DSCSA implementation will culminate with a deadline of November 27, 2023. The statutory components will enforce Interoperable Exchange and Verification at the package level by the unique product identifier.
As the pharmaceutical industry collectively and individually forms a plan on how to meet the mandate, the operational challenges and risks are recognized. The future state of operations not only need to manage a happy path of data exchange, but also an unhappy one where various exceptions exist.
As Benjamin Franklin once said. “If you fail to plan, you plan to fail.” When supply chain is the single important factor for your Rx products to reach the hands of the patients, doing nothing to prepare for 2023 is simply not an option. With the timeline looming closer, waiting to take action in a distant future also carries high compliance and business risks.
The number one risk faced by all trading partners is their ability to smoothly moving products down the supply chain meeting the data exchange requirement. Shipment disruptions become inevitable if trading partners are not adequately prepared for the 2023 requirement summarized in plain English as “no data, no shipment; bad data, bad shipment.”
What does that really mean? Starting in November 2023, serialized data (EPCIS) must be exchanged between trading partners to facilitate the shipment at the unit level. The FDA requires the sender to generate accurate data, the receiver to enforce the data quality at the point of receiving, and the sender to correct any data errors within three days. Anything short of this process will cause trade hiccups in the future state of operation.
“Exception handling is a complex thing. There are many different scenarios that require different reactions, solutions, sometimes different personnel to deal with,” said Sr. Director of Amerisource Bergen, Ameer Ali. “We need that process to run like a well-oiled machine, so that we can keep the product moving.”
The bigger issue about stuck shipment is limited physical warehouse space. Wholesale distributors’ receiving docks are designed for receive and put-away. When data errors disrupt the rhythm of receiving, the shipments is now stuck. Meanwhile, more shipments are coming in, so the stuck shipment needs to be cleared out. All of the Big Three have stated their limited options for quarantined shipments, including returns, or even destroying the stuck shipment under various optional conditions. That of course will result in significant lost revenues to both trading partners.
“We feel the pain when EPCIS files are late or error out. Shipments get set aside and pile up at receiving,” said Cardinal Health Manager of Pharmaceutical Information Technology Jeff Falardeau. “With our volume, it’s impossible for us to check and catch errors manually. This needs to be addressed with automation, and LSPedia, in my mind, provides the best product out there to help with exception management.”
The timeline for implementing the DSCSA provisions can be a real problem without the proper tools to tackle the issues. Moreover, staff shortages and overworked employees severely limit one’s capability to manage new workload. That’s where LSPedia and its innovative DSCSA Service Desk can provide a pathway to a compliant future.
Why spend time looking for errors, fixing data, and fielding calls from angry customers? Outsource it to LSPedia. The DSCSA Service Desk is a contract service that allows you outsource customer onboarding, EPCIS data exchange, and error fixing. The following services are included:
The Service Desk engineers will quickly resolve manufacturer’s trade data issues and assist the supply chain and trade organizations to improve customer experience and satisfaction.
“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.
Errors will happen, but they don’t have to derail your shipment. With the new DSCSA Service Desk, manufacturers can leverage LSPedia’s capability to find and correct data errors. It will take the workload off your hands and let your business focus on core objectives with the peace of mind that your shipments will be secure and on schedule.
To learn more about DSCSA Service Desk, click here to request information.