For those pharma and drug-distribution managers deep in the details of compliance with the US Drug Supply Chain Security Act, the problem of identifying which drugs have which barcodes has been a looming worry. DSCSA, passed in 2013, sets up the traceability system whereby drug packages can be traced to point of origin, the better to authenticate the package and to manage its distribution. Most manufacturers and their contract manufacturing organizations are hard at work meeting a November deadline for having all drug packages encoded with a serial number. Wholesalers, as represented by the Healthcare Distribution Alliance, are worried about what happens next for traceability.
To that end, HDA has been piloting a program to test how drug returns will be processed once the traceability data becomes available; in practice, returns (of which there are an estimated 59 million annually, many of which have traditionally required manual intervention to process) will be able to be automatically checked as they show up back at the wholesaler. Both for that purpose, as well as to make a critical first step toward managing traceability programs throughout the US pharma supply chain, HDA has started an initiative, Origin, to create a repository of Global Trade Identify Numbers (GTINs) for all manufacturers and wholesalers to participate. With the Origin GTIN repository, the first step in identifying a package—its NDC number and unit of packaging—can be recognized, verified and reported.
The NDC number, which is registered with FDA, identifies the manufacturer and, of course, the type of drug in the package. HDA stresses that Origin in not a comprehensive database of all drug serial numbers, but only the product identifiers, commonly referred to as GTIN-14. Specifically, the database will not contain the unique serial number of each package, nor the transaction history (which are elements that will eventually need to be retrievable for full DSCSA compliance). The GS1 organization, which set up the framework for GTINs, does not perform a repository function for pharmaceutical GTINs; HDA says that it has been coordinating its activities with GS1’s in this regard.
Earlier, HDA had chosen ValueCentric, a data-management firm, to build and maintain Origin; ValueCentric has been collecting and organizing EDI data between manufacturers, wholesalers and pharmacies for years. Bill Henderson, a consulting member with ValueCentric, says that Origin will have comprehensive security and identity-management features, and that while the database is not excessively large (in the gigabyte range), the need for manufacturers to keep their GTIN-14 data up to date is crucial. “A change in packaging, such as a case going from 12 to 24 units, means that the wholesaler handling that case needs to know accurately what is being received, and what is being shipped,” he notes.
HDA will be charging a subscription fee for manufacturers to upload their data, and for wholesalers to query the database. The whole system is voluntary—but its success depends on participation as broad as possible. To that end, HDA is running a webinar on April 28 explaining the program. A July startup is planned. More Origin information is available here.
“The traceability system mandated by the DSCSA will require a massive amount of frequent and accurate data exchange. GTINs must be up to date and correct to ensure the accuracy of master data,” said Perry Fri, EVP of Industry Relations, Education and Membership, HDA. “We are excited to introduce the industry to Origin — which will provide a much-needed, central, uniform method for manufacturers to share product master data with multiple, direct and indirect trading partners to ensure this consistency — and committed to help its users every step of the way.”