The patient information leaflet becomes digital


The European Medical Agency (EMA) and the European Commissions launched a public consultation on main principles governing the development of electronic product information (ePI) for medicines distribution inside Europe.

All stakeholders and citizens are invited to send their comments filling an on-line form until 31 July 2019.

The electronic Product Information (ePI) will include pack the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. These documents accompany every single medicine authorised in the EU and explain how it should be used and prescribed.

The public consultation main principles were derived from discussions and consultations among the representatives of all interested stakeholder groups: patients, healthcare professionals, regulatory agencies and pharmaceutical organizations. During the workshop held in London on 28 November, a report was presented containing the main principles as published yesterday and a video.

The document shows the benefits for public healthcare foreseen by the ePI introduction and defines how it will be introduced in the existing regulations, as additional complement to the Product Information leaflet.

Among the expressed principles we find:

  • The use of open formats
  • The use of SPOR (ISO IDMP – International Organization for Standardization – Identification of Medicinal Products) terminologies instead of free text where appropriate
  • Interoperability with other e-health systems, such as e-prescribing and dispensing, electronic health records, cross-border healthcare, clinical decision support systems and computerised physician order entry systems.
  • Link from medicine package. ePI should be accessible directly from the medicine package, for example by scanning a barcode on the package.
  • History of PI updates. ePI should support versioning, meaning that it should be possible to access historical versions of the ePI and note the changes that have taken place over time.
  • Data security. ePI content should be secure and protected against unauthorised changes.
  • Data privacy. Any use of ePI involving collection of personal data should comply with data protection legislation to ensure that patient privacy is upheld and that this is done legally.

At the end of the consultation a final approved document version will be prepared and referred to for ePI implementation process all around Europe

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