Things that you should look for in your VRS provider
As the deadline for VRS compliance on 27th November approaches, pharmaceutical warehouses are increasingly concerned about their compliance status and whether or not they would qualify the VRS audit that takes into account everything from the equipment that is being used to perform verification of saleable returns to the methodology being used to purge the fake and the spurious; How the entire process is being documented and how much time the warehouse takes to inform the FDA about the steps it has been following to complete the saleable return process.
Just striking off the requirements, once you achieve them, is not enough, you have to check if the system you have put in place is proving to be profitable on an overall basis by reducing the negative verification (which amounts to billions of dollars annually); And the service provider who is working toward the compliance is following certain critical steps to ensure that you get the desired outcome.
That is possible only when you know you have hired the right VRS provider.
What is a VRS provider expected to do?
It is noteworthy here that approximately 2–3% of total pharmaceutical sales are saleable returns. The numbers can largely stretch for large pharmaceutical distribution centers. However, due to the lack of integration of advanced machinery, warehouse officials fail to identify products with 2D barcodes that can be easily returned to the market. Simply put, for large pharma distribution centers, the numbers of return units per day could stretch to tens or tens and thousands of units of return saleables. Handling that volume while sorting, repackaging and redistributing can be a humongous task, which can often lead to mistakes or erroneous procedures.
So, how can that be avoided? Getting a VRS provider who has the facility and infrastructure to perform the following is the only solution:
a. Accept Product Identifier (PI) information from an authorized Requestor via an interface or manual entry using a VRS portal: Requesting for details is an important part of verifying returns. This requires dispensers and distributors to raise a request from the manufacturer whether or not he has produced the drug. The VRS portal should be able to connect to the requested FDA labeler and communicate with the manufacturer, notifying him of a ‘suspected’ product. The manufacturer can respond immediately with the request, saving crucial time.
b. Determine the routing location to where the verification request will be submitted based on the Global Company Prefix (GCP) or Global Trade Item Number (GTIN) provided by Requestor and master data from Responder: Sending the right request to the right stakeholder not only improves the speed of the VRS process, it also ensures that an accurate response is obtained. The VRS provider should be able to connect the GCP or the GTIN to the related manufacturer for the appropriate response.
c. Format and send the verification request to Responder’s system directly or to a VRS used by the Responder: Data-sharing is an important part of the drug supply chain, especially when it comes to VRS. Requesting or receiving the right format of information can streamline the drug supply chain and also save crucial time. The standard communication format provided by DSCSA is applied by the VRS partner to communicate the requests and their responses to different stakeholders.
d. Provide an electronic record/audit trail capability: The VRS partner should have a mobile-edge platform that can track the whereabouts of a product unit from the verification ‘request’ stage to the ‘response’ stage. The platform should also enable the handler to decide on the next action, depending on the request response, to curate, repackage or destroy the product before finalizing on the resalable list. The platform will also help the wholesaler in filling up the 23-pager FDA 3911 notice for every illegal case that needs ‘destruction’. It is noteworthy that the audit form for each action should be intimated to the FDA within a span of 24 hours. Addressing thousands of such illegal returns could be a tedious job when it comes to identifying and then reporting them to the FDA. This is where technology improves the situation. While multiscanners can already speed up the end-to-end drug identification process, Augmented Reality (AR)-enabled vision-powered multiscanners go a step ahead in the real-time product verifications of the saleable or non-saleable returns.
The FDA expects these systems and procedures to be incorporated into existing SOPs, or in new SOPs, and specifically approves the use of a secure electronic database as described in the DSCSA.
Summarizing the contributions of VRS providers
Check if:
· It is following the API-first approach to be able to seamlessly patch up new software in the existing operational framework of the requester and the responder.
· It connects seamlessly with the look-up directory
· It has the right systems to determine a product is suspect
· It has a system for suspect product quarantine and investigation
· It has a system for cleared product notification regarding suspect products
· It has a system for illegitimate product quarantine and disposition
· It has a system for illegitimate/high-risk of illegitimacy product notifications
· It has a system for responding to requests for verification
· It has a system for processing saleable returns
· It has the right technology to counter the issues that arise of VRS implementation
Traceability suits having the above-mentioned features can add great value to any VRS system. From request sent to the response received, the suite is able to manage every step of the VRS process efficiently, notifying and recording data at every stage, thus refurbishing the FDA audit form at a later stage. From consignment management to destruction (when deemed fit), the suit guides and informs the warehouse professional in the VRS process about the status of the product and helps in effective line management. Connecting to the Loo-up directory or the E-directory, which helps in identifying a unit is something that VRS providers should not miss out on. And checking if they have the right equipment for the sane is something that should not be ignored by the client side.
The VRS process requires a lot of experience and expertise, which should be one of the key pre-requisites for selecting VRS partner. The checklist that we have provided strictly follow the guidelines set by DSCSA and FDA. Following the pointers will certainly land you up with the right stakeholders.
