BUILDING A DIGITAL TRUST ECOSYSTEM
FOR HEALTHCARE

Stakeholders want ePI. ePI enjoys widespread support from key ecosystem stakeholders including patients, HCPs (Health Care Providers), pharmacists, health authorities & governments, as well as industry. In short, stakeholders want ePI!

Creating Digital Value for patients. Our aspiration is to build a solution for patients that is valued by patients. Patients and HCPs have been involved in development and proof-of-concept testing of PLA’s product, with positive opinion received. The PLA product seeks to address the complex challenges in the ecosystem to make ePI a reality. We think by providing a better Product Information experience and providing utility through enhanced safety and security, we can catalyze the move to digital. It’s taking a step toward digitally-enabled healthcare in the future.

Meet unmet need. In the 3-year period of the Pharmaledger Project (Jan 2020 to Dec 2022), markets initiating ePI pilots quadrupled, currently at 47 markets world-wide! International healthcare companies have an unmet need. PLA aims to meet this unprecedented demand with a solution which supports scale, avoiding the complexity of developing and operating multiple national solutions. 

With healthcare companies each marketing several thousand finished good SKUs in these markets, complexity and cost of implementing ePI mounts significantly as more markets pilot ePI, then seek to scale. The current path of market-specific solutions is not ideal.

This is particularly important where shared packs are used – a package which is exactly the same but supplied to multiple markets. A common ePI solution is needed across all the shared markets using the shared pack, else the shared pack would need to be broken. To maintain the benefits of shared packs – like reducing shortages, reducing discards, and opening up access to products – simplifying to common standards supports both ePI and Shared Packs. 

PLA’s ePI product provides the patient or HCP with the latest approved version of the Product Information direct from the marketing authorization holder (MAH). In the paper leaflet world today, the MAH is responsible for the correct leaflet in the carton. We propose to keep this accountability, but electronically, avoiding the need (and costs) for an intermediary to manage it centrally. 

When ePI’s are updated in the MAH Systems of Record, the latest leaflet is pushed to the solution so the user always gets the latest ePI.

The ePI is accessible through a scan of the barcode on the product package. The scan reads the “GTIN” or Global Trade Identification Number and the batch and uses blockchain as a resolver to determine the correct MAH of the product. The latest approved version of the Product Information is then provided to the user. 

The barcode on the product can also provide additional information, such as the validity of the expiry date and serial number. These can also be checked to verify the product packaging.

An important aspect is that no patient or user information is captured. The patient’s use of the app to identify the product and access the information is private. The product owner will not have any scan information to identify the user in any way, as this is private.

In the future, the unique identification of the product offers a host of potential services to the patient, depending on user consent: 

–        Notification if the Product Information is updated

–        Notification if the product batch is recalled

–        Additional checks on the authenticity of the package (serial number, product status or even authentication features on the package)

–        Drug interaction issues with other scanned medicines (in a virtual medicine cabinet)

–        Adherence reminders created with a link to the prescription

–        Proper disposal instructions of excess medicine based on the expiry date

–        Adverse event reporting

–        Adding specific medicine information to the patient’s electronic health record (EHR)

–        Video media

–        And many more to come!

Currently there is not a great deal of alignment among health authorities as to the best approach, nor within the industry, or sometimes even the same company! So what to do about it? 

The current situation is that there are 47 markets experimenting with national solutions, all with different technology approaches. This adds complexity and cost to develop and operate. It also does not work with shared pack markets (different countries using a common pack). PLA offers a solution which seeks to leverage standards and a common approach to enable ePI at scale, globally. There is no other solution that offers this today. We are seeking collaboration to do this, as an industry and with patient engagement. If companies do not take a stand now, then they are going down the path of national pilots, with the added complexity, cost and scale-limitation that comes with it.

We accept that one standard for the world is not possible, and exceptions will happen. But we have a unique opportunity to standardize and optimize ahead of growth.

PLA members are invited to provide their input and leverage their experience in the evolving ePI world to develop the solution further, as standards emerge and legislation develops.

The solution is designed and built to quality assurance standards, to provide a compliant, reliable and trustworthy ePI – to the same high standards the healthcare industry has with the paper leaflets. This is an essential enabler for us to make the paradigm shift from paper as the ‘primary’ product information to electronic as the ‘primary’ and the ultimate replacement of paper inserts.

Other compliance requirements come into play when we transition to digital, including Privacy, Data Protection, Accessibility and Pharmacovigilance. We propose to solve for these once with one common solution and then implement it to multiple markets.

The ePI product from Pharmaledger is only one part of the end-to-end process a MAH (Marketing Authorization Holder) would need for compliant, scaleable ePI. PLA partners would also need to work to develop their internal business processes to ensure the ‘Right ePI’ for the ‘Right Product’ using the ‘Right Barcode’, at scale. Standards and a common approach support this.

The blockchain is only one ‘component’ of the PharmaLedger ePI solution. Like any technology solution, there is a technology stack: the platform, the middleware and the user app. The power of the solution is the combination of the stack technologies working together.

The blockchain acts as a ‘Connector’ and a ‘Resolver’ to match the ‘Right ePI’ to the ‘Right Barcode’ for the ‘Right Product’. It is the platform part of the technology stack.

The blockchain resolver is connected to a network of ‘Enterprise Wallets’. Each pharmaceutical company will have an Enterprise Wallet to store their ePI documents. This is manually managed in the first release, but designed to be fully automated and linked to the company back-end Systems of Record for scalability. This is the middleware.

The Patient or HCP will use the app to access the ePI. PharmaLedger has built one for the first release, but could easily be adapted to use a national app or 3rd party app by connecting it to the Enterprise Wallet.

The three parts of the Technology Stack, the Blockchain Resolver + Enterprise Wallet Network + App, work together to give the ‘Right ePI’ for the ‘Right Barcode’ for the ‘Right Product’.

As with any system, there is no perfect solution, or one without challenges. We propose a scalable solution which is country agnostic, privacy preserving, open to any manufacturer, without a single point of failure, uses standards, reduces complexity and gives value to the patient. 

Approximately 90% of Rx packs by volume have serialization barcodes on the package. The Data Matrix barcode is the industry de facto standard (it exists today) and it uniquely identifies every pack down to batch and serial number. Can we use this barcode for ePI? The answer is yes!

The Data Matrix holds data which can provide ePI plus other valuable services to enhance safety, security and support digital health transformation.

Manufacturers already have invested in assets and quality control processes to ensure that the correct barcode is on the correct package, linked to master data. This is a valuable enabler for scaling. Ideally, we don’t want to add another one!

PLA uses the Data Matrix as the ‘digital key’ in our solution through an app which can read and resolve the Data Matrix barcode to the correct leaflet.

That is not to say QR codes do not have a role. QR codes have become very popular across the world for accessing a website. We offer a web app for users, which can be accessed using a QR code without the need to download an app from Google Play or the App Store. This lowers the barrier to accessibility while also taking the advantages of the serialization barcode.

The Pharmaledger App can also scan a wide variety of barcodes including EAN/UPC identifiers that could work for non-prescription pharmaceutical products in the future, which would benefit the patient.

The strategy, as with any new technology approach, is to build trust and convenience into the digital solution. 

1. The first step is to present the concept and demonstrate the functionality to key stakeholders. This has been done during the course of the project on several occasions. 
2. The next step is a productive pilot of the qualified solution in an operational environment. This proves that the solution works reliably as designed and is acceptable to the users in terms of functionality, performance and ease of use. Based on the feedback, the solution can be improved to address local requirements and user feedback. 
3. The last step is productive implementation, which could be phased by brands, geography, specific hospitals or pharmacies, or other criteria.

At all steps, there must be a campaign for general awareness and adoption. This is initially driven by PLA, and then jointly driven by PLA and health authorities. The goal in the end is that the doctor, who is the ultimate source of trust to patients, will confidently recommend the app to their patients. 

When ePI is established as a stable, proven solution in one or more markets, adoption can be streamlined by jumping directly to Step 3, but the general awareness and information campaign is always required. 

PharmaLedger relies on the GS1 DataMatrix as a data carrier to identify unique medicine products in its electronic Product Information (ePI) and Detecting Falsified Medicines solutions. Currently, identifying products and accessing product information by scanning the DataMatrix requires a special app, since the code is not yet recognized by the standard smartphone cameras which automatically recognize QR codes. Although QR codes are popular for convenience-oriented applications, we believe there are several reasons to support the broadest possible adoption of GS1 DataMatrix as the only barcode for medicinal product identification in healthcare:

• The GS1 DataMatrix is the recommended barcode for medicine identification and is mandated by regulation in most markets that require serialization and traceability, and for new markets which plan to implement such regulations.
• The GS1 DataMatrix must be present on the secondary pack in these markets. Adding an additional barcode can create confusion with patients and healthcare providers, at exactly the time when they require certainty about their medicine.
• The DataMatrix, containing the Global Trade Identification Number (GTIN), Batch, Serial Number, and expiry date, is designed to enable scanning even if damaged and provides the smallest artwork footprint on the package.
• We have examined security aspects in the Detecting Falsified Medicines use case and are convinced that the DataMatrix provides a higher level of security. Although both the QR and DataMatrix codes can easily be copied, we have successfully implemented additional checks in a demonstrator which increase user confidence in the product package authenticity. In addition to the serial number, these checks include validity of batch and expiry date, embedded security feature verification with the smartphone camera, and flagging of suspect product batches.
• The GS1 DataMatrix is a data carrier that can enable not only ePI and Detecting Falsified Medicines, but also many more future supply chain capabilities as depicted in the figure below.

In addition to new supply chain applications, we envision many digital services for patients made possible by a data carrier like the GS1 DataMatrix. These include recall notifications, adherence reminders, adverse event reporting, drug interaction alerts, and expired or excess drug disposal guidance. These services will increase patient safety and value, and help overcome the adoption challenge of a dedicated app requiring a download from an app store. PharmaLedger developed an open-source app for easy scan of DataMatrix barcodes with the help of patients who understand what’s possible using the data embedded in the barcode. Patients (and everyone) want to protect their privacy, and if a dedicated app can guarantee that in the future, then more education and awareness are required for broad adoption.

We refer to the GS1 Position Paper “The key role of GS1 DataMatrix barcodes for product identification in healthcare”, dated December 2021.

Patient engagement and empowerment are key themes of the PharmaLedger project. By achieving industry consensus on a single barcode, the GS1 DataMatrix, we can make a step forward toward achieving our overall objectives and benefiting patients.