-purpose resource.
A new ePI standard, underpinned by HL7 FHIR, is able to support the delivery of several benefits.
Fully structured data will lead to a superior user experience compared to paper and PDF leaflets, not least because information can be presented and prioritized based on patient needs and preferences.
Patients currently have to navigate a breadth of medicine safety information contained within paper leaflets, and providing information in a structured format enables the tailoring of information so that they can more easily engage with it and find what they need faster. Furthermore, linkages with other patient-friendly content would make it possible to provide the patient with more data and context, enabling them to make more informed decisions. Critically, this would also help to address patient safety issues around incorrect use of medication.
Meanwhile, interoperability enhancements will unlock international medicine equivalence for international travelers. For example, if a British tourist ran out of medication while on holiday in Spain, an interoperable system will enable them to locate equivalent brands and products, with local language Spanish information, becoming available in English. Similarly, these capabilities can also help with identifying equivalent medicines in cases of cross-border medicines shortages.
From the pharma sector’s perspective, a system of highly structured medicines information using HL7 FHIR standards would be much simpler to keep up to date and share.
There are also important sustainability gains to be made from transitioning to a new ePI standard—by reducing the effect of printing and distributing around 100 billion leaflets a year, around 595,000 tons of CO2 equivalent can be prevented from entering the atmosphere.
Advancing adoption of the new ePI standard
Datapharm, provider of the electronic medicines compendium (emc), is now supporting pharmaceutical organizations in the UK with the standardization of their product information to HL7 FHIR. By standardizing all the product information available in the emc dataset, this endeavor will further strengthen emc as the gold standard for interoperable medicines information.
Datapharm also continues to work with stakeholders across the broader European region in a bid to harmonize ePI standards.
Much of this work is carried out through participation in the Gravitate Health consortium. This is a relatively new research body funded by Innovative Medicines Initiative (IMI), a joint undertaking of the European Commission that aims to improve access and understanding of health information. To achieve this, Datapharm has joined forces with more than 40 public and private organizations from 15 countries under the Gravitate Health umbrella.
This partnership will continue to push for a common and universally adopted ePI standard as the case for digital distribution of medicines information, and thus improving patient outcomes, becomes ever more compelling.
Momentum is building, with ePI starting to be adopted by regulators, compendia, health authorities and industry. This initial endorsement of the international standard is essential for wider adoption.
Datapharm is committed to ensuring that emc data is available in harmonized ePI standards, and as a result will continue assisting with wider ePI adoption both across the UK and internationally. Indeed, the company is committed to increasing uptake of the standard, and is shifting from a proprietary model to one based on an Open Source standard, free for anyone to use, which will enable organizations to transition to the new standard. This move to open up access is critical to achieving the global ePI movement’s aims of improved interoperability between healthcare settings and systems.
As such, Datapharm welcomes engagement from all parties regarding the development and implementation of modern standards in the creation and distribution of medicines information to ultimately benefit HCPs and patients.
For more information about ePI and where your company is placed on the maturity model, access Datapharm’s recorded webinar: https://bit.ly/3stWDZm
Written by: Philippe Michiels, Principal Architect at Datapharm