Beyond Saleable Returns: The Benefit of VRS Systems

pharmacist scanning a pharmaceutical product

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What is a VRS System, and What Value Does it Provide?

Under the Drug Supply Chain Security Act (DSCSA), US pharmaceutical trading partners are required to verify the Product Identifier (PID) of a pharmaceutical product when items are suspect or considered for saleable returns. To deploy a widely available (and highly responsive) product verification system into a disparate and decentralized ecosystem, the solution providers in the United States forged a Verification Router Service (VRS) network, an atypical cooperative and collaborative alliance among competitors.

VRS systems simplify and streamline the product authentication process, allowing trading partners, whether purchasing the goods directly or indirectly, to check and verify product-specific information with ease. Product verification requires an exact match of trade item identifier, packaging lot, product expiration date, and item-specific serial number. The product manufacturer executes the verification response, confirming the unique information assigned to a specific product carton or homogenous container.

The VRS system makes it quick and easy to confirm product legitimacy for authorized trade partners at any point in the supply chain. Additionally, when product expires or adverse events such as stolen, illegitimate or recalled product occurs, VRS can instantly notify the requestor and stop product from being further distributed.

While VRS systems are often recognized for their ability to verify saleable returns, VRS systems support a variety of additional functions that help keep supply chains safe:

Authentication of trade partners amidst product shortages, allowing more flexibility in finding safe supplies of drugs in times of need.

The immediate confirmation of the type, location, and quantity of product, regardless of who possesses the product at the time of inquiry.

The easy and prompt identification of potential counterfeits in the supply chain, as demonstrated by the Arkansas Board of Pharmacy with Ozempic.

A successful VRS network requires a common PID lookup directory, and the collaboration of many different solution providers who typically rely on self-testing and self-reporting to comply with product verification requirements. Regardless, the added benefits clearly demonstrate that VRS systems make this cooperative effort worthwhile.

Given the complexities of pharmaceutical supply chains today and the risks of counterfeiting, traditional means of verification simply aren’t enough. While industry has stressed traceability, VRS systems provide an extra layer of security by allowing trade partners to instantly verify pharmaceutical authenticity.

Gateway Checker: VRS Verify™

Just as important as having a VRS System enabled is ensuring the system is appropriately configured and performing to both application standards and industry expectations. The Gateway Checker VRS Verify™ testing module independently tests systems, validating responses externally to a drug supplier’s system environment. With VRS Verify™, you and your trading partners can be confident that your system functions as intended and meets strict industry requirements.

VRS Verify™:

●      Ensures the VRS system produces accurate and timely responses to verification requests

●      Automatically generates and executes VRS validation test queries

●      Confirms the VRS system meets user and industry requirements

●      Generates documentary evidence of successful testing

Successful VRS tests are eligible to become Gateway Certified™, the only independent product VRS testing service available. Gateway Checker™ is the US Pharmaceuticals industry leading GS1 Certified Conformance Testing Service.

To learn more about VRS Verify™, and for a complimentary product verification assessment, visit this page.


Coming Up Next: “Who Needs Drug Product Verification and Why?”

 

Verification Router Services: A Solution to Drug Shortages? 

The Importance of Collaboration to Address Drug Shortages

On October 31st, 2024, I listened to a compelling LinkedIn conversation hosted by Chip Davis of the Healthcare Distribution Alliance, titled “Working Collaboratively to End Drug Shortages.” Joined by Laura Bray of Angels for Change and April Gile of the End Drug Shortages Alliance (EDSA), the panelists emphasized the crucial role of collaboration in addressing the issue of drug shortages. Both of their organizations have taken tremendous strides in addressing the issue of drug shortages, an issue adversely impacting millions of Americans every single year. 

When organizations work as individuals, rather than cooperating, little is accomplished to address the drug shortage crisis. In the conversation, Bray stressed “I have so many examples of times where 3 people in a room did way more than 30 individual organizations trying to solve [the drug shortage crisis]. 30 people in a room working to the same goal can truly solve the crisis and save lives.” The complexity of supply chains and other communication barriers make cooperation more difficult; however, its organizations like theirs that are helping make this process easier. 

To address shortages, we must bring together supply chain partners who typically don’t interact with each other. As April highlighted in the conversation, transparency and proactiveness are the keys to success. She noted: 

“How do we identify shortage risks in a preventive way, ahead of a shortage vs. behind it? How do we think about promoting transparency between these partners who have really never worked (together) before around inventory awareness, and really create an effective collaboration approach to prevent disruptions ahead of time vs. being responsive after a disruption occurs.”  

Pharmaceutical partners must invest in systems and processes that encourage greater transparency across the supply chain; one of these solutions is product verification through the Verification Router Service (VRS). 

Could VRS Help Solve the Problem?

Though most understand VRS as a means to handle saleable returns, product verification through VRS could provide other benefits. VRS can help proactively address drug shortages in a variety of ways, assuming supply chain partners verify product both at the time of order receipt and delivery.  By identifying replenishment rates to better address supply and demand, authenticating sources to prevent improper disposals, and providing up-to-date product information to support inventory turnover, there is a major role VRS can play in addressing shortages. 

Traceability is currently limited to a one-up, one-back system, where partners only track drugs one partner before (direct supplier) and one partner after them (direct buyer). However, as drugs make their way from manufacturers to end consumers, there are usually 4-5 stops they make along the way; these stops include wholesalers, distributors, third-party logistic providers, and/or other partners. It’s clear to see how supply chain visibility and transparency can be limited from start to finish; product verification through VRS systems, if used effectively, can help address the drug shortage crisis. 

The challenge? Making VRS data available for every supply chain partner. Currently, VRS data goes directly back to the manufacturer. However, in consideration of the role VRS could play in proactively addressing the drug shortage issue, could we consider making the data available to all supply chain partners? Could centralizing this data for analysis address the root cause of drug shortages better than current methods? While industry partners would need to collaborate extensively for this to work, the added transparency and visibility integral to resolving the drug shortage crisis would make it well worth it. 

What do you think? Do you see a future where VRS helps prevent and resolve drug shortages?  

VRS System Verification at HDA 2020 Traceability Seminar

As you know, the FDA recently extended saleable returns verification until 2023.

Please join Gateway Checker CEO and Founder Gary Lerner at the HDA 2020 Virtual Traceability Seminar where he is hosting a VRS System Verification roundtable on Tuesday, November 3 at 10:00 AM ET.

We will address the FDA’s saleable returns verification extension and have a lively discussion on data integrity challenges facing drug manufacturers, wholesalers, and dispensers as the deadline extends out to 2023.

During the session we will address a key industry question:
How are pharmaceutical manufacturers, distributors, and dispensers viewing the need to establish, test, and deploy VRS given the extended FDA enforcement discretion for saleable returns verification?

Topics for discussion:
What are your plans for VRS given the recent FDA announcement?
What factors are driving your decision?
What actions would you like to see from the VRS solution providers?

If there are additional topics you’d like us to cover, please contact us.

Click here to register.