EU Seeks to Digitize Drug Information for Easier Patient Use

As patients are being encouraged to self-manage disease and take an active role in their healthcare, communication with patients about the products that they use is becoming a hot topic among drug makers. During the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, stakeholders gathered to discuss new directions in providing digital information to patients.

Recent studies have demonstrated that package inserts for biosimilars available in the European market may not be serving the purposes for which they are intended, may go unread, or could even alarm patients who do read them.

Kevin Airey, MPharm, director of regulatory affairs at Mylan, underscored that fact, saying that in 2013, a European Commission assessment reported on shortcomings of patient leaflets and summaries of product characteristics, and a number of recommendations were identified. Development of electronic formats for communication was noted as a top priority in a 2017 European Medicines Agency action plan on the matter.

In the future, he said, content should be easier for people to understand, and could integrate other materials, such as lay summaries of European Public Assessment Reports or extra educational materials. Digital formats also bring the potential for real-time updates to information and user-friendly interfaces.

Kaisa Immonen, MA, director of policy at the European Patients’ Forum, added that, currently, many people do not use package leaflets. A recent EU-based survey found that 27.5% of people found understanding the leaflets fairly difficult or very difficult, which is a concerning fact given that, “for many people, it’s the only piece of information they get” about their medicine.

She added that EU citizens are also increasingly look for information online. Six in 10 Europeans report looking for health information on the internet, and most report that they can reliably distinguish between high- and low-quality information online, though the variability of information presented on the internet suggests that some patients may be getting misinformation.

Having a single portal for digital information provided at the EU level would create a useful place for patients to gain high-quality information, and online formats would provide greater access for patients for whom paper-based leaflets are inappropriate, such as people with low vision or blindness.

César Hernández García, PhD, head of the Spanish department of medicines for human use, explained efforts currently ongoing to develop useful patient guides. In Spain, efforts are underway to provide videos that can be linked to specific products, and images may show packaging and devices used to deliver medicines. Patients can flag products online and be informed of important updates to the medicines they use.

Finally, Fakhredin Sayed Tabatabaei, MD, PhD, senior pharmacovigilance assessor on the Medicines Evaluation Board of the Netherlands, provided an update on efforts to coordinate an EU-wide electronic patient information system (ePI). Said Tabatabaei, the ePI will go further than simply putting information online; it will include structured elements so that individual changes can be made and propagated to other stakeholders automatically using a dynamic database.