Sometimes it’s better to start with a blank slate. That may be true of establishing e-pedigree compliance, if the case of Med-Health Pharmaceutical Products is considered. Med-Health, based in North Las Vegas, Nevada, came into being in 2006 as a pharmaceutical (and medical device) supplier and repackager. Given Nevada’s strict electronic pedigree laws, Med-Health made e-pedigree a priority from the start.
“Our biggest challenge that we had was that we didn’t have any past history,” says Sam Haddad, the company’s senior vice president. “Unlike some other companies that might migrate or have some lengthy data that they can pull from one system to another system, we basically didn’t have the luxury of doing that and started from scratch.”
But that gave Med-Health to select IT solutions with pedigree in mind. It selected SAP for its enterprise architecture (more specifically, an off-the-shelf solution from Idhasoft that provides the core of SAP for small- and mid-size pharma companies), and contracted with SupplyScape for an e-pedigree solution. “Before we even opened our doors, we had to provide and show the Nevada Board of Pharmacy that we had a compliant e-pedigree program in place and that every sale that we make would have a pedigree document with it,” Haddad notes. “We chose the electronic route, and went through SAP and chose a third-party [SupplyScape] to do the electronic pedigree for us. The entire pedigree from receiving to shipping and out to the customer is all done behind the scenes in SAP.”
When Med-Health issues a purchase order from a drug manufacturer, for example, SAP triggers the start of the pedigree process and all of the relevant data (lot numbers, quantities, expirations, etc.) is transmitted to SupplyScape as product is transferred and barcoded information is scanned at various transit points. When the sales transaction is complete and the drugs are in the hands of, for instance, a pharmacist, SupplyScape verifies the chain of custody and a pedigree certificate is automatically generated and presented to the end customer.
Most of the company’s supply chain partners are equipped to provide data that is automatically integrated into the system. A few wholesalers that Med-Health works with have incompatible pedigree solutions, in which case a PDF document must be created with the relevant pedigree information, and incorporated into Med-Health’s system as an attached file.
The pedigree solution implementation was fairly quick and straightforward, Haddad says, but not without challenges. For one thing, Haddad says, even though SupplyScape is an SAP partner, more customization to the system had to be done than initially thought, slowing implementation. Also, he says, the SupplyScape solution was inflexible in some respects. “If you accidentally logged in the wrong lot number and transmitted it, there is no way to correct the mistake unless you cancel every transaction before that,” he explains.
And, on occasion, the pedigree documents created misrepresent transactions—pulling data from the wrong field, for example—causing the pedigree to fail. As a result, there are still instances in which Med-Health has to complete pedigree documents manually. Med-Health is working with its vendors to correct these issues, Haddad says.
On the whole, however, the board of pharmacy has considered Med-Health’s e-pedigree a model system—unusual in a state where wholesalers are scarce due to the tough laws. “When we started, they investigated us a lot to make sure everything was legitimate,” Haddad says. “We brought them into the picture during the design and construction of our facilities, and when we brought SAP and SupplyScape on board. Our facility is always open to them.”