The drug manufacturer has developed a global solution for track and trace to promote patient safety and to meet legislative mandates.

EMD Serono Inc.’s (Rockland, MA) development of secure supply-chain systems began in 2002 with pharmacist authentication of serialized packages of its human growth hormone drug Serostim.

Upon the company’s acquisition by Merck KGaA in 2007, EMD Serono embarked on a global track and trace solution for identifying product throughout its supply chain, starting with its manufacturing facilities in Italy and Switzerland.

“We knew early on that we needed a global solution for track and trace, for meeting legislative mandates and as a means of promoting patient safety,” says Richard Feldman, vice president, trade and product security, EMD Serono.

“Our products are high-value injectables and as such, are vulnerable to wrong-doers. We said at the start that we wanted to capture all of the events in our supply chain from the time it leaves the factory through to pharmacy distribution,” Feldman says.

“The core of everything we do revolves around patient safety,” he adds. “We are always asking, how do we enhance the patient’s journey, improve the patient’s experience, and promote patient safety.”

Two-dimensional Data Matrix bar codes containing SGTINs are pre-printed on the saleable-level boxes. Data captured when bar codes are scanned at the end of the packaging line are shared with the company’s U.S.-based third-party logistics vendor. When orders are picked and shipped, the information is transferred to a third-party e-pedigree vendor. After receiving product, wholesalers and pharmacies can retrieve the pedigree documenting each change of ownership via a Web portal.

The track and trace solution complements the Serostim Secured Distribution Program (SSDP) that EMD Serono developed in partnership with FDA to curb incidences of diversion and counterfeiting of Serostim. The drug is used to treat HIV patients with wasting or cachexia.

In the SSDP, network pharmacies today are contracted as authorized locations for filling and dispensing Serostim prescriptions. After the pharmacy buys the product from the wholesaler, EMD Serono drop ships the order directly to the pharmacy and bills the wholesaler.

EMD Serono sends the shipment’s serial numbers to the switching company that handles the pharmacy’s transactions with prescription payers. If the serial number on a box for which the pharmacist is asking for payment doesn’t match the item shipped to that pharmacy, the switch rejects the claim.

“A rejected claim now becomes a matter of record [for which] there may or may not be a good explanation. When we identify suspicious activity, we work closely with FDA’s Office of Criminal Investigations. Since the SSDP began, we have had success in preventing incidences of diversion and counterfeiting of Serostim,” Feldman says.

Having implemented solutions for pharmacist authentication and supply chain visibility, the company is now expanding 2-D coding to all products, as well as upgrading technology.

For managing the serialized information, EMD Serono developed an EPCIS-like event-tracking system. In April, it is migrating its ERP platform from an Oracle to SAP solution.

“When we first embarked on this we tried to capture as much variable data as we possibly could, but also remain flexible to modify our internal system to emerging standards. We are developing a second-generation secure distribution model [as] the current program doesn’t have the scalability we need. And we are prepared to move to an EPCIS environment,” Feldman says.

The company is exploring the impact of RFID on its biopharma products. “Recent short-term stability testing at the University of Florida showed very slight product degradation within normal limits. We have to determine what further testing needs to be done. There are no immediate plans to use RF at the packaging level, but we see it as a promising technology,” Feldman says.