Note: An extended version of this article originally appeared in the European Pharmaceutical Review.
All distributor eyes are on November 27, 2019, the deadline to have in place a process for verifying the unique product identification of returned drugs with drug manufacturers. This is a DSCSA requirement, of course, but it’s also lofty goal for the entire pharma industry: to ensure that counterfeit, recalled, suspect, or expired medicines don’t fall back into the supply chain after leaving a warehouse or dispenser’s shelf. Ultimately, the rule protects patients and businesses, acting as a safeguard against bad drugs ending up back on shelf as safe products.
Barcodes Have Improved, but Not Enough
LSPediA’s most recent warehouse study found that 23% of all 2D barcodes has coding issues. That rate is too high to be sustained when you consider the time and money it takes to manually investigate and verify those failures. Yet it’s a significant improvement on the results of a 2018 barcode study conducted by GS1 which found that only 6.6 percent of 2D barcodes with all four required data elements could be correctly read – meaning 93.4 percent of the verifications conducted were negative.
Still, a 23 percent failure rate with less than half a year to go before the deadline to verify saleable returns should be a major concern for everyone in the drug supply chain. Handling saleable returns is already a costly and time-consuming activity, but failed barcodes will mean that a substantial amount of returned product will need to be manually verified with manufacturers before those drugs can be resold.
The Cost of Negative Verifications of Saleable Returns
Once a scan identifies a suspect product, or a distributor is notified that a product in their possession is suspect, the DSCSA requires the following:
- Quarantine the suspect product
- Retain suspect product samples
- Conduct investigations with trading partners
- File an FDA 3911 notice
- Maintain a complete history of the investigation for six years.
There are an estimated 1.13 million units returned every week across the industry – or 226,000 units every day. If 23% bear faulty barcodes, 51,980 questionable items will need to be investigated every day. This equates to an average of 100 investigations for each U.S. distributor.
Investigate and Manage Exceptions with LSPediA’s VRS OneScan Solution
While barcode technology is getting better, the failures are coded in the existing inventory. As long as these inventories are in the supply chain, they must be addressed properly. Hence the critical need for a solution that can investigate and manage exceptions in order to rescue good products and investigate suspect products. LSPediA has that solution—the only VRS solution that addresses the nuances of negative verifications with a timely and pragmatic manner—OneScan® with Investigator® module.
OneScan categorically identifies negative verifications and alerts the corresponding manufacturer in real time. In turn, the manufacturer can enable verification by resolving the faulty barcode issue or confirming a need to quarantine suspect products. Other VRS solutions require manufacturers to perform this anomaly identification manually. Alternative solutions like hiring support organizations or offering self-service have proven to be impractical and not up to the task, as well as unscalable and inefficient.