I’ve Changed My Mind, Follow GS1’s HRI Specification

That’s right, I now recommend that you follow GS1’s Human Readable Interpretation (HRI) specification for drug labeling, even when under a serialization regulation.  Previously I recommended against it (see “The DSCSA Product Identifier On Drug Packages”, and “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”).  Why have I changed my mind?  GS1 modified their

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4 thoughts on “I’ve Changed My Mind, Follow GS1’s HRI Specification”

  1. It is a no brainer for the patient and for patient interest – my only worry is real estate. It doesn’t look like a whole lot, but some of the products on lines I have worked on, the label is already tough to wedge the previous format into, that extra space will cause additional challenges and artwork changes.

  2. Dirk – thanks for your insightful post. My take is that AIs are for the benefit of scanners/software for parsing multiple data elements into the appropriate fields of the screen / application database. If code is not scannable, it’s not realistic to think a person would/could enter 30+ characters easily/accurately. Instead, they would/should enter each individual data element separately into its respective field which would not require entry of the AI. AIs printed as readable text, while well intended as an AIDC tool, will be a source of confusion for patients, providers, and others handling the product — at least for a while.
    Dave Colombo

  3. Thanks for reviewing the updated HRI specifications and evaluating them on their merits. The work group really tried to balance all of the factors that need to be considered for this issue. It is good to see that you see value in the changes. I hope others will have similar reviews, or will help us refine the design.

    1. Michael,
      Yes, the work group did a great job. I congratulate them on a job well done and I am glad to be able to spread the word about that work through RxTrace. As I pointed out in my essay, my only disappointment was that the GenSpecs still recommend the use of AI’s alone when a regulation does not specify text. Even in those cases, I suspect most drug companies will do the right thing and include both the AIs and human understandable text.

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