In this first post we will be looking at the EU initiative exploring the introduction on an electronic Product Information (ePI) for human medicines authorized in the EU. We will also be looking at how the eLeaflet solution fro myHealthbox performs against the requirements set forth by this EU ePI initiative.
Specifically Part 1 of this series will look at the "status quo" for this initiative, the rationale for introducing this technology and the features expected from an ePI implementation which have been divided into 3 categories:
ePI data should be freely available for use and reuse so that they become a resource for third parties, such as researchers, developers, organisations and businesses, as well as authorities outside the EU.
The eLeaflet solution from myHealthbox is based on open, web based, standards. Information is freely available and distributable.
ePI should be accessible directly from the medicine package, for example by scanning a barcode on the package.
The eLeaflet solution from myHealthbox already supports a variety of codes available on packaging as well as text searches based on barcodes. The most common implementations support a QR code which in most cases does not require a dedicated application or reader but can be scanned in quickly from any smartphone.
Some changes to a medicine, such as a change to an excipient, could mean that a different ePI would be valid for different batches of a medicine. For example, older batches of a medicine that are still ‘on the shelf’ could have a different ePI to newer batches being released from the manufacturer. Therefore, it should be possible to link each medicine package in a particular batch to the correct, batch-specific ePI.
The eLeaflet solution from myHealthbox already supports this feature, an eLeaflet can be linked to a specific product or to a specific batch of products (batches must be identified by unique numbers). A search for the product will present the user with a list of batches where each batch may have different product information.
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.
The eLeaflet solution from myHealthbox already supports this feature which is available on the myHealthbox search engine (only for users with a full license) or via APIs.
ePI content should be secure and protected against unauthorised changes.
The eLeaflet solution from myHealthbox implements a very strict protocol to guarantee that data is packaged in a way that cannot be modified.
The full list of features includes:
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.
The eLeaflet solution from myHealthbox does not ask nor use any personal information unless strictly necessary and only after explicit consent from the user. Features that require input of personal data like the "Pill Reminder" and the "Dosage Calculator" follow all existing privacy regulations in regards to data collection and usage. All analytics data is anonymized.
More information about the eLeaflet solution from myHealthbox is available on the eLeaflet website