Last year the Food and Drug Administration mandated new verification requirements for the drug supply chain, as part of the Drug Supply Chain Security Act (DSCSA). As the DSCSA verification requirements come ever closer, many different methods of handling verification requirements are being analyzed by the pharmaceutical industry.
Methods such as maintaining a central repository that aggregates all relevant data, providing each manufacturer with their own verification database, and having distributors scan outbound products have all been suggested. Not all suggested verification systems suggested are created equal though, and one system stands out as being more workable than the others.
At the end of last year, the Healthcare Distribution Alliance (HDA) completed an analysis of nine potential ways to ensure drug companies meet verification requirements. The HDA then held a workshop where they presented pilot versions of two of the most promising verification systems.
One approach was to have manufacturers aggregate product identifying information and send it to individual distributors, when the distributor needs to process a saleable return they simply reference an internal database to verify the identifier information. The other tactic discussed for was the use of a verification router service (VRS), where a third-party routing service stores all product identifier data locally.
VRS has the potential to make meeting verification requirements easy and convenient, regardless of how many companies it has to serve.
What Is Verification Router Service?
As defined by the HDA, verification router service refers to using a third-party routing system to send product information back and forth between distributors and manufacturers.
“The manufacturer stores all of its product identifier information locally, which is connected to a third-party routing service. Upon receiving a saleable return, the distributor captures the product data and sends the data to this third-party router service, which then routes the query to the appropriate manufacturer’s database,” reads the HDA communication.
How Is Verification Router Service Structured?
HDA’s workshop on VRS did not specify a structure the VRS system would have, but it did provide an example of how a VRS system might operate.
The pilot example shared by the HDA consisted of five different steps, and was anchored by a GTIN-to-IP address table. A manufacturer would have to share their EPCIS repository IP address, as well as their GTINs (Global Trade Item Number), in order for the pilot VRS to function.
HDA’s proposed 5-step process is as follows:
- Step 1. A wholesale distributor receives a saleable return. They then scan the DSCSA product identifier on either the whole case or the first unit, and acquire the serial number and GTIN for the product.
- Step 2. The wholesale distributor sends both the serial number and the GTIN to the VRS. The VRS will then utilize the GTIN to look up the manufacturer’s EPCIS IP address.
- Step 3. The VRS sends the serial number and GTIN over to the EPCIS for the purposes of verification.
- Step 4. The manufacturer’s system responds to the request with the corresponding serial number and GTIN, or with the current status of the units in question.
- Step 5. The VRS system sends the relevant information to the wholesale distributor who needs it for saleable returns purposes.
This is only one possible way that a VRS system could function. In a webinar from another organization, an alternate system was proposed, which would see the VRS just providing a wholesale distributor with the EPCIS IP address, which would let them directly communicate with a manufacturer.
This is a less complex method of communication, rather than having the VRS itself communicate with the manufacturer’s EPCIS.
Fewer variables involved in the communication process means better performance, security, and scalability. If the direct communication method were to be used, it is likely that both wholesale distributors and manufacturers would need to employ a web service layer that enables the VRS communications.
What Are the Challenges of Verification Router Service?
At the HDA workshop three major challenges were identified that must be overcome by a router service.
The first issue is that collaborating and communicating on a task is difficult in an environment that has many different organizations. There are logistical problems that inevitably arise when dealing with large amounts of people, and beyond that different companies in the supply chain will want to have their own frameworks in place that benefit them, meaning negotiation between companies might prove difficult.
The second challenge is that any issues with downtime, outages, or system connectivity issues must be dealt with in a timely and efficient manner. Any delays in the processing of one packet of information will have ripple effects and become amplified due to how interconnected the VRS system is. If a distributor cannot get information from a manufacturer in a timely manner, those who need the information from the distributor will also be inconvenienced.
There are also a variety of problems surrounding the proper scanning, encoding, and formatting of products and product information. It could be difficult to sync scanning equipment with VRS because of the inherent differences in the two forms of technology. A universal format for VRS related product information must also be established.
The pilot program was able to handle a verification request from a distributor to manufacturer in 0.7 seconds. It performed at sub-second speed, meaning that the program is probably able to handle requests in real world operating conditions, despite the fact that in 2019, operators will be required to scan a 2D matrix code before sending their verification request to a router service. This would further complicate the process, and if response times became longer than a second, the return transaction might cut off altogether.
The HDA decision to endorse verification router service as a possible solution to meeting verification requirements has implications for the entire industry. If VRS is successfully implemented, the transfer of verification data between wholesale distributors and manufacturers should be relatively painless and easy. For this to happen though, every company in the supply chain will have to collaborate in the creation of VRS.
Many different companies will be looking at the technology over the coming months and attempting to create their own VRS frameworks.
While settling on a specific framework could prove challenging, at least at the moment, despite all the complexities, VRS seems to present itself as a viable way to meet verification requirements.
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