PharmExec Blog

e-Pedigree: Delay, Delay, Delay

Photo from WikipediaLooks like pharma companies and wholesalers will have two more years to get the kinks worked out of their electronic pedigree system.

The California State Board of Pharmacy just announced that it would delay its e-pedigree law that would require all drugs that pass through the state to be electronically tracked. The date has been pushed from January 2009 to January 2011 giving everyone–from pharma to the pharmacists–a chance to properly implement their systems.

The plan is to have every drug coded with some form of tracking device–be it RFID tags, traditional barcodes, or 2D barcodes–to follow a shipment as it travels down the supply chain. Companies such as Pfizer are tracking every bottle of Viagra with RFID chips that can sense the contents of a pill bottle without even opening a shipping container.

California law isn’t requiring anything that fancy, but it insists that there is some form of chain of custody that can document a drug from manufacturer to the point of dispensing.

The pedigree also can be used to track expired goods, find a missing shipment, or determine whether an unmarked shipment has been diverted into the supply chain or if it contains counterfeit product.

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4 Comments

  1. Posted March 29, 2008 at 12:04 pm | Permalink

    I’m puzzled by the statement that “California law isn’t requiring anything that fancy.” I think you are minimizing the real-world challenges of this law.

    Existing technology can be used to comply with California’s law, but current product identification and supply chain practices are not sufficient for CA e-pedigree. For example, many products have bar coded UPCs to identify a specific product. Every package of a particular product/size combination can have the same bar code.

    In contrast, serialization (under CA law) requires a *unique* identifier on each individual package. The volume of data is much, much, much greater b/c each specific package gets it own bar code.

    Thus, complete serialization with e-pedigree requires affixing a unique number during the packaging process, capturing and managing the data, adding pedigree information as the product moves down the supply chain, and then making these data easily (but securely) accessible. It also requires substantial lead time since serialization must happen during the drug manufacturing process, which can be months (or longer) from the time that the product is dispensed to a patient. Standards must also be developed and adopted by literally thousands of independent participants in the supply chain — manufacturers, wholesalers, pharmacies, and technology providers. The whole system must also be flexible enough to deal with all of the supply chain variations from manufacturer to patient.

    As I have noted in my blog, this is (becoming) feasible but neither easy nor cheap. And to put the pharma industry’s challenge in perspective, there were more than 4 billion prescriptions filled in the US 2007.

    Hopefully, the CA Board of Pharmacy can put aside their pharma-bashing and get on with the hard work needed over the next 33 months.

    Adam J. Fein
    http://www.DrugChannels.net

  2. Posted April 22, 2008 at 8:35 pm | Permalink

    FYI, the CA law may be moot since the introduction of a House bill H.R. 5839 Safeguarding America’s Pharmaceuticals Act of 2008, which will establish uniform national standards and preempt the state laws. I posted an analysis of the bill on my blog:

    http://www.drugchannels.net/2008/04/national-standards-its-about-time.html

    Adam

  3. Posted December 29, 2010 at 4:49 am | Permalink

    I actually agree with your comment to the stage of development of different ideas can be created

  4. Posted March 20, 2011 at 7:36 am | Permalink

    thanks you very much!!!!

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