By Rob Dewig, Vice President, Healthcare Solutions:
How big of an issue is counterfeit medication? Last year, law enforcement seized more than 115 million pills containing illicit fentanyl, almost half of which were made to look like prescription opioids. The Drug Supply Chain Security Act (DSCSA) aims to solve the counterfeit pill issue, but this alarming statistic highlights the urgent need for hospitals and pharmacies to implement serialized data tracking ahead of FDA’s full enforcement deadline — and curbing counterfeit products isn’t the only practical reason to do it.
Healthcare partners may hesitate to start scanning serialized data now because the full benefits aren’t immediately apparent. Not all manufacturers and wholesalers have begun sending the necessary EPCIS data downstream, meaning some scans won’t yield complete information. Manufacturers, dragging their feet on compliance, are causing bottlenecks, while wholesalers are stuck in the middle, testing quarantining procedures and anticipating delays in product flow. Data flaws exist at every level. This uncertainty can lead to frustration, but waiting isn’t the answer.
Early adoption benefits the entire supply chain. Healthcare facilities can ensure drugs are safe and secure, as well as legitimate. The enhanced visibility that comes along with serialization is an added benefit for manufacturers, allowing them to monitor downstream product flows more accurately, adjust production as needed, and minimize waste. For retail chains, serialized data means more efficient product transfers between pharmacies, reducing costs and improving access, especially during regional drug shortages.
Here’s what your facility should be doing now: focus on getting personnel trained on scanning serialized data and confirm your facility’s Global Location Number (GLN). If you trade products externally, you’ll also need a Global Company Prefix (GCP). With this information in hand, you can start working with serialized data now, ensuring that your processes are in place well before full enforcement.
While the DSCSA deadline has shifted— starting now isn’t just proactive; it’s essential.