Learn As You Go

 

 

Serializing all drugs for electronic pedigrees will be slow in coming. After all, when the early adopters need more time beyond January 2009, won’t everyone else? Slow, though, is better than nothing.

At the two most recent meetings of the California State Board of Pharmacy’s Electronic Pedigree Enforcement Committee, both Pfizer and Purdue Pharma suggested that more time is needed to comply with the state’s pending rules.

PMP News managing editor Anastasia Thrift reports that at the board’s January 23 meeting, Purdue’s Mike Celentano asked the committee for a “2011 date to continue getting up to speed.” The board applauded Purdue’s efforts with using RFID for OxyContin, which began in 2004 in response to Wal-Mart. The company started with bottle tagging using Gen1 UHF RFID, then progressed to Gen2 testing in June 2006 with case-level tagging and shipping in June 2007. Celentano said that 1.3 million bottles have been tagged to date. Purdue’s current program involves item- and case-level Gen2 UHF RFID, with item labels precoded by label converter.

However, Purdue was unable to offer a timeline for all its SKUs. It’s a “learn-as-we-go approach,” Celentano told the board. “There are a lot of dependencies on this. The reality of what you’re asking to get into the pipeline is a tall order.” Such requests for more time should not be viewed as failures to meet deadlines. Pfizer and Purdue are making progress, and their investments and efforts to date have provided the industry with valuable perspective.

Other companies are progressing, too. Biogen Idec will be using a system from Secure Symbology (Somerset, NJ) for serializing 2-D bar codes at Catalent’s Philadelphia facility. Codes will be applied to the packaging of the biotech firm’s products, which treat patients with multiple sclerosis, non-Hodgkin’s lymphoma, and rheumatoid arthritis.

Robert A. Hamm, Biogen Idec’s executive vice president, pharmaceutical operations and technology, reports that “in addition to meeting California requirements, 2-D bar code technology will prepare us for other states and countries enacting similar laws.” But to progress, you must invest. I am told that more than a couple of pharma or biotech companies are still waiting. Some are hoping for standards to emerge or for a technology or format to dominate before making any investments. They could wait for years.

Instead, these companies should take a “stepped approach,” advises Rob Ryckman, vice president of sales and marketing for CCL Label (Hightstown, NJ). The bar-code-versus-RFID debate should not hold up efforts; instead, focus on serialization, he told PMP News at the WestPack show in Anaheim, CA. “The data are what matter, not the technology.” One starting point is to begin adding variable data—the serial codes—to your labels. “Have your label converter add a 2-D bar code to your labels now and fill your warehouse with serialized items,” Ryckman said. “Then get a decent systems integration partner and work on collecting that data, archiving them, and mirroring them so you don’t lose the data.” Some companies may change their existing bar codes, while others may add second ones.

“Adding serial numbers to every product by the end of 2008 is next to impossible,” said Ryckman. However, “you have to start somewhere,” he said. “Counterfeiting is documented, so there is good reason for pedigrees. Companies need to grasp and use serialization technologies for the betterment of the industry.” So, learn from Pfizer, Purdue, and Biogen Idec, and go!

Daphne Allen
Editor

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