Update on national pilot study for pharmaceutical companies creating ePI

Update on national pilot study for pharmaceutical companies creating ePI

In 2022, the Swedish Medical Products Agency (Swedish MPA) selected Fonto as the editor of choice for the creation of electronic structured SmPC’s. Over the past few months, the Swedish MPA has developed an XML template adapted for Fonto.

Electronic product information

In a Proof-of-Concept model, information elements are divided into categories depending on the nature of the 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. The model illustrates information inserted as defined elements coded to other data sources as well as coupled to metadata which will enable further data extraction.

Such electronic product information (ePI) 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.

Examples how the structured content can 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 functionalities or combining the information with other e-health data in user and decision supporting system.

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.

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, a data element such as ”special population” (subheading) could be connected to patient data from the patient’s journal and retrieve certain information to be delivered to 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.

Workshop with pharmaceutical companies

“After a smooth development period, the application has been presented internally. Functionality is according to plan and the robustness of the editor together with our configured XML template has been tested by the internal team” Kim Sherwood, project manager at the Swedish MPA says.

The Swedish MPA is now ready for and proud to present a workshop in March where pharmaceutical companies are invited to create an SmPC in Fonto Editor according to the defined structure. The input will be transferred into further development.

The team at the Swedish MPA is looking forward to the workshop and already thinking about the next steps. According to Kim Sherwood: “An interesting topic to investigate would be further use of the created SmPC XML files for FHIR adaption.”

To be continued…

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