Electronic Data Interchange (EDI) has been around for more than 40 years. It’s employed across many industries, helping business partners easily share data and other information. One component of that system, EDI 856—more commonly known as the Advanced Shipping Notice (ASN)—became the standard data communication method for businesses needing to comply with the DSCSA’s product tracing requirement back in 2015. The big three wholesalers—Cardinal, McKesson, and AmerisourceBergen—achieved 100 percent ASN communications with their suppliers shortly after the DSCSA 2015 deadline. Using the ASN for standardization brought the wholesalers significant benefits, including improved compliance, operational efficiency, and an integrated order-to-cash cycle.
With so many upsides, you might think the ASN’s future is secure. But, as far as the pharmaceutical industry is concerned, there’s significant uncertainty about the ASN’s continued fitness for use in the supply chain.
ASN Limitations, and What Comes Next
Here’s the situation in a nutshell: Data sharing and communication is vital to the pharmaceutical supply chain, and will only become more so over time—but ASN won’t be in the driver’s seat forever. Why? Because the industry is moving rapidly to support EPCIS as its future communication standard. Let’s look at why.
When it comes to capabilities, EPCIS is far superior to ASN in terms of data communication. It’s like comparing an iPhone7 to a rotary phone. GS1 describes EPCIS as a standard that, “enables trading partners to share information about the physical movement and status of products as they travel throughout the supply chain – from business to business and ultimately to consumers”. In practice, this means that all partners in the pharmaceutical supply chain can inquire about and exchange serialized data if they are properly connected to the EPCIS platform.
Can’t ASN do the same? Not really. EDI uses point-to-point communication. It provides a technical platform that allows “talks” between two trading partners. For instance, let’s envision two trading partners that need to interpret data based on data mapping. The data mapping is specific to one trading partner. When you add the second trading partner, you add the second mapping, and so forth. An average manufacturer who ships to 30 wholesale trading partners has 30 outbound ASN maps. And every map is slightly different. For those of you who implemented ASN leading up to the 2015 DSCSA deadline, you know how maddening that is—you’re stuck with a standard that doesn’t standardize data across trading partners.
Which begs the question: Why doesn’t EDI standardize?
EDI standards lie in the rigorous format of the documents. It locks in the lines and spaces to allow trading partners to place the value of data elements according to the specification. EDI software then counts prefixes, lines, and spaces in the document, extracting value out of the data elements. The data elements themselves lack standards—which is a serious weakness in the system (as far as pharma is concerned, anyway). There are million real-world examples that highlight why this is a problem—a supplier item number is different from a customer item number, a trading partner address gets spelled five different ways, or a unit of measure can be “each” for some entries and “case” for others.
The Rise of EPCIS
The DSCSA mandates interoperable electronic product tracing by 2023:
SEC. 203. ENHANCED DRUG DISTRIBUTION SECURITY.
‘‘(g) ENHANCED DRUG DISTRIBUTION SECURITY.— ‘‘(1) IN GENERAL.—On the date that is 10 years after the date of enactment of the Drug Supply Chain Security Act, the following interoperable, electronic tracing of product at the package level requirements shall go into effect…”
EDI does not interoperate. It goes point to point. The FDA recognized long ago that point-to-point communication is simply prohibitive for pharmacies, clinics, practitioners, and consumers. EPICS is the standard that can get the job done.
“EPCIS would enable computers to communicate automatically with one another and pass data back and forth—with the right authentication—automatically,” said Mark Roberti of the RFID Journal.
Instead of receiving ASN data in different formats and trying to map them, a distributor can receive EPCIS data from all manufacturer suppliers in the same format, and then have it deposited in an EPCIS database. Plus, with integrated ERP and WMS, the EPCIS data can then be put to use for inventory management and logistics. Similarly, downstream trading partners—including pharmacies, clinics, and reverse logistics providers—can receive inbound EPCIS data and tag event data to reflect the true status of the physical product—dispensed, decommissioned, or disposed.
The Bottom Line on Effective Supply Chain Communications
EPCIS is a more efficient way for trading partners to communicate. The Healthcare Distribution Alliance (HDA), the major wholesale distributors, and many manufacturers support this GS1 standard. It is one of the final two test scenarios from the HDA pilot program that showed promise and feasibility. As a result, the big three wholesale distributors and many others are developing, testing, and connecting with their trading partners using EPCIS data front.
Giving the complexity of the pharmaceutical supply chain and the nature of DSCSA implementation, we know the road to EPICS adoption will be full of obstacles. By trial and error, determination, and—above all—a lot of work, I have total confidence that all of us in the industry will get there. After all, in 2015 we pulled through the ASN implementation. Our next challenge, EPCIS, will bring true interoperability to the industry. And that means a better and more secure pharmaceutical supply chain, with benefits for businesses and consumers.
How LSPediA Can Help Your Business
Complying with regulations and meeting DSCSA standards is complicated. And ensuring you have the right systems and processes in place as you work toward compliance is vital for your success.
We understand the pharmaceutical supply chain. And we can ensure you understand and successfully implement a DSCSA strategy using our industry-tested serialization toolkits and our new, innovative traceability solution, Rx Chain. Contact us today.
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of services and solutions that secure supply chains, protect against product counterfeiting, and help businesses comply with FDA regulations. Our customers are partners in the pharmaceutical supply chain, including manufacturers, wholesale distributors, dispensers, and reverse logistics providers. LSPediA helps customers define needs and implement best-of-breed supply chain and enterprise solutions that improve efficiency and comply with FDA and global standards.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals. Our expertise, experience, and technical know-how help customers derive maximum value from their investments, both now and well into the future.
For additional information, contact: Julianne Jahn [email protected]