The following article is credited to Datapharm’s Chief Digital Officer, Arif Govani, following his answer during a Q&A in our webinar, ‘The future of electronic Product Information (ePI)’.

Up to now, the QRD (the European Medicines Agency's Quality Review of Documents) template has played a vital role in how electronic product information (ePI) for medicines is displayed to HCPs (Healthcare Professionals) and patients.

Now through HL7 FHIR (Fast Healthcare Interoperability Resources), there lies the potential to make a huge impact on the patient experience, such as how they interact with ePILs (electronic Patient Information Leaflets), while empowering them with better decision-making.

With this in mind, could FHIR replace the QRD templates we use today?

This is a bit like asking: “Is the electric engine going to replace cars?” - one contributes to the other, rather than replacing it. Both will ultimately lead to a significantly changed experience with far-reaching long-term improvements.

So, to use the aforementioned analogy, think of the QRD as the shell of the car, and FHIR as the engine:

What is the QRD?

The ‘shell’ of the car - the QRD (the European Medicines Agency's Quality Review of Documents) is a set of document structure templates, in particular the templates used for the Product Information and SmPCs (Summary of Product Characteristics) used by marketing authorisation holders across the Pharmaceutical industry.

An example of a QRD template in use. Shown on the right-hand side, the QRD template defines how the SmPC is structured in order for HCPs to effectively look up product information.

What is FHIR?

The ‘engine’ - FHIR (Fast Healthcare Interoperability Resources) is a data standard developed by HL7. It’s the global industry standard for passing healthcare data between otherwise unconnected systems. It means that huge amounts of healthcare information (more than any other previous standard) can be digitised and interpreted by computers and shared with other systems.

How does FHIR contribute to the QRD?

Because it’s a data standard, FHIR is designed to understand and interpret the kind of information contained within the QRD and, when correctly coded, to understand the whole breadth of medical information contained in any other clinical document.

Similarly, it can then use that information to create new documents. So FHIR will allow digital clinical pharmaceutical information to be presented in document form in an infinite number of ways.

One of those ways is to replicate the existing QRD. Therefore, at this present moment there’s no reason for the QRD we’re all accustomed to today to be rendered obsolete. However, with an agreed terminology underpinning the documents, the industry will be able to standardise the way information is technically presented in the QRD, enabling us to avoid unnecessary variation and complexity.

The practical benefits of FHIR

As FHIR powers interoperability and separates the document’s data from the design and visuals associated with it, it can also be used to present QRD information in many new ways. This, for example, includes customised or personalised versions of the QRD. For example, a future bespoke QRD might highlight a contraindication which is particularly relevant to the patient because she is pregnant.

What does the future hold for the QRD?

The QRD is designed to ensure consistency across the Pharma industry and a means to standardise communication with patients using patient leaflets in ePIL form. It has done so up to this point by insisting on a particular format. FHIR, however, enables us to use a superior format for the patient experience, and will allow that same consistency and effective communication in new ways.

Therefore it’s not accurate to suggest that FHIR is going to replace the QRD template. It’s probable that FHIR standards, and the processes that they unlock, will give us substantially more flexibility with disseminating downstream information to the HCP and patient.

How is Datapharm supporting Pharma with structured product information?

Datapharm continues to support Pharma with improving the publishing and visibility of their product information to HCPs and patients. To find out how you can make your medicines information readily available and more accessible to HCPs and patients, get in touch with our team today.

To learn more about the topics discussed above, watch our webinar on-demand, 'The future of electronic Product Information (ePI)'.