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Pharma Supply Chain Hinges on Getting Good Data

By October 21, 2021DSCSA, News

LSPediA recently hosted the Behind the Scenes of EPCIS Data Exchange webinar for the pharmaceutical industry. With almost 100 unique entities in attendance, the session was a rousing success! 

We had the opportunity to hear from several LSPediA customers who are at the forefront of DSCSA implementation as key supply chain stakeholders. The webinar focused on the number one most important topic in the pharmaceutical industry: the need to exchange serialized data for each and every transaction up and down the supply chain. Come 2023, the FDA’s Enhanced Security Requirement will prohibit distribution without serialized production information data exchange. 

A live poll from webinar attendees indicates that the biggest challenge of data exchange is getting good data from the sender. Out of 89 responses, 60% were most concerned about current obstacles to receiving good data. Other prominent issues are logistical; 37.5% have too much volume by way of having too many trading partners. Another 35.4% are simply short-staffed. For these entities, manual management isn’t feasible. 

To meet this FDA requirement, the entire industry must take concerted action. If just one link in the supply chain fails, errors will propagate throughout the industry. Failure is costly; just take a look at all the issues currently facing so many supply chains in the country right now. Backlogged products at crucial chokepoints can lead to drug shortages and patients unable to access their life-saving medicine.  

“At the end of the day, we are bringing a product into the market. If we don’t have our product where it should be, that PO is basically regurgitating, you can run into failure supply fees and they can be very, very, very substantial” said Jay Madden, Director National Accounts from ACI Healthcare USA, a virtual manufacturer relying on a dozen Pharmaceutical Contract Manufacturers (CMOs) from India, China, Bangladesh, and the US.  

A majority of pharma manufacturers utilize a Third Party Logistics (3PL) provider for their day-to-day warehousing and distribution. Gary Davis, Technical Operations Director from Cardinal Health 3PL, emphasized the importance of moving quickly on EPCIS data exchange implementation. “At a 3PL, we’ve got manufacturers at different points on the journey. For the manufacturers who are proactive in working with us on data exchange today, it’s amazing how many issues we’ve already worked through. These are issues you want to address today, not in 2023. So that’s why we’re encouraging all manufacturers to start EPCIS data exchange as quickly as possible.” 

And make no mistake, starting the testing process early is essential. LSPediA data, based on total 7,720 EPCIS transactions, shows that EPCIS data failure in the Production environment is 36%. In the Test Environment, the error rate is a staggering 92%. 

For Ameer Ali, Sr. Director Manufacturer Operations at AmerisourceBergen Corporation, early testing is the number one priority. “We have almost 450 suppliers. 59 suppliers are currently live and sending us EPCIS data in production today. A large focus right now is testing the data and the physical products, manage exceptions, because that’s our future state,” he said. 

And as for why so many companies are prioritizing testing? Ameer continued, saying “Exception handling is a complex thing. There are many different scenarios that require different reactions, solutions, sometimes different personnel to deal with. We need that process to run like a well-oiled machine, so that we can keep the product moving.”  

As the poll results indicate, the pharmaceutical supply chain hinges on getting good data. Before we can get good data, however, we need to be able to detect and manage data errors. To learn more about exception handling, join the upcoming part 2 of the EPCIS webinar series on 10/26, Managing EPCIS Alerts and Exceptions.