Authorizing Controlled-Substance Shipping on the Web

HDMA recognizes a Web-based technology provider, which could provide a model for electronic pedigree data.

In March, the Healthcare Distribution Management Association (HDMA) honored Legisym LLC for Express222, its Web-based digital technology service for replacing paper-based compliance with Drug Enforcement Administration (DEA) requirements. HDMA named Legisym a merit finalist in the 2011 Distribution Management Awards.

Express222 is approved under DEA’s Controlled Substance Ordering System (CSOS) for secure electronic transmission of Schedule I-V controlled substance orders without the paper-based DEA Form 222. According to the DEA, “CSOS certificates contain the same identification information as DEA Form 222, which allows for timely and accurate validation by the supplier.”

Drug manufacturers and suppliers can use CSOS to verify licenses before shipping controlled substances to drug repackagers, pharmacies, hospitals, or other practitioners. Express222 was approved as an alternative by the DEA in January 2009.
Using Public Key Infrastructure (PKI) digital signature technology, Express222 is a Web-based approach that does
not require hardware or software installation.

“We took the CSOS technology and changed the paradigm,” says David Kessler, Legisym’s chief business officer. “We removed technology infrastructure constraints and developed a software-as-a-service solution for the supply chain. Users do not need to worry about EDI requirements or changing in-house processes. Express222 is flexible and in most cases can be up and running within 24 hours.”

The service is designed to scale up or down to meet different supply needs. Drug compounder Unique Pharmaceuticals (UPI) has been using the system to provide just-in-time narcotics fulfillment to hospitals. More and more, hospitals are shrinking their inventories, so UPI had been juggling a lot of paper just to provide quality and service, explains UPI’s Cindy Chadwick.

“Our customers previously needed about a two-day lead time to overnight paper forms to us, and then we would overnight the order to the hospital,” she says. “Any time you have a lot of paper shuffling, there is room for error. We believe that Legisym has improved the security and handling of narcotics with web-based Express222. And the turnaround time has kept UPI at the forefront.”

Kessler says that his company is paying attention to the emergence of track and trace regulations to meet California’s 2015 law and beyond.

“Our system is not an e-pedigree system, but it could be a conduit,” he says. “There are connections between controlled substance transactions and the need for drug custody information. Data can be added to CSOS transactions, for instance.” Industry may want to look at handling e-pedigree data in a similar fashion.

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