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
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
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.