Medical Device Link.

Originally Published PMPN December 2003

NEWS

Tamper-evident packaging isn’t just a stand-alone solution, Bayer Biological Products (Bayer BP; Research Triangle Park, NC) has found. Rather, the company has used it as a springboard for an entire patient safety program. The program has brought changes to its manufacturing, supply chain, distribution, and patient outreach programs.

In March 2002, the company discovered that several vials of one of its products, Gamimune N, had been tampered with. The vials had been diluted with tap water and resold into the supply chain. As the product was a biological used almost exclusively in hospitals, it was not required to have tamper-evident packaging. As a result of that incident, however, all Bayer BP products have tamper-evident packaging. The company has also launched a comprehensive antitampering initiative that extends far beyond packaging. 

“We’ve taken a very holistic approach that doesn’t just address the product itself but the whole process,” says Gunnar Reimann, Bayer BP’s president. “That means the whole supply chain, including the distributors. We’ve reduced the number of distributors we are working with, and we do audits with them and have language in their contracts that allows us to do so.”

The company’s first response was to add a sealed tab on the outside of each box containing vials of Gamimune N. Eventually, all of its plasma products manufactured at its Clayton, NC, facility will have shrink-banding with embossed packaging. Internally, Bayer BP tightened up its manufacturing and quality assurance programs to ensure that product was being packaged to specification. But the initiative extends far beyond its own plants.

“Part of the program is that we taught personnel in the hospitals how to sense if one of our products had been tampered with and what to do if they find one that has been,” says Reimann. “Also, a lot of patients self-infuse, and we wanted to make sure they had the appropriate information.” The company made some of these efforts in conjunction with the Immune Deficiency Foundation. 

Most notable, perhaps, has been the creation of the Bayer Direct program. This represents a major change in drug distribution philosophy. It enables patients to obtain their drugs directly from Bayer, which is almost unheard of in the U.S. prescription drug industry. It also allows patients to track by computer the shipment of their drug. The program is optional, but it has attracted much interest, Reimann says. “This is very rare,” says Reimann. “This option offers direct contact with us. We believe we will see more of this kind of thing in the future, as people become aware that tampering can also happen to prescribed products.”

Other firms could justify adopting these initiatives based on Bayer BP’s success with them, Reimann says. While the program has “cost money and taken resources away, it has been worth it, as it’s been recognized by our customers.”

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