Electronic product information (ePI) for selected human medicines has been published for the first time by the Heads of Medicines Agencies (HMA), the European Commission (EC) and the European Medicines Agency (EMA).
Publishing this critical information on how medicines should be prescribed and used in an electronic format marks a step towards more digitally enabled healthcare systems and provides consistency across all EU Member States.
It also allows pharmaceutical companies to monitor product information and keep it constantly updated, as well as offering healthcare professionals and patients greater accessibility.
Juan García Burgos, head of public and stakeholder engagement at the EMA, said: ‘Electronic product information will allow for the latest information about a medicine to reach end users like patients and healthcare professionals as quickly as possible.
‘This means that, with ePI, healthcare professionals can be confident that the information they have at hand about the benefits and safety of a medicine or about how a medicine should be used is the most up to date. This is not the case with paper product leaflets, for example, which are updated more slowly and replaced gradually as medicine stocks turnover.
‘The digital format of ePI will allow healthcare professionals to find information and run searches amongst different medicines more easily, helping with treatment decisions.‘
Electronic product information pilot
The ePI uses a semi-structured format based on a common electronic standard for product information adopted by the European medicines regulatory network. They are available in English for centrally approved medicines and in the local language for those that are nationally approved.
As part of a one-year pilot project by the HMA, EC and EMA, there are currently seven ePIs published in the Product Lifecycle Management (PLM) Portal. These medicines have been evaluated by the EMA or by national authorities in Denmark, the Netherlands, Spain and Sweden.
Pharmaceutical companies participating in the pilot create and submit the ePI via the PLM Portal as part of their regulatory application.
The full pilot involves 25 medicines and will conclude in July 2024. According to the EMA, outcomes will inform how to integrate the ePIs into common practice and expand their use across the EU.
Future developments to the digital system could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction reporting tools, the EMA said.
Dr García Burgos added: ‘Also, in the future, ePI could be used as input to electronic platforms like electronic health records, e-prescribing systems and clinical decision support tools all using the same trustworthy information as a source.‘