The Drug Supply Chain Security Act remains a pressing topic for pharmacies across the country, as competing and sometimes conflicting messages – not all of them from reliable sources, and often spread by unscrupulous vendors – have surged through the industry. At LSPedia, we’ve been working tirelessly to set the record straight on the one-year stabilization period that starts on November 27, 2023, with statements straight from the FDA and long-serving, trusted industry experts. This week, we’d like to draw your attention to Benjamin Jolley’s Substack “Ramblings of a pharmacist,” which addresses the FDA’s recent guidance in a must-read post.
Jolley makes some sharp points about industry uptake of EPCIS 1.2, and even tackles misinformation around whether wholesale distributors can handle DSCSA compliance for dispensers who work with them via a portal for data exchange. (They cannot, and such an attempt would be both dangerous from a regulatory perspective and disadvantageous to the pharmacy from a business perspective. These portals are extremely helpful and should be used – but their usage meets the distributor’s DSCSA compliance requirements, not the dispenser’s.)
The post contains an excellent section for pharmacy operators with actionable advice on DSCSA compliance, including obtaining a GLN (and getting around potential pitfalls in the process), selecting a vendor to handle EPCIS data, writing up SOPs for DSCSA compliance and order receiving, establishing EPCIS data connections to wholesalers via your vendor, and ensuring collaboration and information sharing between your pharmacy software vendor and your DSCSA solution vendor.
We’re honored to have Jolley’s recommendation for our pharmacy solution in this section:
“After doing multiple demos and attempting to use other vendor software (which I found unuseable), I’ll personally be using LSPedia’s solution - they appear to me to be the only vendor with certain functionalities built as of the time of writing, such as connection to the Verification Routing Service (VRS) so that I can quickly conduct verifications of suspect product and clear it without the need for manual verification requests to pharmaceutical manufacturers.”
Jolley goes on to assert that “had the EDDS been fully implemented, and provided with a VRS connection, Shane Jerominski could have discovered the fraud by Safe Chain Solutions (LSPedia note: read about it here!) almost immediately upon receipt of the fake Genvoya, rather than having to call Gilead and wait for a response. He could have scanned the 2D barcode on any of the bottles and would have received a ‘duplicate serial number’ response from the VRS, which would have caused immediate quarantine of the product, rather than dispensing product that externally appeared legitimate and only discovering the fraud when a patient complained.”
Our work on OneScan Pharmacy Pro, and its readiness for use at pharmacies across the U.S., aligns with the FDA’s goals for the stabilization period: pharmacies can have all systems compliant now, to ensure that they can spend the following year (from November 27, 2023) perfecting intake and investigation of EPCIS files, fixing operational errors before they can interrupt business, and getting all staff fully trained on DSCSA-compliant procedures.
The post concludes with two more important points. Jolley emphasizes the likelihood that “it will be a best practice to scan 2D barcodes while dispensing, to record the lot/expiry/serial numbers used, and to integrate that data with the EPCIS received inventory data,” noting that the process is no more laborious than scanning 1D barcodes for dispensing, and has the added benefits of alerting staff to expiring product for more efficient management, and enables targeted handling of recalled products.
Finally, Jolley states clearly – and in line with the conclusions of every expert on DSCSA – that the best route for pharmacies is to be proactive on DSCSA compliance rather than wait any longer: “Let’s all get to work as an industry to make sure that we aren’t desperate for another delay next year.”
Pharmacies who need help getting started with DSCSA have never had an easier option – OneScan Pharmacy Pro enables pharmacies to easily meet all current and future provisions, and its features improve business operations beyond compliance. Get Pharmacy Pro now.
.svg){kind=icon}
