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On July 26, Oracle rolled out Oracle Pedigree and Serialization Manager, an application that allows pharmaceutical manufacturers to track drugs through the supply chain, limit counterfeit medication and conform with California state regulations on the sale of medication.
Pedigrees are electronic records that track the sale of a potentially harmful drug by a manufacturer and follow it through to the wholesaler, manufacturer and pharmacy.
A California drug pedigree passed in March 2008 will require electronic documentation by 2015 of all drugs sold, manufactured or distributed in the state.
“I don’t think that manufacturers are going to be let off the hook,” Gregg Malkary, founder and managing director of Spyglass Consulting Group, told eWEEK. “It does require them to make a lot of investments, but certain regulatory agencies are requiring organizations to provide better support of pedigrees.”
Protecting a company’s bottom line is also an essential consideration along with regulatory compliance for pedigree apps, according to Jon Chorley, vice president of SCM Product Strategy for Oracle.
“Ensuring supply chain integrity is not only about compliance and protecting your brand, it’s also about protecting your bottom line,” Chorley said in a statement. “By definitively identifying your products in the supply chain and providing a broad set of analytic insights on that data, Oracle Pedigree and Serialization Manager will deliver both. The result is a safe and secure pharmaceutical supply chain, combined with a strong ROI.”
Malkary agreed with the assessment of strong ROI potential for drug pedigree applications.
“It not only improves ROI but also improves patient safety because it improves the integrity of what the drugs are supposed to be,” Malkary said. “Patient safety is a huge issue.”
According to Malkary, Viagra and OxyContin are the two most counterfeited drugs on the market.
Oracle’s drug pedigree application will also help protect the legitimacy of returned products.
In addition, the software conforms to global regulations for managing the serialization of pharmaceuticals. It also supports the GS1 SGTIN (Serialized Global Trade Identification) format.
“Certainly as it moves through the supply chain, there’s a greater need to have increased or improved documentation as medications change ownership from one distributor to another,” Malkary said. “Some pharmacies are repackaging medications from scratch so they have a uniform way of prescribing them in the hospital.”
Oracle ePedigree application is built on the company’s Fusion SOA (service-oriented architecture) platform, the foundation for Oracle’s enterprise service applications. The pedigree application uses RFID technology to track pharmaceutical products.
The company’s announcement comes as counterfeit drugs continue to be a global problem. In November 2009, the Council of Europe drafted a treaty calling for more cooperation in the fight against counterfeit drugs.
IBM is also in the drug-pedigree market with its InfoSphere Traceability Server and WebSphere RFID products.
In a blog post, IDC analyst Eric Newmark predicted last fall when Oracle announced it would launch this application that the enterprise IT giant would become a leading drug pedigree provider by 2011.