3. PharmaLedger’s ePI – Electronic Product Information Use Case

ePI – Electronic Product Information Use Case | Watch PharmaLedger’s Use Case presentation and topic-specific Q&A – and join us in our Trust-Centric Healthcare Journey.

The first PharmaLedger Open Webinar, “A Trust-Centric Healthcare Journey,” was hosted at the end of 2020. The topics covered consisted of the challenges, solutions and added value of four Supply Chain Use Cases. The webinar is available on the Pharmaledger YouTube channel if you have missed it – you can access each individual use case presentation and listen to questions answered by our presenters according to topic. The four Supply Chain Use Cases will be shared over the next couple of weeks so you can get up to speed with updates of our project and get ready for our next Open Webinar in February. 

ePI – Electronic Product Information Use Case

Following Finished Goods Traceability, the third use case covered in the webinar was ePI – Electronic Product Information, and it was presented by its co-leads: Patrick Maher (Novartis) and Ken Thursby (MSD). You can find this use case recording below, along with the Q&A related to this topic asked by the participants at the end of the video:

Here is a brief overview of the presentation, with minute markers to help you navigate the video recording.

Introduction to ePI (0:13)

Product information leaflets are found in every package and offer valuable information to both healthcare practitioners and patients such as information on the products ingredients, how to report adverse effects, how to take medicines safely, etc. These leaflets are closely regulated and require constant updates as the lifecycle of the product continues. There are many issues with the existing processes and usage of paper leaflets:

PharmaLedger aims to create a platform that would enable the switch from paper to digital by introducing ePI or Electronic Product Information leaflets into the healthcare value chain. While ePI itself is not a new idea, it’s promise has yet to be fully realised. The PharmaLedger goal is to leverage the clear advantages of blockchain technology to bring ePI to life. Some of the advantages are outlined in the image below. 

The Current Situation (2:44)

The following diagram depicts a high-level overview of the current process. The lifecycle of a paper product leaflet begins at the manufacturer or Marketing Authorization Holder (MAH) where the content is created. It is subsequently submitted to the health authorities for review and approval, and then again back to the manufacturer for printing, packaging, and dissemination in the form of a paper leaflet. The leaflets are updated throughout the products lifecycle, requiring this lengthy process to be repeated. 

While ePI is already being used in other industries, it has yet to be implemented in any meaningful way in the world of healthcare. When it comes to making the switch from paper to digital, we face the challenge of a huge paradigm shift. This shift is already in motion as health authorities and manufacturers are beginning to realise the benefits of ePI. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have established the so-called 10 guiding principles for the industry, as seen below. The next step is creating a digital solution in order to meet these principles, which is where PharmaLedger comes into the picture. 

Our Vision  (4:14) 

As of now, health authorities, manufacturers, and end-users throughout the healthcare ecosystem are operating in what is best described as a siloed manner. Using blockchain technology, PharmaLedger’s ePI Use Case aims to create a transactional infrastructure that would connect all players involved. 

The PharmaLedger vision has a Review and Approval component and a Dissemination component. 

  • The Review and Approval component enhances trust and brings efficiencies to the interactions between the health authorities and the pharmaceutical companies. The ultimate goal is to streamline the review and approval process in order to have the latest approved information made available to healthcare practitioners (HCP) and patients as the product information is updated throughout its life cycle.
  • The Dissemination component ensures that the patient or HCP only gets approved and trusted information in addition to built in anti-counterfeit checks, potential recall messages, etc. There is no need to have an individual app for each manufacturer, nor or an app for specific countries around the world. The ultimate goal is to allow the patient to have a solution that allows them to access all the required information for their medicines.

Connecting the Supply Chain Through the 2D DataMatrix (7:43)

The defacto standard for serialization is the GS1 Datamatrix code, which is used in the EU, US, and many other countries. With serialization, each pack has a unique number, and the Datamatrix code serves as a “digital key,” unlocking the connection across the healthcare value chain from the manufacturer, all the way to the patient. This digital key opens up the door to build on additional use cases, a huge stepping stone to meeting the ultimate goal of creating a trusted, transparent blockchain-enabled healthcare ecosystem.

Our Journey So Far (8:33)

The process of making ePI a reality began many years ago through various initiatives and excellent work that was performed and still is being performed today. Using the Pharmaledger ePI philosophy of “standing on the shoulders of Giants,” and using this as a foundational basis along with exploring the new possibilities offered by blockchain, the first prototype of the Pharmaledger platform was successfully developed in 2020. 

In 2021, Pharmaledger is preparing to continue development activities in addition to looking for collaboration opportunities in order to prepare for the launch of the ePI pilot that meets the needs of all stakeholders . A high level overview of the timelines is shown below. 

Stakeholders and Value Proposition (11:00)

There will be inevitable challenges and setbacks when making such a paradigm shift. However, by working closely with all stakeholders, keeping an open mind, having open and collaborative communication channels, and keeping the patient as the focal point, these challenges can and must be overcome. 

Closing Remarks (13:02)

The ePI Use Case from PharmaLedger aims to leverage blockchain technology to implement Electronic Product Information. This platform would optimise not only the process by which these leaflets are reviewed and approved, but their dissemination as well, thus creating an end-to-end solution for health authorities, manufacturers, and the end-user. Furthermore, implementation of this platform allows the ability to build on additional use cases, bringing more overall value to the healthcare ecosystem.

Q&A (13:46)

  • What’s the status of this project? When do they go-live, and is this only for the EU market or global? (13:50)
  • For the patient information: How would patients get information who are not using smartphones, tablet computers or other devices like this? (16:28)
  • Can we define/customize what information will be made available to the different parties? would imagine not all information will be relevant to all (19:11)
  • What is the greatest benefit of blockchain to a regulatory agency? (24:48)
  • I assume a big value could also be that the system would allow for more detailed pharmacovigilance. Correct? (31:03)
  • Another benefit of 2D matrix is – it’s already there due to serialisation! If other codes were added to the pack it will start to get very confusing for patients. (32:38)
  • What is the greatest benefit of blockchain to a regulatory agency? (35:35)?
  • Will this ePI system be effective for all the medicinal products within the EU or only for products registered via Centralised Procedure? (37:53)
  • To what extent is EPCIS, an open GS1 and ISO standard, used for the data model and capture/query interfaces, to ensure interoperability across all stakeholders? (38:43)
  • Is the plan to implement this in stages? What would be the first stage? Do you think it would be a good idea to try something simple like ePI only at first? (41:41)
  • Is the reason that we do not have ePI yet really that a platform such as blockchain is missing? Isn’t the problem much more on the open regulatory questions? (44:19)
  • Question on using blockchain use cases for ePI, what are the IT infrastructure that needs to be put in place in drug makers to enable the end to end workflow? (47:35)
  • Who is the ‘owner’ of the blockchain? (51:28)

If you’ve missed our webinar, you can watch the full “A Trust-Centric Healthcare Journey” webinar recording below, which includes the other three supply chain use cases. You can also look forward to a future article that will answer any unanswered questions that have been asked during the webinar. The next edited webinar recording will cover the Anti-Counterfeiting Use Case.

PharmaLedger has eight use cases in total covering supply chains, clinical trials and health data. PharmaLedger is a three-year project sponsored by the Innovative Medicines Initiative (IMI) and European Federation of Pharmaceutical Industries and Associations (efpia) that brings together a consortium made up of 29 partners who are working together to build a trusted platform using blockchain technology and in addition create many healthcare applications. 

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