In a long awaited and much anticipated move the Healthcare Distribution Management Association (HDMA) published updated guidance for the formatting, encoding and placement of barcodes in the U.S. pharmaceutical supply chain. The document is called “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain 2011”. The guidance is aimed mostly at pharma manufacturers and repackagers who place barcodes on their drug packages, cases and pallets. The last time the guide was published was in 2005 and this new edition includes some significant changes that everyone in the supply chain who deals with product and shipping container labeling should be aware of.
The updated document can be downloaded from the HDMA Marketplace web page. It is free to HDMA members. Non-members will need to pay a fee but don’t let that stop you from downloading a copy if you have any responsibility for applying or reading barcodes in this supply chain because you will need to make changes to keep up with the direction of the technology and the industry.
Full disclosure: I work for a company that is a member of HDMA and I contributed to the development of this updated guideline, but this essay is not a marketing pitch for the benefit of HDMA or my pride. Rather it is to help generate alignment around a common approach within the supply chain.
HDMA GUIDELINES FOR BAR CODING IN THE PHARMACEUTICAL SUPPLY CHAIN
The guidelines provide the reader with the industry-specific information necessary to know how to apply GS1 and HIBCC standards in the U.S. pharmaceutical supply chain. It provides an excellent discussion of barcode standards, including some history which I made use of in my recent RxTrace essay “Anatomy Of The National Drug Code”. It explains how those standards should be applied to identify drugs at all levels of packaging as they move through the supply chain so that companies can maximize the benefits of barcode technology. This edition provides expanded guidance on the implementation of 2D barcodes and RFID on packages and shipping containers.
For the first time the HDMA now “…recommends investing in imaging scanners capable of reading Data Matrix and linear codes whenever auto-id procurement needs are under consideration.” This HDMA recommendation aligns well with GS1 Healthcare’s position as published in 2009.
Both of those recommendations make sense because we are now standing on the threshold between two barcode eras in the U.S. pharma supply chain: linear in our rear-view and 2D in our forward-view. Any investment in linear-only barcode reading and writing equipment now probably won’t reach the end of its full depreciation still in use.
Imaging equipment manufacturers have made great strides in the last decade in nearly matching the read performance of linear barcode readers and the prices have come down. Linear readers will probably always be cheaper than imagers but you should consider this lower cost a reflection of the fact that they are now in the “discount bin” of obsolete technologies.
Linear codes are not dead yet, but I think we are going to see a fairly rapid transition to 2D barcodes in this industry with the approach of serialization regulatory mandates here and abroad. See my RxTrace essay “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach“ for more on this.
The development of the HDMA guideline documents over the years have benefited by the contribution of George Wright IV, Vice-president of PIPS / Product Identification & Processing Systems, Inc. George is an automatic identification and data capture (AIDC) industry veteran and I have found him to be a bottom-less well of technical and historical knowledge in this area. Many sections in the HDMA guidelines have a depth and quality that come directly from George’s contribution.
If you think you already know how to properly format and print barcodes on drugs marketed and shipped in the U.S., you need this edition of the guidelines. There are some significant differences from the way things have been done up to now. The first section of the updated document is a Summary of Revisions. Here is a partial list:
- Addition of a unique serial number in the GS1-128 product identification bar code to product case labels;
- Addition of an optional but recommended 2D GS1 DataMatrix bar code symbol to drug packages and product case labels;
- Removal of ITF-14 as a Primary Data Carrier (bar code) option for product case labels;
- Removal of AI(22) as a Secondary Data structure option on product case labels. This is a major departure from the way things are done today because AI(22) currently appears on about 75% of all product cases in the U.S. pharma supply chain. The document provides details on what AIs to use in place of AI(22) and how to arrange them;
- Reduction in the minimum X-dimension for GS1-128 symbols. This move enables a slightly tighter linear barcode on case labels so that serial numbers can be added to them without blowing out the available space;
- Reduction in the minimum height for GS1-128 symbols on case labels. Another move to free up precious real estate on case labels so that serial numbers will fit in the barcodes;
- A new HDMA recommendation for adding GS1 serial numbers to units and shipping containers;
- New information on standardized numerical identifiers (SNIs).
The HDMA does not enforce compliance with their guidelines. That is, if you don’t follow their guidelines no one from the HDMA will knock on your door or send you a cease and desist letter. The same goes for GS1. The U.S. FDA tightly regulates everything that appears on drug primary packaging—including the linear barcode that encodes the NDC—but they don’t regulate the contents of case-level product identification or shipping labels. While the U.S. Drug Enforcement Administration (DEA) does place certain restrictions on the information that appears on shipping labels (and they will come knocking on your door if you fail to follow them) those are limited to controlled substances.
So who enforces compliance with the HDMA guidelines? In reality no one does and that has led to a major missed opportunity for improved efficiency, accuracy and even profitability in the supply chain. Unfortunately very few companies follow all of the HDMA guidelines closely and that causes downstream trading partners to miss out on the opportunity to maximize the use of product case barcodes in operations like receiving, inventory management, picking and shipping. Barcodes are certainly used extensively in all of those processes today but case-level product identification labels cannot always be trusted because there is so much variance in compliance to both GS1 standards and HDMA guidelines. If you can’t trust the data in the barcode you can’t achieve its promise to maximize efficiency and data capture accuracy.
Some pharma manufacturers take their product case labels very seriously and have a program to ensure that they comply with the standards and with HDMA’s guidance, even without any heavy-handed enforcement. I applaud them. But the truth is, the majority of companies seem to take a quick stab at producing the barcodes on their case labels and then ship them out. If no one complains, they probably think they got lucky and got it right the first time. In other supply chains that face intense price competition these kind of inaccuracies and waste are not tolerated.
I keep thinking that something will trigger closer attention to detail in the construction of case labels in the pharma supply chain. Maybe this newly updated guideline from HDMA is just what we need. Do you think it will have a positive impact? Leave a comment below.