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Top Five Questions Asked at “Making ePI a Reality: The User Journey” Webinar (Session 1)

Read on for a recap of the top five questions asked by webinar attendees and their answers provided by PharmaLedger partners and invited guests.

This past November, we hosted the first session of our third open webinar and live Q&A, “Making ePI a Reality: The User Journey.” This webinar focuses on Electronic Product Information (ePI) and examines the history, evolution and future state of this use case, including feedback from patients joining as guest speakers to share their feedback on the application. 

Following the presentations, attendees were encouraged to submit their questions around ePI, blockchain and healthcare, and the PharmaLedger project. Attendees also had the opportunity to vote on the questions being submitted, which determined which questions the speakers answered first. Below you will find the top five voted questions attendees asked during the first session of “Making ePI a Reality: The User Journey.” 

Top Five Questions Asked – Making ePI a Reality

The questions that were voted on the most were answered by ePI use case co-leads Patrick Maher (Novartis) and Ken Thursby (MSD). You can read the speakers’ responses below.

Question 1. Do you have support from the European Medicines Agency (EMA) to remove paper leaflets in Europe?

Patrick: Pharmaledger is building a platform that will potentially allow the removal of the paper in the future. There are many aspects to the removal of the paper in the 10 Key Principal Issue from European Medicines Agency (EMA), although paper leaflets will remain for the time being. We hope that with PharmaLedger’s proven trusted platform, this will change.

Ken: The EMA is doing a lot of work around the eLeaflet. Some nations in the EU 27 are moving ahead of EMA and have applied for a European commissioned derogation to remove paper in pilots and in hospital products. This allows for the ecosystem to learn on a smaller scale the impact of removing the paper. We heard from patients that the information on the paper is valued and we can’t restrict access to the information on the pack. This doesn’t mean it, however, that has to be in the box. You have to go through a certain journey to show the positives versus negatives that are reflected in the EMA principles.

Question 2. Some companies have their own ePI project already implemented. What’s the plan to have all pharma companies onboard on the same project like Pharmaledger? 

Patrick: We need an industry approach to this, but is useful that companies are starting their own ePI projects. We need to see what is best for the ecosystem and how we can manage to do this. There could be very many different solutions out there, which we are mindful of. We will encourage others to consider and look at the PharmaLedger solutions. We admit that we don’t have all the answers to all the questions out there and we are at the start of this journey. We will need engagement with others in the other stakeholder groups.

Question 3. When could we actually stop putting leaflets into boxes? Even if eLeaflet is fully functional, paper leaflets would be mandatory for patients not using mobile devices.

Ken: We have seen some markets around the world where eLeaflets are allowed, such as in Australia, Singapore and soon Japan. Some markets are moving faster than others. When it will exactly happen is a great question. There is global environmental pressure around the world to tackle climate change. The paper and print industry is the most energy-intensive industry. The leaflet is a small part of the packaging, but it would be the right step in the right direction to reduce the energy cost of this. 

Question 4. When do you expect this to come to market?

Patrick: We are planning on having production-ready at the end of next year, so around the start of 2023. There are many aspects to fulfil to get it to the market.

Question 5. What Extensible Markup Language (XML) standards as leaflet details (like HL7 SPL) are supported by PharmaLedger? 

Patrick: Right now we are using SPL from the United States and we are aware of what EMA is doing. We do have this situation where we have a lot of word documents and PDFs, and the question is, how can we convert them to an XML structure? Using just one standard would be ideal, but highly unlikely. We will continue keeping an eye out on these standards.


Do you have questions of your own? We want to hear them! Register below to join us for the second session of the Open Webinar and live Q&A “Making ePI a Reality: The User Journey” on the 11th of January, 2022. 


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