ePI - electronic Product Information initiative

First ePI pilot performed

The creation and testing of ePIs, electronically structured product information, in real regulatory procedures has been explored through a one-year pilot initiative by HMA, EMA and the EC to enable the transition to the electronic system for medicines evaluated both nationally and at European level. For details please refer to the EMA conclusion report.

EMA and the national competent authorities of Denmark, the Netherlands, Spain and Sweden have tested ePI creation and management in 23 real regulatory procedures of variation applications. Involved pharmaceutical companies have been trained and equipped with guidance material.  

The pilot concluded in July 2024, and the outcomes will inform how to integrate the ePIs into common practice and expand their use across the EU.

Next step

ePI is using a FHIR-adapted format. FHIR is a technical standard facilitating interoperability with other e health data from different sources. Next step as an outcome from the pilot is to upload FHIR validated ePI files rather than creating from start in the portal tool. A small pilot for FHIR upload and other technical development will start in early 2025.

What is ePI?

ePI refers to the authorised, statutory product information for medicines (including the Summary of Product Characteristics, Package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print.

Electronic product information is intended to contain structured elements (for example consistent, fixed headings and controlled vocabularies), which will enhance accessibility as well as possibilities for search functionalities. This will enhance availability for use within e-health systems used by the health care, pharmacies and patients.

Formats such as PDF, Microsoft Word or other text file formats are not considered to be ePI because these do not deliver the benefits to stakeholders outlined in these principles.

Project in Sweden

To enable this digital format for product information for medicinal products, a national project has been started by the Swedish Medical Products Agency (Swedish MPA).

During 2022 the Swedish MPA has developed a Proof-of-Concept model including an XML template adapted for an editor tool for creation of electronic structured SmPC:s. The technical format XML (eXtensible Markup Language – compatible with the FHIR standard) is defining content and place in the template for the information. In the editor tool an SmPC could be created with information readable for machines as well as for the human eye.

In our Proof-of-Concept model, information elements are divided into categories depending on the nature of the information content and/or place within the template. The structure includes information fragments and coded information elements, including electronic structure of the product information template in headings and sections. Our model illustrates information inserted as defined elements coded to other data sources as well as coupled to meta data which will enable further data extraction.

In a workshop, held the 28^th of March 2023, 10 representatives of pharmaceutical companies had the possibility to participate in an on-site creation of electronically structured product information in our Proof-of-Concept model editor tool according to our XML scheme and template.

A conclusion from the participants of the workshop was that our concept enhances the willingness to structure as well as standardize and harmonize product information. This will in the end facilitate combined use of other e health data.

Among others, the following development objectives were discussed:

• possibility to migrate already structured texts directly into the tool
• prompt functionality for duplicated information
• prompt functionality for omitted information or omitted structure, for example if a section is not tagged correctly as a section or a tagged section is unintentionally left blank
• when using the functionality for implementing coded information (for example MedDRA terms) there should be a possibility both using codes, wordings or even parts of words and thus generation of proposed terms
• individual adapted filter function (for example choice of subheadings).

Two projects – one goal

Our Proof-of-Concept model has only been developed as a platform for discussion of further development of the fragmentation and structuring concept. The EMA tool and portal will in the end be used for creation, approval and publishing of all product information regardless of procedure type.

During the coming years, the Swedish MPA will work with both the national project, as well as being involved in the EMA project, and the end-goal is to merge the two projects by incorporating the results and experiences from the national project in the European project. The transfer into any new format will be stepwise. A challenge will be to create and/or convert around 50.000 documents into a new format.

The project has been discussed with stakeholders such as the pharmaceutical industry, representatives for pharmacies, patient organizations and the Swedish health care system.

Package leaflet paper version will remain

While ePI is product information in an electronic structured and coded format, it is not equal to replacing the paper leaflet with an electronic leaflet. Electronic product information in other formats already exist as a complement to printed versions.

Examples how the structure could be used

Structured product information will be published on the web page of the MPA as an open data source. Further use of the information could be development of search functionalitites or combining the information with other e-health data in user and decision supporting system.

Patient

When searching for an over-the-counter medicine, the patient might search for a combination of an indication, his/her age and possible intolerances and achieve a list of matching medicines. Further searches or comparisons of these medicines may be performed by such a search tool.

Prescriber in cooperation with the pharmacy

Another example could be where the pharmacist needs to contact the prescriber regarding a lower dose than expected has been prescribed.

In a structure product information, data element such as ”special population” (subheading) could be connected to patient data from the patients journal and retrieve certain information to be delivered at the pharmacy.

Miscommunication between the pharmacy and the prescriber could be avoided. Any additional information related to a certain patient may also be communicated, such as relevant interactions or contraception information.

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