CA e-pedigree: Delay to 2011 Now Likely

Implications: 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.

Analysis: As a reminder, the California State Board of Pharmacy plans to enforce significant changes to the state's drug distribution system as of January 1, 2009.  Among other requirements, the board’s statutes require development of an electronic “pedigree” that tracks each prescription drug at the saleable unit (item) level through the distribution system. A wholesaler or pharmacy may not sell, trade or transfer a dangerous drug at wholesale without providing a pedigree.  Pharmaceutical manufacturers must add a unique identification number at the point of manufacture to make the system work electronically.

OPTIONS FOR DELAY

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 a 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 many responses regarding the industry’s readiness to implement e-pedigree by January 1, 2009.

Here’s a brief rundown of the 35 responses posted online this week:

-- 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.

NEXT STEPS

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 --  serialize high risk products and rely on pedigree for the rest.