Electronic package leaflets

Access to drug information would be better if it was provided electronically. And it will be soon. 

UM – 03/2022

Survey of hospital pharmacists

A report released in mid-February of this year by the European Association of Hospital Pharmacists (EAHP) showed that access to information for everyone involved would be greatly improved if hospital patients and their caregivers could access ePI (electronic Product Information) for each of their medicines.

Product Information = Package leaflets + SmPC

The product information listed in the PI for patients also includes a summary of the product’s characteristics for healthcare professionals (SmPC). These documents accompany each and every drug approved within the EU and they explain how it should be used and prescribed. Today, they are used partly digitally and partly in paper form - by doctors, by nursing staff and also in hospital pharmacies. This information often does not (yet) reach the patients in hospitals. If the hospital pharmacists surveyed are to be believed, then there is great potential here for providing product information in electronic form.

European ePI project

The survey was conducted in the lee of a broader ePI project that will establish a common electronic standard, prototype, and roadmap for paving the way for introducing harmonised, ePI for medicines for human use within the EU. The process was initiated by a network consisting of the European Medicines Agency (EMA), the association of national regulatory authorities for human and veterinary medicines in the European Economic Area and the EC at the end of 2018 (see DSV NEWS April 2020).

Common standard established

The European Network for Regulating Medicines adopted a common standard for ePI (see here) on February 22. The Common EU ePI Standard is based on Fast Healthcare Interoperability Resources, an international technical standard that describes data formats and elements as well as an application programming interface for exchanging electronic health data.

This ePI is an essential step towards improving how information is provided to patients, consumers and health professionals to help support their decisions. Digital technology can make the complex information easier to understand and provide both faster and barrier-free availability. The ePI can be updated as new information becomes available.

Test phase has started

These ePIs are part of the EC's pharmaceutical strategy. A follow-up pilot project supported by the EU4Health funding program will now focus on developing the tools and guidelines needed to test the use of ePI prior to its introduction.