Drug Supply Chain: Interoperability Yesterday, Today and Tomorrow
Interoperability, the term which currently reigning the pharma supply chain, is shrouded by an air of mysticism even since the United States realized the need for some sort of a serial code or a bar code to authenticate products in a supply chain. It is still a myth now as to how two completely different systems can communicate with each other.
On second thoughts, it has always been possible and the solution was at hand, right in front of us, only we didn’t realize.
From the Wal-Mart days
The journey we have crossed to be where we are today was never easy because innovation came with experience every time there was a need to design a system that could help in verifying and authenticating the products. Observation and intuition hardly had a place for in a versatile ecosystem like that of a supply chain.
Take the instance of Wal-Mart RFID. The need for any form of verification was first realized by Wal-Mart even before the federal serialization mandates and the California e-pedigree act came into place. In 2003, Wal-Mart issued a mandate to all its 100 suppliers to attach a passive ultra-high frequency RFID tag to each case and pallet for all products to be shipped. As simple as it may sound, the Wal-Mart dictate proved to be a genesis for all the traceability guidance we are following today- the effects it had on the suppliers then and the drug supply chain stakeholders now being the same.
While we say that, the past beyond that is non-negotiable. The PML standards prior to the RFID were constructed to bring in a system of interoperability or communication between different stakeholders in a business. However, it was not sufficient to meet the demands of the supply chain, much as foresight for an industry that is ever-changing and dynamic. Leaders then had then realized (and continued to do so) that there had to be a standardized way that stakeholders had to be aligned to be able to handle volumes of consignments accurately and fast.
[Read about the future of scanning technology]
EPCIS is not a present-day concept
EPCIS or data communication could become a norm only when there was a standard flow of operations. Thus, the EPCglobal group was formed with GS1 to develop and maintain a group of interoperability standards for an RFID-based ecosystem. This became the genesis for the Electronic Product Code Information Services Standard (EPCIS) along with other lesser-known standards. Eventually, the Wal-Mart RFID and the EPCIS were later cancelled out with newer standards that were more accurate and fast. Moreover, with increasing demands for a better barcoding system, the EPCIS system gradually became a mere fundamental concept rather than a practice.
Another reason why EPCIS was not accepted as a standard format of data-sharing between stakeholders were required to exclusively use GS1 barcode symbology and encoding, while EPCIS could read-only Uniform Resource Name (URN) format along with Instance Lot Master Data (ILMD) which were difficult to syn in with the evolving systems. Again to arrive at a well-formed EPCIS URN, certain values in the barcode were needed to be dropped, repositioned or reshuffled, making the end-result unrecognizable to both machines and humans, making the entire system repetitive and redundant, not to say time and capital-consuming.
Another reason why RFID-origin URNs could not continue to be in the drug supply chain communication system is because of the RFID readers reported tag data as long hexadecimal numeric values, making any GS1 data such as SSCC and GTIN embedded on an RFID tag completely unrecognizable to the human eye and also unsuitable for certain types of machine logic.
EPCIS’s legacy did not end there and there were newer versions of the same such as EPCIS 1.1 and 1.2 that came with the changing GS1 standards, a version completely different from the initial EPCIS that became redundant at an earlier stage. In other words, there was a certain level of interoperability. However, there were challenges accompanied by the same.
- Challenges
The main issue with EPCIS- operated ecosystem is that it requires multiple connectors that handle vendor issues surrounding these standards. Due to the datedness of the system, the system fails to recover on its own, reducing the efficiency of the supply chain.
- Solutions
The solutions stemmed from the frustration stakeholders felt in implementing such labour-intense standards that were both time and capital consuming, without any expectation of an end result. Equipment that supported the EPCIS system and enhanced the end result were close at sight. With traceability solution providers like TrackTraceRX, which have designed multiscanners and cloud-based master database, the EPCIS has found a new role to play in the pharma supply chain.
Furthermore, the Pharmaceutical Distribution Security Alliance (PDSA), which is a group of more than 30 companies and trade associations, has proposed, an industry-run governance body to help standardize the future operability efforts.
After all, being interoperable could add speed to the supply chain, enabling participants to track and trace products increasing their visibility.
Breaking the glass ceiling
Interoperability has been a catalyst in speeding up a drug supply chain, especially because it enables transparent data-sharing between stakeholders that is necessary for DSCSA compliance. The aura of mysticism was never to stay because stakeholders would have realized its importance with time, especially when they would have encountered issues while communicating with stakeholders using other operational frameworks.
Interoperability, now, means a lot more than just grabbing information and storing for later use, it is also directly related to the way a supply chain behaves and the ROI it turns up. Interoperability means speed, accuracy, flexibility, security and business value- a holistic overlay that makes a system DSCSA-compliant and assuring drug integrity.
Interoperability in the present times
API-first approach: Interoperability does not stand alone, but is operational only with the support of advanced software and solutions that are based on the principles of the API-first approach. The best thing about this approach is solutions can be aligned with any framework without tampering with it. This makes communication between any stakeholder within a supply chain easier, transparent and faster. It must be remembered that the only way to make two disparate systems interoperable is to align them through an interface that is functional in both the frameworks.
AR-enabled multiscanners: Built with high-end technology like the RapidRX, these scanners unlike single scanners can read any kind of codes- 2D, linear, Datamatrix, enabling fewer negative verifications and more profit for businesses.
Blockchain technology: This technology is still being explored widely and is expected to play a key role in interoperability in drug traceability of the future. Blockchain technology, as the name implies, works in blocks, meaning data is stored in blocks in a cloud system, which is secured and expandible. Each block will have a key for individual players who can retrieve data by using that key.
Cloud-based master database: TrackTraceRX is already a step ahead in implementing the blockchain technology for drug traceability because it already has a cloud repository that interconnects stakeholders who are using its solutions. This helps in creating a connection with the manufacturers and other stakeholders at the VRS stage, enabling accurate authentication of drugs.
[Read: EDDS, 2023 DSCSA compliance and why we need to prepare from now!]
Further research is being carried out to enhance the abilities of the above-mentioned technologies and solutions so that the drug supply chain is future-ready. Most of the supply chain participants have already realized the importance of interoperability and are working toward implementing the same in their systems. This is because if systems can’t talk to each other, blind spots will be created, potentially allowing counterfeit medicine to sneak in.
