Tuesday, January 22, 2008

CA Pedigree: Going to '11?

In my opinion, a postponement of California’s e-pedigree requirements to 2011 is now inevitable since the Board of Pharmacy has recently received sufficient evidence to justify a delay.

The California Board of Pharmacy’s Enforcement Committee meets on Wednesday. While e-pedigree is not on the official agenda, the Board has recently received a wave of requests for delaying implementation until 2011. However, I suspect that the Board will postpone their decision until later in 2008 so as to keep the pressure on the industry.

NONE MORE CLEAR

Under California law, the Board has the ability to delay implementation of e-pedigree requirements until 2011 if the board determines that “manufacturers or wholesalers require additional time to implement electronic technology to track the distribution of drugs within the state.” According to the December 5 Report of the Work Group on E-pedigree, a decision to delay must be “based on facts, not statements, and the data must demonstrate that a delay would be in the public interest.”

As a result, an Implementation Submission Statement Template was developed to collect information about e-pedigree progress. And guess what? The Board received 42 responses regarding the industry’s readiness to implement e-pedigree by January 1, 2009.

I found 35 responses online in Letters Regarding Readiness to Implement E-Pedigree (Part 1) and Letters Regarding Readiness to Implement E-Pedigree (Part 2). Warning: These are BIG files -- 282 pages totaling 55 MB.

Here’s a brief rundown of the 35 responses in these files:

  • Manufacturers: 24 of 26 letters specifically requested a delay until at least 2011.

  • Wholesalers: 2 of 2 letters requested a delay until 2011.

  • Pharmacies: 4 of 5 letters requested a delay until at least 2011. The fifth submission was from Wal-Mart and simply listed their serialization requirements for suppliers as of November 9, 2007.
(Note that I combined companies and their trade associations. Thus, PhRMA is counted with manufacturers, HDMA is counted with wholesalers, etc.)

The remaining two letters were from suppliers:

  • Catalent, the contract packaging company spun off from Cardinal Health (CAH), argued for a phased approach in 2009 instead of a delay to 2011.

  • BA Systems, a provider of RFID technology, recommended a delay to 2010 rather than 2011.
The 35 submissions provide specific facts and data about implementation activities and the intentions of individual companies.

How much more clear could this be? The answer is none. None more clear.

SMELL THE GLOVE

In my opinion, the Board now has sufficient evidence to justify a delay. There are also many sound reasons why enforcing the arbitrary 2009 deadline would be harmful to patient safety. Taken together, the responses cited explain these reasons very thoroughly.

As a negotiating tactic, the Board may choose to keep everyone guessing until late 2008, although posturing for an unrealistic deadline doesn’t sound to me like a very sensible way to ensure patient safety. (I also like the risk-based approach that I discuss in California Dreamin'.)

So, is this the end of the “delay to 2011” discussion? Probably not, so it’s worthwhile to remember the words of supply chain security guru David St. Hubbins, who said:

“Well, I don't really think that the end can be assessed as of itself as being the end because what does the end feel like? It's like saying when you try to extrapolate the end of the universe, you say, if the universe is indeed infinite, then how - what does that mean? How far is all the way, and then if it stops, what's stopping it, and what's behind what's stopping it? So, what's the end, you know, is my question to you.”

I agree completely.

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P.S. If you are like my wife and don't recognize the blokes in the photo above, read this.

6 comments:

  1. LOL! Tap Rules!!!

    Seriously, thanks for the update.

    ReplyDelete
  2. The deadline appears ready to 'spontaneously combust', just like the last Spinal Tap drummer (whom you so keenly left out of your picture) (!).

    ReplyDelete
  3. A lot of fun emails this morning -- there are a lot of other Spinal Tap fans out there in the pharma supply chain.

    They obviously realize that a 2011 deadline will be one louder.

    ;-)

    Adam

    ReplyDelete
  4. Seriously, the comparison of this situation to a Spinal Tap incident is entirely appropriate. It is as if Nigel and Derrick are running the Board of Pharmacy. Trying to implement an e-pedigree/serialization solution without any regulations or official standards is the equivalent of designing a Stonehenge monument stage set on a napkin. You know it ain't gonna work the way it is intended.

    ReplyDelete
  5. Pharmaceutical Commerce magazine posted some additional information: Buckle your seatbelts: It’s California Pedigree Week!

    Adam

    ReplyDelete
  6. Let's hope that the CA BOP realizes it's newest requirements can be summed up in one short review: S#@t Sandwich.

    Anyone who can break up my Regulatory duties any amount of Tap is my hero.

    Thank you.

    ReplyDelete

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