I just posted the official announcement from the California Board of Pharmacy on my blog:

http://www.drugchannels.net/2008/03/ca-e-pedigree-going-to-11.html

Spinal Tap fans will appreciate the graphic!

Adam

Thanks for your post and clarifications. But I am not being totally honest. Not only am I a patient I am also a patient who has some fairly good experience in the “injectable drug” market. As you know, there is an enormous amount of information that has to be controlled and tracked in this area. No doubt that this causes great headaches for the high volume of prescription drugs that are already processed.

One of the big drug distributors sells their service on the basis that they already have this technology and knowledge. In fact they say they are the experts.

Yet, I believe you are saying they can’t possibly be the experts now, because the technology is not quite up to date.

I am sure you can understand my frustration, I uniquely have a seat on both sides of the table.

Once again thank you for your clarifications, do not take my frustration personal, but hopefully you will think about it more.

Current bar codes are not sufficient for CA e-pedigree. 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.

Serialization (under CA law) requires a *unique* identifier on each individual package. Bar code technology can be used for this task, but 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 manufacturing process, which can be months (or longer) from the time that the product is dispensed. 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 note in my blog today, this is (becoming) feasible but neither easy nor cheap. And to put the industry challenge in perspective, there were more than 4 billion prescriptions filled in the US 2007.

Adam

If you read my blog (Http://www.DrugChannels.net), you will see that I strongly oppose all efforts that weaken the safety of the pharmacy supply chain. I work hard to provide a knowledgeable, fact-based, independent, and non-partisan perspective on the complex issues.

Please feel free to email me or post a comment on my blog if you’d like to be more specific with your criticism.

Adam

With all the consulting that you do why would implementing this law be so difficult? All products at the moment have bar codes on them and all are being scanned. You must also provide your services to the big drug distributors.

What can you share with us about the high mark ups they impose on drugs, the “channel stuffing” capabilities they provide their clients with (a game of peek a boo with the inventory).

Maybe they just haven’t figured out how to “hide” the artificial costs?

Here’s some cost for you: Big Pharma sells one month supply of cancer drug to BIG M Distributor for $2,400.00 Cancer patient goes to drug store and pays $3,800.00 for same drug.

The pharmacy didn’t get most of the mark up. In fact, when the pharmacy was questioned they feared for their business and said that was the price they were forced to charge. It seems BIG M can arbitrarily change the prices whenever they want which would put the smaller pharmacies out of business and force patients to buy from the Pharmacies owned by BIG M.

Quite a racket they have going there….

Just think there are people dying because they can’t afford treatment or they have to give up food to buy the pills..

Patients are told, “the cost of the drug is so high because of the innovation, risk, clinical trials and we provide free drugs to marginal income patients”

BIG M distributor do nothing to innovate, research and bring these drugs to market. They should get their hands out of my pocket….

Hope you do not consult on any of these things, and I certainly hope you don’t get cancer….

I’ve been following this story closely. The reality is much more complicated than Mr. Goldenberg implies. For some objective analysis of theBoard’s actions, see:

http://www.drugchannels.net/2008/03/ca-e-pedigree-underground-regulation.html

http://www.drugchannels.net/2008/01/pedigree-and-obscenity.html

Regards,
Adam