Introducing patient-centric electronic medicine leaflets in the European Union

Abstract

Despite numerous advances in their content and structure over recent years, paper information leaflets for medicines are often hard to read for people with visual impairments, contain a lot of technical information, and people suffering from chronic conditions may find it challenging to identify all side-effects or dangers of taking a drug in their situation. Likewise, for people already taking different drugs, identifying contraindications may be time-intensive and easily overlooked, posing a risk for affected patients. Electronic product information (ePI), or eLeaflets, provide an opportunity for improvements in how patients interact with the information provided. We summarise opportunities of ePI and experiences from a co-creation process of such an app together with patients as part of the Pharmaledger project and put it into context of the current policy environment in the EU in light of EMA’s key principles for the adoption of ePI in medicine. While more patient-friendly information remains a significant ask, ePI has the potential to make leaflets easier and quicker to read through search and zoom functions, provide a safe digital medicine cabinet employing blockchain technology, enables patients to identify falsified product boxes, receive real-time updates when a product expires or is being recalled by the manufacturer, and potentially even include a reminder function to increase adherence. We present a potential research agenda across disciplines for interested researchers. While many welcome the benefits of ePI, we urge policymakers to keep in mind that some groups, specifically people with low technical literacy, should not be left without alternatives. We recommend early initiatives to ensure a widespread understanding of how ePI works across populations while also taking this opportunity to use new insights to improve leaflets on paper.