Novis Pharmaceuticals Provides E-pedigree with Serialized Bar Codes
By David Vaczek
Novis Pharmaceuticals (Miami) is labeling product with serialized bar codes to help customers track medication inventory and use. With the specialty therapeutics distributor’s RxID solution, customers scan the codes at established locations for monitoring product orders and internal distribution. Customers access serialized product information through a Novis Web site portal.
RxID is integrated with Nexus traceability software from SupplyScape (Woburn, MA; recently acquired by TraceLink Inc.) that Novis has adopted for electronic pedigree transactions with vendors and customers. RxID customers can click on a screen link to associate a serialized item with its pedigree.
“RxID is our patient safety initiative to help our customers track the products they purchase from us. We expect they will authenticate the information so they can then know a product is safe prior to its use,” says Jorge Rodriguez, vice president of operations.
Rodriguez says the system is rolling out this month, after pilot testing with several hospital customers.
The solution deploys the MedBoard Web-based medication tracking system from MedKeeper. Users log in to the portal for managing items through shipping, receiving, and within their facilities. Besides pedigree, screen information includes item identity, transaction history, inventory levels, location, and expiration status.
Novis assigns serial numbers to all items it receives. Labels with 2-D bar codes are printed for each item and inventoried. Labels are then applied only to products ordered by RxID customers. Customers scan bar codes at locations such as receiving departments, compounding stations, and refrigerators. Data are transported by wireless network or via tethered scanner to the Web-based software.
The software can be customized with business rules that key off the product information. “Many of our customers are interested in putting controls in place for setting minimum or maximum inventory levels, tracking the product, and ultimately ensuring the right product at the right quantity is administered to the patient,” says Rodriguez.
“If a product is scanned into station one, but not into station two within a certain time, an alert can be sent to a designated individual. The customer knows exactly what product came from us, whereas [without serialized marking] the same item with the same lot number may have come from different suppliers,” he adds.
In enabling the transfer of e-pedigree and business data, SupplyScape’s Nexus software-as-a-service (SaaS) platform interfaces with Novis’s SAP ERP system, integrating e-pedigree transactions with internal databases.
Rodriguez says 99% of downstream partners access the pedigree data by Web portal.
“Most of our customers don’t have the gateways to receive the pedigrees electronically. After the shipment leaves our building, we communicate that the pedigree is available through the Web site and provide an access code.
“Our responsibility is to make the pedigree available to the downstream customer prior to or simultaneously with its arrival at their dock,” he says.
A distributor with nationwide scope, Novis faces a mixed bag of approaches by trading partners to pedigree requirements. The firm provides electronic pedigrees on all shipments, regardless of states’ prevailing regulations.
“We developed our own set of criteria. We initiate an electronic pedigree on all shipments, primarily because it’s the right thing to do, but also because it lends consistency to the process. We classify each item received based on the compliance level of the pedigree. We then manage and control those items accordingly with the help of our business systems,” Rodriguez says.
While some states have imposed their own pedigree rules, all states have to comply with FDA’s PDMA regulation. The rule requires that items have pedigrees from distributors other than authorized distributors of record (ADRs), with the pedigree tracing back to the ADR.
As an ADR to some of its suppliers, Novis does not have to initiate a pedigree when shipping from a PDMA-regulated state to another PDMA state. Yet, the firm’s home state of Florida does not distinguish between ADRs and non-ADRs, requiring pedigrees from all wholesalers.
Hard-copy documentation, required by some states, has to be keyed into the system. Although manufacturers are not required to initiate pedigrees, in some cases the chain of supply has to be traced back to the manufacturer. “Getting information from the manufacturer is often the most difficult part of the process,” he says.
“The information we receive from our suppliers and the form in which it is being sent varies tremendously. Our standard differs from industry standards from state to state, so we have struggled to get consistent information from each of our vendors. Vendors only want to provide information that is required by the state they are shipping out of and by the state they are shipping to. We have to find a way to balance all of these inconsistencies,” he says.