How is ePI going to transform the use of Pharma’s medicines information?

Discussions around digital product information for medicines are making waves across pharma and healthcare.

Stakeholders from contrasting perspectives are now looking at how they can answer some of the industry’s biggest questions around patient outcomes by understanding what is possible by using improved standards for medicines information.

If you are involved in pharma and healthcare, there is actually more than one school of thought on what the acronym, ePI, encompasses. So, to provide some clarity, the two terminologies in question are:

• electronic Product Information – the authorised, statutory product information for medicines, such as the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), adapted to an electronic format which can be disseminated online, via apps and on paper.
• electronic Patient Information – the regulated medicine safety information written for the patient - the PIL, but in electronic form. (on emc, a large portion of pharma companies provide this as ePIL)

As a healthcare technology company, and the providers of emc, Datapharm are well-placed to provide some insight on these two topics separately and their impact on pharma regulatory processes in the future.

What is happening in pharma and healthcare with electronic Product Information (ePI)?

In healthcare globally, ePI refers to the electronic version of product information for pharmaceutical, medical devices, and other healthcare-related products. Specifically for Pharma, it is for information about medicines, such as the SmPC or PIL.

Underpinning ePI, there needs to be a common standard with information set in a defined coding structure for the industry to use. The answer which has been widely accepted by the global healthcare community is FHIR - Fast Healthcare Interoperability Resources (you can learn more about FHIR in our previous article but, for now, let’s focus on ePI itself).

Particularly within Northern Europe, the discussion around ePI is picking up pace as the global healthcare community works out what technical features ePI should incorporate. Of particular note, the EMA has began piloting the submission of ePIs as part of a company’s regulatory application for a select number of medicines.

As a Gravitate-Health partner, Datapharm remain central in the ongoing discussions, and in the implementation and testing for real-life healthcare scenarios. The Gravitate-Health project brings its partners to a number of events throughout the year where the technology’s capabilities, such as linking products cross-region, is tested.

The emc website (medicines.org.uk), run by Datapharm, holds a vast array of data which in future will be usable for a variety of practical healthcare scenarios and Pharma information processes by using a standard ePI. Datapharm is currently collaborating with industry partners to support the production of a standard ePI format for the industry to take advantage of.

Why is electronic Patient Information such an important area to pharma?

Back in 2006, Datapharm made the first published xPILs available on emc. The premise of this format was to ensure that patient information leaflets (PILs) are converted into a true electronic format and are accessible to everyone, including patients with special requirements.

Fast forward to 2023, and coverage of xPILs – now termed ePILs (electronic Patient Information Leaflets) – has grown significantly, with 147 pharma companies (and counting) providing patient information for medicines in this format on emc. Evidently, ePILs are being widely accepted and provide this important safety information as a more accessible, intuitive and safer alternative to PILs in PDF or paper form. Furthermore, the ePIL format aligns with improving interoperability which a standard ePI is designed for.

In the pharma industry, the UK Electronic Patient Information Taskforce has been set up to ‘facilitate a move to user-centred, digital-first medicines information that is inclusive and accessible for all, better for patients and the environment’. What exactly this new digital information will look like, and how it ensures no one is left behind, is yet to be decided, but the ePIL has been widely acknowledged as an accessible format to help solve these challenges and increase patient engagement in regulated safety information.

The taskforce is working hard to make its vision become a reality, for which discussions are now beginning to involve the regulator, the MHRA, as well as some of the world’s leading pharma organisations.

More recently, a desire has been expressed to involve NHS England in the project. This should be welcomed by the industry as the NHS itself begins to implement FHIR in a select number of digital healthcare projects. So, other than being the UK’s treasured Healthcare service, it has technical insight that feeds through to the patient experience.

There are many practical hurdles to overcome – for example, how will the pharma supply chain adjust to the removal of paper leaflets in its packaging, and how will the relevant scenarios be piloted?

But clearly, this project is a highly relevant piece in pharma’s journey to a standard ePI for medicines, which will lead to transforming how pharma submit and disseminate their information.

How are Datapharm contributing to the future of medicines information?

As Datapharm provide medicines information to HCPs (healthcare professionals) and patients through emc, we are well invested in improving engagement from these audiences with this digital information.

Included in the above stakeholders’ visions is making medicines information globally interoperable, and there will clearly need to be large scale adoption by the healthcare industry for this to happen. Datapharm is able to play a crucial role in this global goal thanks to the implementation of FHIR for medicines information on emc, and through collaboration with industry partners to shape the use of electronic Product Information for medicine products.

Join the healthcare community to support global interoperability, with Datapharm’s support

How pharma and healthcare utilise ePI will shape the benefits, not only for improving how patients engage with their medicines, but also for pharma regulatory and supply chain processes. To have an influence on what benefits emerge from ePI, it’s vital to engage with the relevant stakeholders on this subject.

ePI is an open standard which any pharma or healthcare organisation can become involved in. To discuss or support the vision of global interoperability and improved patient engagement, get in touch with our team.