May 10, 2006Starting July 1, Florida's pedigree law will require pharmaceutical distributors to document the chain of custody of prescription drugs in the state. On Jan. 1, 2007, a California statute with similar requirements will come into effect, and other states are considering comparable pedigree laws. Complying with those regulations will require disciplined processes that can track and document the drugs as they move through the supply chain.
To that end, Scottsdale, Ariz.-based Cyclone Commerce and systems integrator Axway recently introduced a software package, the Healthcare Compliance Suite, which combines several applications designed to help drugmakers and wholesale distributors, logistics providers and retailers serving the health-care market to better manage and monitor their manufacturing and distribution operations.
Available as either stand-alone or hosted software, the suite is built on a Web-based infrastructure and includes data-translation and data-cleansing technology Cyclone Commerce received in December 2005 when it merged with Axway, formerly a wholly owned subsidiary of the Paris-based Sopra Group. Data-cleansing tools transform data from a source system format, such as a proprietary code, into a predefined, standardized format, such as XML or HTML, as specified in HCS and other packaged software.
Translation and staging tools operate in a similar manner; many refer to these as ETL tools, or "extraction, translation, and loading" software. With the new data-translation and cleansing-technology stack, the suite can readily accept data culled from RFID systems, says Daryl Eicher, Cyclone Commerce's vice president of health-care and industry solutions.
"Without the investments we've made in standards and data cleansing and staging, we wouldn't have been able to say we can pull that data in," Eicher says, "but now it is possible."
The Healthcare Compliance Suite includes eSubmissions, which lets companies electronically submit documents—such as the applications drugmakers submit to get a new drug approved for use—to the appropriate agencies. Such agencies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and Japan's Ministry of Health, Labor and Welfare.
The suite also includes the Cyclone Controlled Substance Ordering System for the electronic submission of controlled-substance documentation to the U.S. Drug Enforcement Administration (DEA), and the Cyclone Trade Activity Manager, designed to help pharmaceutical manufacturers and distributors manage their contractual agreements.
"A pedigree is a legal document that needs to be generated, archived and validated every step along the chain to ensure not so much that it is the authentic product, but that the product you are receiving comes from legitimate channels," Eicher explains. The ePedigree software converts order and shipment information into a pedigree that is legally binding and can be combined with other information, such as product lot numbers, to create a clearer view of what's referred to as a chain of conduct, detailing who handled the product.
Combining pedigrees with unique product serial numbers and other RFID data will provide even greater track and trace functionality, according to Eicher. "A pedigree says the product you get has been handled only by legitimate sources. That's important. But if I really want to stop counterfeiting, I need to know that it came from valid handlers, and I also want to validate the product itself by checking that the serialized number scanned from the product can be correlated with a serialized number stored in a database," explains Eicher. "I can then find out if, for example, Pfizer actually made that specific product. By checking that, Pfizer or any manufacturer would have the opportunity to say, 'Wait a minute; we already registered a sale on that product. Why are we selling it again?'"
Cyclone Commerce is working now to expand the Healthcare Compliance Suite's functionality so that it can not only accept RFID data but also act on that data. For example, the RFID data could trigger an advanced shipping notice or bill of lading in an order management system tied to the HCS Trade Activity Manager. "There are some very interesting track and trace applications we can add, such as very detailed inventory and reverse logistics," Eicher says.
