Comments on: e-Pedigree: Delay, Delay, Delay http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/ The Business of Pharmaceuticals Wed, 08 Feb 2012 14:53:10 -0500 hourly 1 By: freesoft32 http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/comment-page-1/#comment-109489 freesoft32 Sun, 20 Mar 2011 12:36:44 +0000 http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/#comment-109489 thanks you very much!!!! thanks you very much!!!!

]]> By: engelliler http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/comment-page-1/#comment-96642 engelliler Wed, 29 Dec 2010 09:49:21 +0000 http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/#comment-96642 I actually agree with your comment to the stage of development of different ideas can be created I actually agree with your comment to the stage of development of different ideas can be created

]]> By: Adam J. Fein http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/comment-page-1/#comment-574 Adam J. Fein Wed, 23 Apr 2008 01:35:44 +0000 http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/#comment-574 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 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

]]> By: Adam J. Fein http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/comment-page-1/#comment-491 Adam J. Fein Sat, 29 Mar 2008 17:04:06 +0000 http://blog.pharmexec.com/2008/03/28/e-pedigree-delay-delay-delay/#comment-491 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 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

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