Can DSCSA Really Help Keep Patients Safe?
If you follow pharmaceutical serialization laws around the world, you have likely seen all the press around the most recent case of Ozempic confirmed counterfeit product being discovered in the legitimate supply chain.
We find some recent comments on social media forums to be overly simplified in either stating that DSCSA will eventually stop counterfeiting or some who are saying that DSCSA is entirely ineffective and should be discarded. While we can't expect any law or system to be perfect and the US supply chain has a significant amount of work left to complete DSCSA implementations, it is also worth noting that it very clearly identified the product as counterfiet once action was taken and will provide critical evidence and statutes for holding criminal actions accountable.
The recent Vanity Fair article adds to the growing list of known cases the past couple of years:
https://www.vanityfair.com/news/story/counterfeit-ozempic-global-growth-industry
It remains true that the US pharmaceutical supply chain is among the safest in the world but this cannot allow us to become complacent in learning and applying lessons from the recent counterfeit cases. They have shown that bad actors understand the requirement of placing a scannable and human readable serial number on the box. Indications are that many are leveraging discarded packaging or reprinting known valid serial numbers. So what are some key lessons that we can learn as the industry completes the stabilization period of DSCSA and innovators look for ways to most importantly protect patients? We share some initial thoughts but also welcome more feedback. It is useful to highlight that advancing DSCSA compliance also means protecting your organizations brand as a manufacturer, packager, distributor or dispenser of safe medicines.
1. Know the FDA Guidance- All the noted cases above, showed instances where aspects of FDA guidance clearly call for the product to be considered suspect and required follow up actions taken. Anytime your organization (especially procurement) is dealing with a new supplier, a limited supply product, an unusually good deal, product with a difference in appearance, or any other FDA noted reasons you should take caution. We strongly encourage all trading partners to become familiar with DSCSA guidance, especially the guidance related to the identification of suspect product found here. Note that the FDA has an entire website dedicated to quickly finding the latest guidance documents in order from newest to oldest.
2. Authorized Trading Partner Checks- DSCSA, the related guidance documents as well as industry documentation make it clear that you should already be checking that any trading partner has proper licenses and registrations required at any federal or state level. While this may or may not have stopped recent cases of counterfeit product, it very clearly identifies who the parties are involved in any sale and what authority they are operating under. Companies are required to follow all federal and state laws in order to maintain good standing and are subject to disciplinary action including revocation of licenses, fines and possible jail time depending on any infraction.
3. Maintain Trading Partner Identifiers, Connection, and Contact Information- If any trading partner becomes suspicious of product or related transaction data they have received, they are required to work with direct trading partners, the related manufacturers, and/or regulator officials to quarantine, investigate, and disposition the involved product. In working through any exceptions, maintaining up to date identifier and contact information is key to avoid wasting time while investigating.
4. The Need for Interoperability- Serial numbers on boxes alone are only a starting point. For DSCSA to be more effective, stakeholders from across the industry need to understand the importance of receiving, storing and sharing the related transactional data. In the recent case of serial numbers being reused in bulk, any basic serialization system would have quickly rejected a file if it contained more than one of any valid GTIN-serial number combination. This would have been an immediate red flag for both the seller and receiver of the product in any ownership change transactions.
5. Importance of Product Verification With the Manufacturer- DSCSA outlines instances where trading partners must ensure the encoded GTIN (NDC), serial number, lot, and expiry date match original data the manufacturer created at time of packaging. While this requirement may be considered to be met through checking a barcode against historically sent EPCIS transaction data, the use of once legitimate product identifiers, highlighted in both EU and the US, a key differentiator is being able to verify real time with the manufacturer of record to understand if the manufacturer has any reason to believe the related product is unsafe. In this event, the manufacturer was apparently able to identify to an EU wholesaler that the serial numbers being verified were no longer in an active state as they had been determined to be dispensed or inactivated due to known duplication. As this article points out, this allowed at least some product to be quarantined prior to dispensing.
6. Know When/How to Perform Product Ownership Tracing- Many trading partners are currently relying on paper pedigrees or transaction statements on packing list or electronic lot level files, to understand who to ask in the event of a suspicious product investigation. The FDA DSCSA guidance, website as well as a site built for dispensers by several organizations can help you determine steps you should take. Keep in mind that state and federal agents may be able to assist if you are unable to determine the transaction history of a product.
7. Clearer Identification of Exempt Product- Any secondary trading partner from the manufacturer loses the ability to directly be informed when a product has been granted an exemption or waiver. Currently the FDA does not publish a list of products that have been granted exemption and some have expressed this should continue to be the case to avoid bad actors having a list of these products. This means that there is currently no easy way for any dispenser to know which products are exempt without stopping the processes to reach out to the manufacturer of record. We are hopeful that industry secure means will be developed to share such information with dispensers and state regulators more clearly.
8. Minimize Delays in Full Enforcement of DSCSA- DSCSA includes the need for a cascading of data that requires downstream distributors and dispensers to rely on upstream manufacturers, repackagers and direct distributors. While it is clear downstream stakeholders such as dispensers have had limited ability to test and implement, this can only be resolved by ensuring full adoption and compliance from upstream sectors. We support a similar cascading of stabalization or enforcement that would require compliance based on a sequence of enforcement for shipments from manufacturers, then from repackagers, then from distributors and finally receipt at dispensers.
As these cases highlighted, one of the best initial defenses is any concerned professional who handles the product whether pharmacist, material handler, procurement, quality agent or any other authorized stakeholder.
We are honored to help clients greatly increase these defenses through best practice informed systems, procedures, and training that we offer to fully vet through DSCSA assessment or mock audits. We encourage our peers and clients (past, present, future) to join the discussions by participating in industry events, conferences and other groups meeting regularly on DSCSA.
Ten Count continues to offer a free consultation to help trading partners of any size or sector understand their requirements, comply and have processes independantly pressure tested while minimizing wasted spend.
Reach out to us through info@tencountconsulting.com
