Tuesday, February 10, 2009

Dear FDA: Eight is (Not) Enough

As you may know, the Food and Drug Administration Amendments Act of 2007 requires the FDA to establish technology standards for the pharmaceutical supply chain by 2010. The FDA requested comments and information earlier this year – see the links in The FDA and EC Dive into Supply Chain Security.

The U.S. Food and Drug Administration recently provided guidance on the use of Standardized Numerical Identifiers (SNIs) for prescription drug packages. The guidance document can be accessed here:
http://www.fda.gov/oc/guidance/drugsupplychain.html

One of my clients – an executive in the corporate supply chain organization at a big pharma company – pointed out a possible limitation about the FDA’s proposed eight-digit serial number. Perhaps inspired by your friendly neighborhood Drug Channels blogger, his comments were inspired by the inestimable Dick van Patten. His reference is admittedly much classier than my proposed title “Length Matters.
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Since he wants to remain anonymous, I’ll let you read his thoughts directly. Feel free to post any comments below.
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“The serialized National Drug Code (sNDC) is comprised of the 10-digit NDC code followed by an 8-digit serial number. One issue not mentioned previously is the length of this serial number.

  • An 8-digit number provides for 99,999,999 serial numbers, or to round-up, 100 million numbers. This is probably not an issue for most NDC codes but what about high volume SKUs? Wouldn't vaccines need greater capacity? High-volume generics?
  • Any single SKU that has sales of more than 10 million units per year will have less than 10 years' worth of numbers. Perhaps peak sales cannot be sustained for that period but why push it?
  • Any additional serialization features that manufacturers would like to pursue, such as step-increments to the numbers or other algorithms to make it more robust, will be virtually impossible with only 8-digits available to utilize.
Fortunately, the SNI can be incorporated into a serialized Global Trade Identification Number (sGTIN), which allows for serial numbers of up to 20 digits in length. This is the approach that our serialization program will take in order to maintain consistency with the GS1 Global Standards organization. While the FDA’s proposal for a new number construct is puzzling, at least progress is being made. It does not negatively impact those of us who are embracing GS1 standards.

Sorry Dick Van Patten – Eight is NOT Enough!”

4 comments:

  1. Leave it to the government to re-invent a Y2K scenario.

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  2. Which goes to show the thoughts that go into this. Why do you need the NDC in the serial number anyway? If it is a serial number you need to tie it back to other data to have any meaning so incorporate the NDC is the "other data" and make the serial number just a number! This is not that complicated but, again, the government and the industry has made it so.
    -A

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  3. Industry Collaboration Required,
    Over the last decade, many retail drug chains have centralized their pharmacy databases thus requiring unique identifiers to be assigned and maintained for patients, physicians, third-party ids, etc. The process of “cutting over” is very difficult because each pharmacy had a distributed system with its own unique set of identifiers. Therefore, each system was converted in sequence, scrubbed, purged, merged and eventually centralized. A centralized solution required that each prescription number be unique for tracking and tracing purposes. In concept, this is very similar to what is required to implement a Standardized Numerical Identifiers (SNIs) for prescription drug packages
    A relatively inexpensive case study that outlines the technology, design, expenses and issues encountered by the retail chains to convert to a unique id solution would be very beneficial. Additionally, the result are needed to establish cost and benefit analysis and provide an open architecture model needed to control expenses and reduce the development resources required.

    Carl H

    ReplyDelete
  4. Carl H. makes great points! There is a wealth of experience that can be garnered by the HHS through it's AHRQ on healthcare information technology. The reason that $20 billion of stimulus is being earmarked is the understanding of how difficult a mass roll-out of technology can be across our country.
    Then again, maybe deployment of GS1 standards on GDSN's utilizing EPCIS data structures and data carriers utilizing SGTIN's will answer HHS's vexing question......
    How do you get all members of the supplychain to communicate online/realtime.

    ReplyDelete

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