In recent essays I have covered the “Anatomy of an NDC”, the “Anatomy of a GTIN” and the “Updated HDMA Bar Code Guidance: A Must Read“.  Now let’s put them all together.  Why would we need to do that?  Because the U.S. FDA requires many Over-The-Counter (OTC) and all prescription drugs marketed in the United States to have their National Drug Code (NDC) presented in the form of a linear barcode on the package.  Pure and simple.  To do that in a way that your trading partners can understand—that is, to do it interoperably—you need to follow a standard.  You have two realistic choices for standard approaches to this problem:  HIBCC or GS1.

The use of HIBCC standards is fairly common in the U.S. medical surgical devices supply chain but in the pharmaceutical supply chain it is very rare.  Most companies choose GS1’s barcode standards so that’s all I’m going to focus on in this essay.  If you want more information about how to do this with a HIBCC barcode find it here.

OVER-THE-COUNTER DRUGS:  GTIN-12

If your drug is sold over the counter (OTC), like aspirin and cold medications, the barcode on your packages will need to be scanned at point of sale (POS) terminals in the same way that any other consumer good is.  For that reason you need to put your National Drug Code (NDC) into a Universal Product Code (UPC) barcode in the United States.  A UPC-A barcode symbol contains a GS1 GTIN-12 data structure.  Here is what you need to do to convert your NDC into a GS1 GTIN-12:

1. Register your FDA Labeler Code with GS1 US who will convert it into a GS1 Company Prefix (GCP) and grant you the right to use it
   Recall from my previous essays that your FDA Labeler Code is either 4 or 5 digits long and a GCP can be anywhere from 6 to 10 digits depending on the fee you pay GS1 US when you register it.  In the case of FDA-regulated pharmaceuticals GS1 US will register a 4-digit FDA Labeler Code as a 6-digit GCP and a 5-digit FDA Labeler Code as a 7-digit GCP.  The reason is that they need to synchronize the length of the Item Reference portion of the resulting GTINs with the combined length of the Product Code and Package Size fields of your NDC.  This is to ensure that you are able to generate valid GTIN-based barcodes for every possible NDC that your Labeler Code enables you to generate.  You only need to register your FDA Labeler Code with GS1 US once as long as you keep up with the annual subscription fees so for subsequent drugs that use a Labeler Code that is already registered you can skip this step.  If you have multiple FDA Labeler Codes you need to register each one with GS1 US once.
   
   GS1 US has reserved GCPs that start with “03″ for owners of FDA Labeler Codes as shown in the following table.
   

   Click images to enlarge

2. From your new GS1 Company Prefix construct your U.P.C. Company Prefix
   Ah ha!  This is an esoteric step.  It is necessary because of the way GS1 merged the formerly North American-only Uniform Code Council’s (UCC) Universal Product Code (UPC) company prefixes with the European Article Numbering Association’s (EAN) European Article Number (EAN) company prefixes and made the whole combined scheme suitable for global company prefixes and yet retained backward compatibility with the UPC and EAN.  But you don’t have to follow any of that.  Here’s what you do.
   
   You take the GCP that GS1 US assigned you and you strip off the leftmost digit.  That digit is always going to end up being a zero because we are dealing with an FDA regulated pharmaceutical and GS1 US will make sure that it is a zero on your behalf.  The remaining digits make up your new U.P.C. Company Prefix, usable only for generating UPC-A barcodes  and a few other less common things (see the GS1 General Specification for what else you can do with a U.P.C. Company Prefix).  For an NDC that has a 4-digit Labeler Code your U.P.C. Company Prefix will now start with a “3” and it will be 5 total digits long.  For an NDC that has a 5-digit Labeler Code your U.P.C. Company Prefix will now start with a “3” and it will be 6 total digits long as shown below.
   

   Click images to enlarge

3. Combine your U.P.C. Company Prefix with the Product Code and Package Size fields from your NDC
   For an NDC that has a 4-digit Labeler Code your Product Code and Package Size fields will be a total of 6 digits long.  Combine them with the GS1 U.P.C Company Prefix by placing them to the right of the prefix.  For an NDC that has a 5-digit Labeler Code your Product Code and Package Size fields will be a total of 5 digits long.  Combine them with the GS1 U.P.C. Company Prefix by placing them to the right of the prefix.  You should now have a total of 11 digits regardless of the length of your Labeler Code as shown in the table below.
   

   Click images to enlarge

4. Calculate the Check Digit and add it to complete your GTIN-12
   GS1 provides an algorithm to calculate the Check Digit in section 7.2.7 of the GS1 General Specification.  They also provide a handy calculator at this webpage(although where they say to enter the “Item Reference”, they really mean for you to enter the full prefix and item reference together).  Add check digit to the right of the code constructed in step 3.  You should now have a 12-digit code as shown below.  This is the GTIN-12 that can be encoded into a UPC-A barcode and printed on your product.
   

   Click images to enlarge

If you look closely at the table above you may see a short-cut that would get you directly to your GTIN-12.  All you need to do is take your 10-digit NDC and put a “3” in front of it and put a calculated check digit at the end as shown in the following table.

Click on images to enlarge

It is true that you can get there this way but then you might be tempted to skip step #1 and not obtain your official GCP.  As I understand it, since GS1 owns a copyright on the UPC family of barcode symbologies they could make a claim against your company if you encode your NDC into the copyrighted UPC-A symbology without first registering your FDA Labeler Code with them and paying whatever fee they place on that.  Talk to GS1 US to get the full story for your particular situation.  On the other hand, if you have already registered your Labeler Code with GS1 US then this short-cut should always produce your GTIN-12 for subsequent products that share the same FDA Labeler Code.

PRESCRIPTION DRUGS:  GTIN-14

Any drug distributed in the U.S. that is regulated by the FDA as a prescription drug must be dispensed by a registered pharmacist.  In that case it will not be scanned at a retail POS station.  For that reason you do not need to encode your NDC within a GTIN-12 but should encode it into a full GTIN-14.  GTIN-14s should also be used on all case labels whether OTC or prescription (see the HDMA Bar Code Guidance for details).  You can render a GS1 GTIN-14 identifier into a GS1-128, GS1 DataMatrix, or GS1 DataBar symbology depending on the application.

Here is what you need to do to properly convert your NDC into a GS1 GTIN-14 data structure:

1. Register your FDA Labeler Code with GS1 US who will convert it into a GS1 Company Prefix (GCP) and grant you the right to use it
   This is the same as step #1 for GTIN-12 above.
   
   
2. Combine your GS1 Company Prefix with the Product Code and Package Size fields from your NDC
   For an NDC that has a 4-digit Labeler Code your Product Code and Package Size fields will be a total of 6 digits long.  Combine them with the GS1 GS1 Company Prefix by placing them to the right of the prefix.  For an NDC that has a 5-digit Labeler Code your Product Code and Package Size fields will be a total of 5 digits long.  Combine them with the GS1 GS1 Company Prefix by placing them to the right of the prefix.  You should now have a total of 13 digits regardless of the length of your Labeler Code.
   
   
3. Calculate the Check Digit and add it to complete your GTIN-14
   GS1 provides an algorithm to calculate the Check Digit in section 7.2.7 of the GS1 General Specification.  They also provide a handy calculator at this webpage.  Add check digit to the right of the code constructed in step 2.  You should now have a 14-digit code.  This is the GTIN-14 that can be encoded into a GS1 Code-128, GS1 DataMatrix, or DataBar barcode and printed on your product or case.  (NOTE:  DataBar should only be used on packages that are too small to accept one of the other symbologies.  See the HDMA Bar Code Guidelines for details.)

Finally, if you have already registered your Labeler Code with GS1 US you can use the following short-cut to construct your subsequent GTIN-14s.

Click image to enlarge

The following figure summarizes the contents of all forms of the NDC for both GTIN-12 and GTIN-14 data structures.

Click images to enlarge

IMPLICATIONS

There is an important implication stemming from the use of GS1 identifiers and barcodes to encode and render your NDC that I think needs to be explained.  This applies to any company that already possesses a GCP that does not match their FDA Labeler Code.  I can think of two ways that this might happen:

1. Any company in the U.S. that distributes non-drug products and already obtained a GCP from GS1 US for those products,
2. Any drug manufacturer that is based outside of the United States and that already possesses a GCP that was issued by their local, non-U.S. GS1 Member Organization.

Neither of these types of GCP’s can be used to encode an NDC for distribution within the U.S.  That’s because these GCPs do not match your FDA issued Labeler Code.  Only GS1 US, the U.S.-based GS1 Member Organization, can issue you a GCP that is properly based on your Labeler Code.  So these companies should contact GS1 US to register their Labeler Code, whether the company is based in the U.S. or not.

Systems and their associated databases should always be designed to accommodate the full GTIN-14 even when the application may seem to only need to deal with GTIN-12′s.  See GS1′s position paper on this topic for more explanation.

There are a few more “Anatomy of…” essays I want to write including the FDA’s Standardized Numeric Identifier (SNI), and GS-128 in the U.S. Pharma supply chain.  Watch for those essays in the near future.

Dirk.

2012 is the year of the GTIN in the U.S. healthcare supply chains as christened by the largest hospital group purchasing organizations (GPOs) in their so-called “Sunrise 2012″ program.  They have asked all of their suppliers to switch from proprietary product codes to GS1’s Global Trade Item Number (GTIN) standard in catalogs, B2B communications and shipment labeling by the end of this year.  They did the same thing with GS1’s Global Location Number (GLN) back in 2010 (“Sunrise 2010″) but so far it appears to have had only a small (but still growing) impact.

The GTIN can be a mysterious concept.  I received an email recently from a sales person who wanted to know what this “G-ten” thing was that her customer kept claiming was so important to her future business with them.  I’ve also sometimes had difficulty convincing people that GTIN adoption is important.  “We don’t need another product identifier.  We already have the NDC!”

I hope to pull back the veil just a little bit and explain not only the anatomy of the GTIN but also why it is so important to all supply chains in all regions of the world.

WHAT EXACTLY IS A GTIN?

GS1 explains the GTIN this way:

“As the name implies, the GTIN helps automate the trading process – basically buying and selling.  GTINs are therefore assigned to any item (product or service) that may be priced, or ordered, or invoiced at any point in any supply chain.  The GTIN is then used to retrieve pre-defined information about the item.  The key benefit is that information about the item can be retrieved about the product from the GTIN whether it is read in a GS1 BarCodes symbol, exchanged via a GS1 eCom message or accessed from the Global Data Synchronisation Network.”

Hmmm…Let me try.  First, a “Trade Item” is any product or service that may be manufactured, priced, advertised, bought, sold, traded, invoiced, returned or consumed within a commercial supply chain.  GTIN (Global Trade Item Number) is a GS1 standard that defines the structure and usage rules for a numeric identifier that can be assigned to a very specific, idealized description of a “trade item” and which can then be used in any part of the world to refer to instances of trade items that conform to that description.

For another attempt at a definition, see the one on Wikipedia here.

In everyday usage “a GTIN” is the number that is encoded into the product barcodes found on pretty much every product you can find in any store.  In the U.S. you know it as the UPC, or Universal Product Code, a 12-digit number (and technically known as a GTIN-12).  In the E.U. you know it as the EAN, or European Article Number, a 13-digit number (and technically known as a GTIN-13).  The GTIN-12 and GTIN-13 are “retail” GTINs.  That is, these are the GTINs placed on products that are typically sold through a retail Point of Sale (POS) station (a store checkout counter).  This includes most over the counter (OTC), non-prescription drugs.

Today, nearly all OTC drugs and many prescription drugs in the U.S. supply chain are marked with a National Drug Code (NDC) or a Universal Product Code (U.P.C.) that is encoded in a GTIN-12 data structure and rendered on the package in a UPC-A barcode.  Non-retail products like those that are typically sold only B2B (business to business) (GS1 refers to these as “Trade Items Intended for General Distribution Scanning Only”)—including prescription pharmaceuticals—should be assigned a 14-digit GTIN (technically known as a GTIN-14).

You may yawn, but this is powerful stuff if you can get everyone on the bandwagon.  The GPOs in the U.S. and GS1 plan to do just that.

The most important aspect of the GTIN standard is that when one is properly assigned to a given product or service it is globally unique.  That means that no other product or service anywhere in the world can ever be assigned that same GTIN so that number can be used anywhere and everywhere to refer to that specific type of product or service.  This eliminates product code ambiguity globally.

Another important feature is that the GTIN standard is applied in the same way regardless of product type, service type or supply chain.  The same rules apply to all GTIN identifiers.  These rules are defined in GS1’s General Specification—the specification of “The GS1 System”, of which GTIN is just one part.  See also “GS1 GTIN Allocation Rules for Healthcare” for some of these rules in a healthcare context.  (For a great non-technical explanation of “The GS1 System” of standards, check out this great PDF:  “The Value and Benefits of the GS1 System of Standards”.)

ANATOMY OF A GTIN-14

I mentioned above that a GTIN can take form in 12, 13 or 14 digits (it can also take the form of an 8-digit value but that’s very rare in healthcare), but since my focus is primarily in the B2B healthcare supply chains I’m only going to concentrate on the 14-digit form in this essay.  This is the only form that will fit into barcodes that make use of GS1 Application Identifiers (AI) (like GS1-128 linear barcodes and GS1 DataMatrix 2D barcodes) although the other forms can always be converted into the 14-digit form (by padding with zero[s] on the left).  Note that OTC drugs at the unit-level cannot make use of the GTIN-14 structure, AIs or the barcodes that carry them because they need to be scanned at POS.

There are four components that make up a GTIN-14 and they appear in this order:

• Indicator Digit
  This digit only appears in the GTIN-14 and is primarily used to indicate standard groupings (inner pack, case, pallet, etc.) of packages of the same GTIN using values 1 through 9.  A zero indicates that the GTIN is representing a single unit.  For products where the actual units sold can be a variable measure (weight, size, volume, etc.) the indicator digit should be set to 9.  Indicator values 1 through 8 have no specific standard meaning other than that they indicate a grouping.  That is, there are no standard groupings that values 1 through 8 may indicate so you can’t assume any particular value means an inner pack, a case, a pallet or anything else.  Each company is free to choose any of these values to indicate any grouping they wish.
  
  
• GS1 Company Prefix (GCP)
  This is the variable length number that is assigned by the local GS1 Member Organization (MO) to the company that manufactures, packages or repackages the product that the GTIN represents.  This is the number that those companies must apply to GS1 for assignment.  In the U.S. the GCP ranges in length between 6 and 10 digits and the length partially determines its cost.  Shorter company prefixes cost less than longer ones (see Item Reference below for why this is so).
  
  Pharmaceutical companies who already possess an FDA Labeler Code (see my previous essay, “Anatomy Of The National Drug Code” for more on this) just need to register that code with GS1 US (the local GS1 MO in the United States) to obtain a license to use that same code as the basis for their GCP within the context of GS1’s copyrighted barcode, RFID, EDI, pedigree and track & trace standards.
  
  The GS1 Company Prefix is itself composed of a 1 to 3 digit GS1 Prefix which is assigned by the GS1 Global Office to each GS1 MO to ensure global uniqueness of all GCP-based GS1 keys (GS1 keys include GTIN, GLN, SSCC, GRAI, any EPC, GSRN, GIAI, GDTI, GSIN, etc.).  This prefix is sometimes incorrectly referred to as a “country code” although because MOs are fairly country-specific this is not too far off.  The remainder of the GCP—known as a Company Number—is assigned by the Local MO.  See the GS1 General Specification for more details.
  
  When a company is assigned a GCP by GS1 they are granted exclusive rights to use that prefix to construct any of the GS1 keys (see the list in the paragraph above) and use them in any way they see fit as long as it is within the rules established in the GS1 General Specification.  GS1 keys generated by the owner of the GCP do not need to be authorized, approved or registered with GS1.  There is no additional cost to generate new GS1 keys once a company obtains a GCP.
  
  GCPs are a company asset that should be addressed in any merger or divestiture strategy (see this topic in the GS1 General Specification).  GCP usage within a given company should ideally be controlled at a single point within an organization.  This generally isn’t an issue for smaller companies but multinational corporations should ensure that they have a strategy for centrally assigning and distributing GCP-based GS1 keys to their operations to ensure uniqueness and to ensure that the GCP resource is used to its maximum potential.
  
  Companies may obtain multiple GCPs from their local GS1 MO if they use up the available reference values in one or more GS1 keys.  They may also obtain additional GCPs (partly “used”) as the result of a merger with another company.
  
  Neither GS1 nor the MOs police adherence to any of their standards, but they carefully control the assignment of GCPs to always maintain global uniqueness.  As long as the GCP assignments are all globally unique, all of the keys generated by the owners of all GCPs will also be globally unique.  This is a very important design feature of the entire GS1 System.
  
  
• Item Reference
  The Item Reference is a variable length number that must be chosen by the owner of the GS1 Company Prefix and assigned to the specific description of a single product class.  This specific description must remain unchanged for the life of the GTIN (see the GS1 General Specifications for details and exceptions).  The combination of the owner’s GCP and the Item Reference must be exactly equal to 12 digits.  Since the length of the GCP is determined when it is obtained from the local MO, the length of the Item Reference must take up the remainder of the 12 digit space.
  
  For example, if company A obtains a 6-digit GCP, the Item Reference field within their GTIN-14′s must be 6 digits long (12 – 6 = 6).  If company B obtains a 10-digit GCP, their GTIN-14 Item References must be only 2 digits long (12 – 10 = 2).  From these two examples you can see that company A can identify up to 1,000,000 unique products or services but company B can only identify 100.
  
  There is a comparable limitation in the other GS1 keys.  Shorter GCPs result in more digit space available in the reference portion of the key which results in vastly more usable unique numbers (each extra digit represents an order of magnitude more unique values the owner can assign).  This is why GS1 charges more for the shorter GCPs than they do for longer ones and this provides a measure of affordability to smaller companies who will likely never need more than a small number of unique GTINs or other keys.
  
  
• Check Digit
  The Check Digit is a single digit that is mathematically calculated based on the contents of all of the other digits in the GTIN-14.  The purpose of the Check Digit is to help barcode readers and applications detect data entry errors.  See Section 7.10 of the GS1 General Specification for the algorithm.

EXAMPLE GTIN

Here is an example of a GTIN-14 that I found on an inner-pack of Epinephrine injectors.

Click image to enlarge. Image Copyright RxTrace 2012.

An “inner-pack” is a grouping of trade items and so we see the Indicator Digit is set to “1″, a valid value for a grouping.  We can’t tell by looking at this example exactly how long the GCP is because it could be anywhere from 6 digits to 10 digits long.  Fortunately GS1 provides a service they call Global Electronic Party Information Registry, or GEPIR.  If we select “Search by GTIN”, enter ’10304094921348′ and click “Search”, we are told that this GTIN contains a 6-digit GCP of ’030409′ and it is registered to Hospira, Inc. in Lake Forest, Illinois.  Now we know that the Item Reference that Hospira happened to choose for this GTIN must be ’492134′.  The Check Digit is calculated based on all of the previous digits as “8″.

This particular inner-pack contained about 10 or 12 unit-level packages that were shrink-wrapped together and labeled with the GTIN-14 above.  Each of the units contained a barcode with the unit-level GTIN-14 encoded in it.  It was exactly the same GTIN as the inner-pack except for the Indicator Digit which was correctly set to zero.  These were unit dose injectors.  There are probably about 4 inner-packs per casepack but I didn’t note that information.  The case GTIN would be exactly the same as the inner-pack and units except for the Indicator Digit which would have been been a value in the range of 2 to 8 to reflect that it is a standard grouping that is different than the inner-pack.

Normally we don’t need to deconstruct GTINs like this.  In fact the whole point of a GTIN is to use it as a single whole identifier and not to break it down into its constituent parts like we have done here but I wanted to show you how this one was intelligently constructed by Hospira, the owner of this particular GCP.

BENEFITS OF THE GTIN

The benefits of GTIN adoption by a supply chain are different between manufacturers and non-manufacturers (distributors, pharmacies and retailers).

Manufacturers gain because they can potentially use the same standard product/service identifier in multiple markets/countries.  Well, as long as the packaging doesn’t vary (same language, etc.) and there aren’t any regulatory reasons for using a different identifier (national numbering like the U.S FDA NDC, different units for the unit of measure, etc.).  Even when a different identifier is necessary for different markets/countries the manufacturer benefits from the use of a standardized identifier because modern Manufacturing Execution Systems (MES), Warehouse Management Systems (WMS),  Electronic Data Interchange (EDI) systems and Enterprise Resource Planning (ERP) systems should come with full GS1 System support built in (admittedly not all do yet).  This includes enforcement of many of the GS1 rules for dealing with GTINs and the other pertinent GCP-based identifiers.

Like manufacturers, non-manufacturers in the supply chain make use of WMS, EDI and ERP systems in addition to pharmacy management systems and  Hospital Materials Management Inventory Systems (HMMIS) that ought to have standardized GS1 System support built in.  These companies also benefit because they can trust that GTINs are globally unique and all product identifiers used by all of their suppliers refer to the same product or service and those identifiers are constructed using the same format.  This allows them to eliminate their own internal product codes for each manufacturer’s products and services, simplifying inventory management, sales, purchasing, order fulfillment, shipping, receiving and dispensing and thus reducing errors that generate waste and in the healthcare supply chain can cause injury or even death.  This is why the GPOs are so hot to make 2012 the year of the GTIN.

ADOPTION OF THE GTIN

Manufacturers of products or services can decide to unilaterally adopt the GS1 GTIN standard for all of their products and they can reap some small internal benefits from that decision as I’ve outlined above.  That may not offer enough of a gain to offset the cost of conversion from proprietary product identifiers.  The problem is, for the downstream trading partners to benefit from GTIN use, more than just one manufacturer has to switch to GTINs.  In fact, the benefits don’t start accruing to those companies until a significant number of manufacturers switch to GTINs, and until all manufacturers in a given supply chain switch to them the benefits do not reach their maximum potential.  For this reason, GTINs should be adopted by a supply chain as a whole and not just one company here and there.

How do you trigger a switch within an entire supply chain like that?  The GPOs may have it figured out.  Like Walmart in the fast-moving consumer goods (FMCG) supply chain and the big automakers in their supply chain, they have to start dictating the switch and they have to be hard-nosed about it.  Can the GPOs fill the role of the “800-pound gorilla” like Walmart and the automakers?  We’ll see.

There are some encouraging signs and some discouraging signs in the recently released results of a survey in a document called “GS1 Data Standards Adoption Survey, Progress toward Global Trade Item Numbers (GTINs), December 2011” conducted by the University of Arkansas Center for Innovation in Healthcare Logistics (CIHL) on behalf of the Healthcare Supply Chain Association (HSCA) (the industry association of GPOs, formerly HIGPA) and the Healthcare Industry Supply Chain Institute (HISCI).  I’ll have more to say about this paper and the results it documents in a future essay.

I’ll stop here for now.  Watch for future related essays on “Depicting an NDC Within a GTIN”, and “Anatomy of an SNI”.

I am going to attend the 2012 National Pharmacy Forum in Tampa on February 9th.  The full conference runs from the 8th through 10th and is co-hosted by HCSA and HISCI.  If you run into me there please introduce yourself and tell me what you like and don’t like about RxTrace.

Dirk.

GS1 EPCglobal ratified and published the most recent version of the Tag Data Standard (TDS), 1.5.  I have always been a fan of TDS, but earlier versions served as much to expose embarassing disconnects in GS1 standards as they did to explain how to apply GS1 identifiers in an Radio Frequency IDentification (RFID) context.  Earlier versions of TDS tightly bound the concept of the Electronic Product Code (EPC) to RFID, and that’s just wrong.  “EPC”, even as defined in those earlier versions of TDS, is a way of uniquely identifying objects on a global basis.  It’s purely a globally unique identifier standard.  That’s a hugely important and relatively new concept.  RFID–a simple data carrier technology that’s been around for many years–is almost insignificant in comparison.

Even the name “Tag Data Standard” reflects this wrong-headed binding of EPC to RFID by seeming to place the RFID “Tag” at the center of the “standard”.  Yes, there is a need for a “Tag Data Standard”, to show how to encode an EPC into an RFID tag, but it is wrong to hide the definition of the EPC inside such a limited specification.  EPC is carrier technology independent.  RFID is only one of several carrier technologies that can carry EPC information. 

This disconnect between the standard and reality has caused a lot of confusion, even within GS1 where people seem to fall into one of two catagories distinguished by either bar codes or RFID.  People from both worlds within GS1 have assured me that and EPC can only be encoded into an RFID tag.  They are wrong, and GS1 would be a better organization if everyone associated with it would study the EPC and think about what it means to GS1 and its users.  I think it would expand their minds.

But finally, in TDS 1.5 it is made clear…  

“Nevertheless, it should always be remembered that the EPC and RFID are not at all synonymous: EPC is an identifier, and RFID is a data carrier. RFID tags contain other data besides EPC identifiers (and in some applications may not carry an EPC identifier at all), and the EPC identifier exists in non-RFID contexts (those non-RFID contexts including the URI form used within information systems, printed human-readable EPC URIs, and EPC identifiers derived from bar code data following the procedures in this standard).”

Now GS1 needs to update a lot of their documentation to reflect this reality.  Much of it continues to perpetuate the tight linkage of EPC and RFID.  See this FAQ for example.

This separation of EPC and RFID is pertinent in the pharmaceutical supply chain right now because many companies are planning to apply globally unique serial numbers to their products to comply with regulatory requirements in countries like Turkey, Brazil, Italy and in states like California.  At the same time most of them are also planning to apply globally unique serial numbers to their cases, pallets and totes.  The companies I am aware of are currently planning to use GS1 EPC’s for these serial numbers, but, as I predict in “RFID is DEAD, at Unit-Level in Pharma“, most will not use RFID to carry those numbers, but will use 2D barcodes instead.  A few will use RFID and 2D barcodes to carry a single EPC.  None of these uses would be possible if the EPC wasn’t fully distinct from the carrier technology.

TDS 1.5 IS A MASTERPIECE…BUT…

Yes, TDS 1.5 is a masterpiece.  For the first time there are separate sections for the EPC and for RFID as a carrier technology of EPC’s, and it is written in a way that is very easy to understand.  This version also includes clear information about encoding GS1 element strings into EPC’s.  GS1 element strings are values that are typically encoded into barcodes.  But if it were up to me in the future, GS1 would entirely remove the specification of the EPC from TDS.  There would be an EPC Standard, a Tag Data Standard (let’s call it TDS 2.0), and a Barcode Standard.  Or perhaps they should keep all carrier technologies in a single standard.  I’d call it the “EPC Carrier Standard” and it would have an RFID section and a barcode section.  It would show how to encode any EPC into one carrier technology or the other and how to convert from one to the other without data loss or ambiguity.  TDS 1.5 is very close to this ideal.

It seems simple and the need is great because pharmaceutical companies are moving forward right now, but GS1 has been grappling with RFID and bar code interoperability for quite a few years.  TDS 1.5 goes a long way toward resolving these issues, but full resolution is still ahead of us.  Oh well, maybe TDS 1.6 will be an even better masterpiece.  Watch for it to arrive sometime next year.

WHAT IS THE EPC AND WHY HIBCC SHOULD PAY ATTENTION

The EPC standard, encased inside of the RFID-Tag Data Standard 1.5, is so simple that it’s not surprising that people miss it.  Section 4 of TDS 1.5 expresses it this way:

“The EPC is a universal identifier that provides a unique identity for any physical object. The EPC is designed to be unique across all physical objects in the world, over all time, and across all categories of physical objects. It is expressly intended for use by business applications that need to track all categories of physical objects, whatever they may be.”

The most likely systems to recognize and operate on EPC’s are those that are based on the GS1 Drug Pedigree Messaging Standard (DPMS, a.k.a., the GS1 Ratified Pedigree Standard), or the GS1 EPC Information Services (EPCIS) standard.  Both of these standards specifically work with EPC’s.  DPMS, of course, is specificly designed for compliance with U.S. electronic document-based pharmaceutical pedigree laws like California, Florida and the federal PDMA.  EPCIS is an interface standard for use in systems that focus on documenting object visibility in a supply chain.  The future GS1 Discovery Services standard will also operate on EPC’s.

I assume that GS1 has copyrighted the acronym “EPC”, but what’s interesting is that there is nothing special–nothing GS1-specific–about creating an object identifier that can be used in systems based on DPMS or EPCIS.  That’s because those two standards simply require the use of unique identifiers that follow a set of open W3C standards, specifically RFC2396 (see also RFC2141 and RFC3406).  GS1 refers to this as an identifier in “pure identity” format, which is also known as “URN” format (“URI format” to purists).

For example, a valid identifier for use in DPMS or EPCIS for an object serial number that I took from TDS 1.5 is:

urn:epc:id:sgtin:0614141.112345.400 

GS1 was issued the namespace “epc” by the Internet Assigned Numbers Authority (IANA) and that gives them the authority to define the schema for all of the data elements to the right of the letters “epc:” in the identifier above.  TDS 1.5 specifies what each of those segments mean and their value ranges.

But DPMS and EPCIS would work just as well if the object’s unique serial number were defined with some other valid URN: namespace besides “epc:”.  Nothing stops organizations (like the Heath Industry Business Communications Council, HIBCC) from acquiring their own namespace from IANA and defining their own schema that would encode their own unique, non-GS1 serial numbers.  And those URN: formatted (URI formatted for the purists) unique identifiers would work just as well and would be fully interoperable with other “URN:EPC:” serial numbers.  Of course, just don’t call them EPC’s.

For many types of commercial objects, there are no viable alternatives to GS1 numbering so use of GS1 EPC’s are a given.  But whenever medical products are serialized at some time in the future, GS1 is only the latest entrant (though growing fast as I point out in “WAR: GS1 Vs. HIBCC“).  HIBCC was the traditional numbering not-for-profit organization for these type of devices and they recently introduced their own approach to unique identification based on their Labeler Identification Code (LIC) and an added serial number.  Like GS1, they hid it inside of their RFID specification.

With version 1.5, TDS has gone through an impressive rewrite.  It’s easy to read, especially the first 6 sections (23 pages).  I highly recommend it to anyone wishing to better understand the EPC standard at the conceptual level.

In the healthcare supply chain a significant number of hospital group purchasing organizations (GPO’s) have stipulated, to varying degrees, that their suppliers begin making use of GS1 Global Location Numbers (GLN’s) in all of their trade with their member hospitals by the end of 2010 (Sunrise 2010) and GS1 Global Trade Item Numbers (GTIN’s) by the end of 2012 (Sunrise 2012).  Here are the announcements from Novation, Premier, MedAssets and Amerinet.  From the wording of their announcements it appears that you have little choice, especially if you have competitors who are planning to comply with their requirements.

Companies who supply these hospitals are faced with how to comply with those requirements.  The best advice I can give to companies that are facing these requirements is to contact the respective GPO offices and get their specific direction.  Each GPO may have a different interpretation of their own requirements.  GS1 U.S. is the second place you can go for additional information about the proper way to establish the necessary capability in your IT systems.

Here is a list of questions you may want to ask of each GPO to help you understand what you have to do to comply:

1. Do they require the use of GLN’s in addition to HIBCC’s Health Industry Number (HIN) or instead of it?
   
   
2. Do the GTIN requirements only cover medical devices or does it include everything a hospital purchases including pharmaceuticals and over-the-counter (OTC) products?  Does it include implants?  As I understand it, most implants currently use HIBCC product codes because they use alphanumerics which offers an expanded number of possible codes.  I’ve heard people speculate that the GPO requirements only cover medical devices, but when I read their announcements it sounds to me like they mean everything they purchase.
   
   
3. Are the 2010 and 2012 dates the earliest time you are allowed to begin using GLN’s and GTIN’s respectively in transaction documents, or can you begin using them as soon as you are ready?  In other words, can the GPO assure you that their member hospitals are ready to accept them whenever you are ready to supply them, or do you have to wait until the actual sunrise date, or worse, selectively turn on the capability, one hospital at a time, as they become capable of receiving them?
   
   
4. If you have every intention of making the necessary system changes to comply, but you just can’t get the resources necessary in time (remember, GLN by the end of this year), can you continue to do business with the member hospitals after the sunrise dates?  This is a test of how “hard” these deadlines really are.
   
   
5. The point of GLN’s and GTIN’s is to allow you to remove all of the supply chain master data (SCMD) elements that are associated with these numbers from all transaction documents.  But it’s unclear if that’s what the GPO’s are really asking for.  SCMD elements for GLN’s include things like the company name, street address, phone numbers ,etc.  SCMD elements for GTIN’s include things like the product name, size, color, form, weight, temperature requirements, etc.  Do they expect you to remove all of the master data elements that are associated with your GLN’s and GTIN’s from your transaction documents (printed and electronic), or do they want to keep all of that data in your documents, but just add the GLN numbers and GTIN numbers?
   
   
6. Do they require you to subscribe to and register your GLN’s in the GS1 U.S. GLN Registry for Healthcare, or can you just provide them with your GLN(s) and their associated supply chain master data?  If they don’t require you to use the GLN Registry, what mechanism will they accept for transmitting your supply chain master data?
   
   
7. Similarly, do they require you to subscribe to a GS1 GDSN data pool and maintain your product’s supply chain master data there?  If not, what mechanism will they accept for conveying your product master data?  (Depending on their answer to #5 above, they may not need you to give them your SCMD, yet.)
   
   
8. What if you are a wholesaler and the manufacturer’s of the medical devices and pharmaceuticals you supply to their member hospitals do not even have GS1 GTIN’s defined for their products but have HIBCC-based product codes instead?  (GS1 GTIN allocation rules prevent you from creating GTIN’s on behalf of the original manufacturers.)  Will the HIBC code fulfill the requirement? 
   
   Be aware that the GS1 U.S. GLN Registry for Healthcare will not accept HIN’s and GDSN data pools will not accept HIBC codes.  Will the GPO’s accept the use of HIBCC’s HIN System database in addition to the GS1 Registry?  Will they accept the use of HIBCC’s UPN Repository in addition to GS1’s GDSN?  Don’t get your hopes up, but these are important questions for you to ask just to get clarity on what is expected of you.

I’m told that many ERP systems are able to define a custom set of item number aliases for each of your customers.  That’s one way to force the use of GTIN’s for each SKU on your transaction documents for GPO members.  Of course, GS1 is hoping you decide to cascade the GPO requirements to all of your internal systems and then to your suppliers as a GPO-like requirement.  That approach would spread the use of GS1 identifiers throughout all of your IT systems that deal with supplier and customer addresses (GLN’s) and item information (GTIN’s).

That might be a pretty big change, but you should evaluate the pros and cons of both approaches before you decide which way is best for you.  One thing to keep in mind is that the Sunrise dates are not regulatory requirements and GS1 has no authority to place requirements on anyone.  At this writing, it’s only a requirement of some GPO’s.  On the other hand, it’s hard to imagine that the supply chain can achieve a steady state with a mixture of HIBCC and GS1 location and product identification codes once the GPO mandates are operational.  More than likely the switch from HIBCC standards to GS1 standards will accelerate until only GS1 remains.

GS1 U.S. RESOURCES

GS1 U.S. has prepared a number of documents to help GPO suppliers meet the Sunrise requirements.  Most of them can be found in the GS1 U.S. Healthcare Document Library.  I’ve already provided hyperlinks to some of these resources above but here are a few more that you will find helpful:

• JUST RELEASED!  2010 GLN Sunrise Explained:  Industry Implementation Plan 
• Mayo Clinic – Cardinal Health GLN White Paper
• GS1 U.S. Healthcare Industry Sunrise Dates web page with links to toolkits and white papers
• Introduction to GS1 Standards in Healthcare
• GS1 U.S. Healthcare web site

SO YOUR SUPPLIER HAS ANNOUNCED THAT THEY ENDORSE GS1 STANDARDS, WHAT DOES THAT MEAN TO YOU?

At least one medical products wholesaler has recently stated that they endorse GS1 standards, specifically GLN and GTIN.  See a copy of their statement on page 3 of this report.  It appears that they are not requiring their suppliers or customers to support these standards, but if you are from a company who buys medical supplies from a company who has made an announcement like this and you prefer to continue using HIN for location codes and HIBC product codes, make sure you read their statement yourself and decide what it means to you.  If you have any questions you should contact them directly.

WHY ARE COMPANIES MAKING THESE ANNOUNCEMENTS ANYWAY?

There are two primary goals that underlie the movement to GS1 identifiers in the healthcare supply chains:  Patient Safety and Efficiency.  In my observation, companies who have decided to throw their weight behind the GS1 sunrise dates are doing it to remove as much ambiguity as possible from supply chain transactions.  Ambiguity is the enemy.  Ambiguity causes inefficiencies and it can harm patients, or worse.  And we have tolerated way too much ambiguity in the supply chain for too long.

Most of the ambiguity in the healthcare supply chains today occurs when companies use different master data than their trading partners are using for the same product or location.  That is, each company is maintaining their own local master data (MD) for each product code and each customer and supplier location.  They are using MD when they should be using Supply Chain Master Data (SCMD).  SCMD removes ambiguity because there is a single version of the truth across the entire supply chain for each product and location.  With SCMD, there is only one company responsible for maintaining the master data for each identifier on behalf of the entire supply chain, and that company is the owner of the data.  That is, each manufacturer is responsible for maintaining the SCMD for the products they manufacturer, and all of the other companies in the supply chain are provided that data, along with each update as soon as it occurs.  The same for each location in the supply chain.

GS1’s standard for the synchronization of supply chain master data (SCMD) is Global Data Synchronization Network (GDSN).  So why are we hearing about requirements for the adoption GLN and GTIN and not for GDSN?   The reason is simple.  The adoption of GS1’s GDSN standard for the synchronization of supply chain master data (SCMD) can only occur when there is a surge of trading partners who agree to implement it all at once, and who then put pressure on their other trading partners to adopt it at the same time.

It’s a very high threshold that must be overcome before GDSN can provide benefits to the supply chain.  So the first thing you have to do is get your supply chain to use the same standards for product and location identifiers.  That’s a prerequisite to GDSN.  GLN and GTIN are the only identifier standards that work with GDSN so that’s why we have Sunrise 2010 and 2012.  I will be very surprised if we don’t eventually see a Sunrise date issued for the adoption of GDSN by the same GPO’s once the supply chain is using only GLN’s and GTIN’s.  Use of a single standard for SCMD is the least complex way to remove ambiguity, which will finally elevate patient safety and supply chain efficiency, the ultimate goals.

HOW DOES HIBCC FIT INTO THE GLN, GTIN AND GDSN WORLD?

Short answer:  it doesn’t.  As I pointed out in my previous essay, the success GS1 has had in capturing the attention and support of the GPO’s is the biggest blow to HIBCC’s future.  GS1’s standards are currently designed to work only with GS1 identifiers, and that’s unlikely to ever change.  Part of the removal of ambiguity is narrowing the supply chain to a single set of standards and GS1 has the upper hand right now.  The fact that the block that is driving toward GS1 standards is composed of hospitals is significant.  Hospitals are large consumers of medical devices that have traditionally been identified with HIBC codes, more so than pharmaceuticals anyway.  Once that domino falls, it’s hard to imagine where HIBCC’s support will come from.

This is not my last word on the war between GS1 and HIBCC but I’m not sure if I will have time to complete the subject before the FDA releases their Serialized Numeric Identifier (SNI) guidance, which is due by the end of this month.  I hope to post my thoughts on SNI shortly after they publish.  Watch for it.

Dirk.

For more RxTrace essays related to this topic see:

• “WAR: GS1 Vs. HIBCC “
• “Anatomy of a GTIN“,
• “FDA Aligns with GS1 SGTIN For SNDC “,
• “Updated HDMA Bar Code Guidance: A Must Read “
• “Anatomy Of The National Drug Code“.

That’s right.  GS1 and HIBCC are in a multi-year fight over the dominance of their standards within the U.S. healthcare supply chain.  The U.S. healthcare supply chain is split into two chains:  pharmaceuticals and medical devices.  While the FDA regulates both supply chains and many companies participate in both, there are differences in the standards that have been used historically in each.  The biggest differences are in the unique product identification and location identification.  

HEALTHCARE PRODUCT CODE STANDARDS

FDA created the National Drug Code (NDC) system back in 1972 and mandated its use for all drugs.  At the same time, FDA also created a compatible numbering system called the National Health Related Item Code (NHRIC) for devices but it was apparently voluntary and is apparently now obsolete.  FDA is currently working on the definition of a new numbering system for devices—known as the Unique Device Identification (UDI) system.  The development of the UDI system was one of the initiatives kicked off by the Food and Drug Administration Amendments Act of 2007.  Until UDI is complete, identifiers used for medical device have not been governed by the FDA so companies have been left to make their own decisions about them. 

The U.S. Department of Defense (DoD) didn’t like this situation because it caused confusion in their product ordering and receiving so in 1995 they created the Universal Product Number (UPN) system for medical devices.  They defined a UPN in such a way that the product numbering systems of two competing industry standards organizations could be used.  The Health Industry Business Communications Council (HIBCC) applied their Labeler Identification Code (LIC), and the Uniform Code Council (now GS1 U.S.) applied their GS1 Company Prefix (GCP) as the basis of their UPN’s.  HIBCC appended their 4-alphanumeric-character LIC with a 1 to 18 alphanumeric character product code to form their UPN.  GS1 appended their variable length numeric GCP with a variable length numeric product code to form their 14-digit UPN (also known as a Global Trade Item Number, GTIN-14).  A company must pay a fee to HIBCC if they want to obtain a LIC and a fee to GS1 U.S. if they want to obtain a GCP.

Because the DoD doesn’t need to buy every possible type of medical device, not all devices currently passing through the U.S. supply chain have a DoD-compliant UPN.

HEALTHCARE LOCATION CODE STANDARDS

HIBCC and GS1 U.S. also compete in the healthcare location code standards arena.  HIBCC has the Health Industry Number (HIN) standard and GS1 has the Global Location Number (GLN) standard.  The HIN and GLN differ in multiple ways.  First, the HIN is composed of nine alphanumeric characters assigned by HIBCC, while the GLN is 13-digit number composed of the same GCP found in the GTIN UPN plus a Location Reference that is selected by the owner of the GCP.  It’s an important difference that HIBCC assigns the entire HIN because it means that there is a single point of control for these numbers.  Because each end-user company can define their own GLN’s, GS1 U.S. has to have a GLN registry so that companies can find the GLN’s for their trading partners.  It’s called the GS1 U.S. GLN Registry for Healthcare.

The funding of the HIN and GLN systems are another important difference because of what results.  The assignment of HIN numbers is done by HIBCC for each manufacturer, wholesaler, pharmacy and provider location in the supply chain without those organizations requesting it.  The cost of this “automatic” number assignment is covered by HIBCC.  GS1 GLN’s are only defined when a GS1 GCP subscriber decides to create one.  This means that companies who already own a GCP do not have to pay additional fees to create GLN’s for their locations.  (GS1 also sells individual GLN’s for a lower fee for smaller companies who do not need the full capability of a GCP.)  HIBCC does not charge for listing a company’s HIN’s in their HIN databases, but they do charge for access to those databases.  GS1 charges a fee to list and access their GLN registry.  For these reasons, the HIBCC HIN databases should contain the HIN’s for every location in the entire healthcare supply chain, but the GS1 U.S. GLN Registry for Healthcare will contain only those locations for companies who choose to pay for a GCP or an individual GLN, and who choose to pay to be listed in their registry.  Currently, that’s not as many companies.

One of the problems with industry reliance solely on the GS1 GLN for location identification is that smaller companies, like independent pharmacies, are unlikely to bother acquiring a GCP or a GLN.  Industry reliance solely on the HIBCC HIN doesn’t have this problem because smaller organizations don’t have to pay anything or initiate any action whatsoever for a HIN to be created for their locations.  HIBCC does that on their behalf.

HIBCC was originally formed with the purpose of developing standards for use in the medical devices side of the healthcare supply chain.  On the other hand, the HIBCC HIN was widely adopted on both sides of the supply chain.  GS1 GTIN’s have be used in the pharmaceutical side for many years because early on, GS1 reserved the FDA Labeler Code number space used as the basis of the NDC within their GCP number space.  Pharmaceutical manufacturers still had to register their Labeler Code and pay a fee to GS1 before they used their FDA Labeler Code as a GCP, but this reservation ensured that there would not be any clashes in the future.

STANDARDS WAR

In the title of this essay I called it a war.  That’s not much of an exaggeration.  In my observation, what is going on right now between HIBCC and GS1 is aimed at the total elimination of the other.  GS1 is usually the aggressor and HIBCC is usually found in a defensive posture.  There is lots of evidence of this on the internet.  Here are a few pieces I have found. 

• Check out the opinion of the “Editor” in his/her remarks at the top of this Loftware Blog post from last year.  Yow, that’s blunt. 
• Here is a copy of an article called “Standards Movement Shifts Toward GS1 Version”, from a March 2009 edition of the Hospital Materials Management Newsletter that is hosted on the HIBCC website.
• Here is a HIBCC newsletter from 2008 that contains multiple articles about the war from HIBCC’s perspective.  In fact, most of the articles in the issue take up various aspects of the war.
• Here is a recent article about the HIBCC Vs. GS1 “debate” from the February 2010 edition of Repertoire Magazine called “Is One the Loneliest Number?”.
• Perhaps the salvo that GS1 has made that is the most harmful to HIBCC is their success in getting multiple large hospital group purchasing organizations (GPO’s) and other healthcare organizations to announce that they are adopting/embracing GS1 standards—presumably at the expense of HIBCC standards.  GS1 is rightfully so proud of these and other related announcements that they have collected links to them all on a single page.
• The GPO’s have established two programs designed to push the supply chain to adopt GS1 GLN’s and GTIN’s on an aggressive schedule.  These are Sunrise 2010 for GLN and Sunrise 2012 for GTIN.  GS1 promotes these programs at every opportunity, but they carefully point out that these are not GS1 programs but those of “organizations and companies throughout the U.S. healthcare supply chain”, yet you can’t find anyone else who claims to own them.  Obviously GS1 owns them, but for some reason they don’t want to admit it.
• I have covered several aspects of this debate in previous posts.  This one about a flawed AHRMM sponsored survey that clearly favored GS1 and this one about the perceived “rush” to GS1 standards in the healthcare supply chain.
• GS1 has signed “memorandums of understanding” (MoU’s) with a number of other standards development organizations which, in effect, establishes a treaty between them that defines the type of standards that each organization can develop without encroaching on the other.  GS1 has MoU’s with HL7 and ICCBBA.  No such understanding exists between GS1 and HIBCC because there is already too much overlap in their standards.
• In 2008 HIBCC adopted their own RFID standard that follows ISO standards so that it is at least interoperable with GS1’s EPCglobal RFID standards.  See also this.

Will this war ever end as long as both sides are still standing?  Maybe.  If HIBCC is to survive they will have to find a way to co-exist with GS1 standards.  I have an idea that could remove part of the wedge that seems to force companies to think they have to align with one standards company or the other.  I’ll share my idea in a future post.  (See that future post at Masterpiece: GS1 Tag Data Standard 1.5.)

In April of last year VHA, a nationwide network of community-owned health care systems, published a viewpoint essay on their website called “The Track to Improving Health Care will be Built with IT Standards”.  The posting was written by Mike Cummins, Chief Information Officer of VHA, Inc.  In it, he draws a great analogy between the widespread adoption of a standard railroad gauge by railroad companies 150 years ago as part of the U.S. Transcontinental Railway (as set in motion by President Abraham Lincoln), and the potential benefits of widespread adoption of health care IT standards.  Mike points out that some historians believe that the nationwide adoption of a single railway gauge accelerated the evolution of the greatness of the United States.  It’s well worth reading.

I think the problem Mike sees is that there are so many incompatible IT standards in use in the healthcare industry, with different ones in use in different pockets of the industry.  There are too many proprietary approaches in use, and too many standards in use in one segment of the industry that are incompatible with similar standards in use in another.  In effect, it’s a patchwork, yet each user can claim to be using a standard.  This was exactly the case with the railroads 150 years ago as Mike’s analogy implies.  Each railroad company, or groups of companies, had their favorite “standard” gauge, but which standard was “the best”…the one worthy of becoming the national standard?  I don’t know, but I do know they eventually figured it out and settled on a single gauge for the Transcontinental Railroad and that gauge become the defacto standard.  That allowed the country to be connected and, as Mike points out, historians have dawn a direct line from that agreement to economic expansion and eventual greatness.

Mike makes several proposals that I interpret as ways to cut through the patchwork of standards and get the industry to settle, like the railroad companies, on a single standard for some key technologies like Electronic Medical Records (EMR), Health Identification Numbers and Personal Health Records (PHR).  He calls for the broad, mandatory adoption of GS1barcodes, Global Location Numbers (GLN), Global Trade Item Numbers (GTIN) and accelerated plans by the FDA to mandate the usage of Unique Device Identification (UDI).  He calls for the use of part of the federal economic stimulus money to be used for standards development. 

SLEEPY PROPOSAL BECOMES HOT TOPIC

Fast forward to January 6, 2010.  On that date, VHA issued a press release calling for actions by the FDA and the Obama Administration that were the same as the Cummins posting from last April.  The title of the press release is “VHA Inc. and 12 of the Nation’s Largest Health Care Systems Call for Government to Mandate GS1 Data Standards to Improve Health Care”.  The press release did not include Mike’s railroad analogy.  While the Cummins essay didn’t appear to get any response on the internet, the VHA press release was widely copied by many news release websites.

The very next day, ModernHealthcare.com published a brief news article based on the VHA press release titled, “VHA, member hospitals push GS1 standards”.  One day later the same website posted a comment from Ted Almon, President and CEO of Claflin Co., a Rhode Island based healthcare distributor, about the press release.  The subject of Ted’s posted comment is “Why the rush for GS1 standards?”.  In it, Ted, a veteran of past standards development efforts which led to the formation of the Health Industry Bar Code Council (HIBCC), reasons, “Many industries much smaller than healthcare have dedicated SDOs, and I’m not entirely sure a single set of standards would even present any advantage with today’s technology.”  (SDO=Standards Development Organization.)  He asks “…why all of a sudden is there this pressure to choose GS1, and eschew our own SDO, which we control?”.

Why indeed.  I’ve grappled with questions similar to Ted’s for some time now.  I’m not sure I have the answers—especially answers that Ted and others might agree with—but I have some thoughts on the subject.

ARE GS1 OR HIBCC STANDARDS THE RIGHT “GAUGE”?

I think Mike is on the right track (pardon the pun) when he sees similarities between the current standards situation in the healthcare industry and the railroad industry just prior to the adoption of a single track gauge for the Transcontinental Railroad.  Sure, the industry has been able to make do with two different sets of standards, HIBCC and GS1, for quite a few years, but that does cause inefficiencies.  To remove as much cost as possible from healthcare we need to remove as many inefficiencies as possible, thus, wide adoption of a single family of identification standards is important.  In fact, I think adoption of a single family of identification standards in our industry will result in benefits well beyond simple cost reduction, much as the adoption of the single railroad gauge went far beyond it as well.

So which family of identification standards should the industry settle on, HIBCC or GS1?  I don’t know enough about HIBCC standards to provide a full set of pro’s and con’s, but I think perhaps I can cut to the chase by pointing out the following critical differences:

• GS1 standards are truly global, are HIBCC standards?
  Is there a HIBCC affiliate in China? Brazil? Slovenia?  I don’t think so.  GS1 has affiliates—boots on the ground—in over 100 countries.  GS1 standards are receiving increased attention by governments in many places.
• GS1 standards are cross-industry, HIBCC standards are unique to the healthcare industry
  Sure, GS1 is huge in the grocery supply chain, but it’s also huge in the general merchandise supply chain in which retail pharmacies and drug wholesalers participate in a big way.  I think that’s a good thing.
• GS1 standards are more widely adopted than HIBCC standards, even in the healthcare industry
  OK, I’ll grant you that HIBCC’s HIN is currently bigger than GS1’s GLN in the healthcare supply chain, but it’s just one of many location identifiers in use.  GS1’s GTIN is more widely used than HIBBC HIBC for product identification in the healthcare supply chain.  I don’t have an internet link for this bullet.  This one comes from personal observation.

With just these three bullet points I think the picture is pretty clear.  So clear, in fact, that I think, faced with these three points, even the railroadmen from 150 years ago would tell you that the GS1 family of standards are the better candidate for a U.S. standard than the HIBCC family.  In fact, the HIBCC family of standards comes off looking more like just one of the niche railroad gauges that faded away 150 years ago.

SO GS1 WINS?

Does all that mean that GS1 wins and deserves to be selected as the sole family of standards in the healthcare industry?  Maybe, but like many families, there are good relatives and there are bad relatives.  The GS1 location and product identification standards, GLN and GTIN, are not bad, although in my view, there exist unacknowledged but important differences between the allocation rules of GS1 GTINs and those of NDC’s.  I fear that there may be some gotcha’s when using GS1 GTIN’s to carry a regulated identifier, especially when there is no authority who can arbitrate and enforce conformance.  GDSN, EPCIS and even DPMS have problems that need work.  And we don’t know yet how GS1 will implement the Data Discovery Services standard whose development is just getting underway.  Perhaps these are the kinds of things that Ted was talking about when he wrote of the benefits of having “our own” dedicated SDO.

Many people have a problem with the high fees that GS1 charges, making it look as if they are a for-profit company (they are not-for-profit).  I’ve been one of those people in the past but, for the most part, I have come to terms with it and I now recognize that to get the benefits of a truly global family of standards, it’s going to cost some money.  I hope someone is monitoring exactly how the money is being spent, but I now expect that standards development, along with encouraging adoption, is going to have some significant costs associated with it.   The users of those standards should pay for it.  A fully volunteer organization cannot accomplish what GS1 is doing.

So here is where we are.

1. We need a single family of standards to maximize the efficiency of the healthcare industry;
2. From a high level, the family of standards from GS1 seems to have the inside track;
3. But GS1’s family of standards are not yet a perfect fit and some are currently insufficient for use in this industry;
4. The pharma side of the industry is facing a pedigree deadline in 2015 in California where it will be paramount that the industry has this decision well behind them.

Why the rush for GS1 standards?  At least on the pharma side, it’s because we’re behind schedule.

Earlier this year The Association for Healthcare Resource & Materials Management (AHRMM) and the Center for Innovation in Healthcare Logistics (CIHL) at the University of Arkansas published the results of a survey they conducted in 2008 titled “The State of Healthcare Logistics”. The survey polled 1381 healthcare supply chain professionals regarding their “perceptions of cost and quality efficiencies and improvement opportunities within their organization”. I’m always a little skeptical (alright, I’m a lot skeptical) of “perception surveys”, but since this one was focused on the specific supply chain that I’m a member of, I took some interest. This survey included a series of questions about the respondent’s perception of Data Standards, which really caught my eye.

In fact, I’ve been doing a little investigating myself into the competing standards that are related to supply chain master data. My career experience in this area has almost solely dealt with GS1 standards, but that may be because the healthcare part of my career has centered on the pharmaceutical distribution corner of the full healthcare supply chain. If it had been centered on the distribution of medical devices, I would have been much more familiar with HIBCC (Healthcare Industry Business Communications Council) supply chain data standards. I’ve been trying to figure out if the industry needs multiple competing data standards and, if not, which one is a better set: GS1 or HIBCC? And should I consider some other set of standards that I just don’t know about? Are there good reasons to continue the use of either or both sets of standards in our supply chain?

In this light, I turned my attention to the AHRMM/CIHL survey results, hoping to gain some valuable insight. I quickly got stuck on their very first survey question in the Data Standards section (on page 15 of their report):

A. Is your organization moving towards the adoption of a data standards system (such as GS1) in the next five years?

Now this is an amazingly bad survey question that wouldn’t even pass a “survey questions 101” class. It is a classic example of a leading question. One where the desired answer is provided directly in the question itself. But look at the choice of answers!

1. Yes – GS1
2. Yes – Other
3. No
4. Don’t Know

Wow. Clearly this survey is trying to lead the respondents to indicate support for only GS1 data standards, and it worked. Over 50% of the respondents chose answer “1”, over 30% chose answer “4”, and about 20% chose answer “3”. What about answer “2”, indicating support for “other” data standards systems? Only about 3%.

But the authors go further. Here is part of the analysis provided in the report for this survey question:

“The majority of those that indicate that they are moving towards a data standards system other than GS1 do not know which system their organization is moving towards.”

Maybe that’s because they didn’t tell the respondent which “other” systems are out there. I’m assuming that the authors were just a little sloppy and failed to include in the report the additional question(s) that provided them with this extra information.

I wonder what they would have found if they had asked the question this way:

B. Is your organization moving towards the adoption of a data standards system (such as HIBCC) in the next five years?

1. Yes – HIBCC
2. Yes – Other
3. No
4. Don’t Know

My bet is that the results would be nearly the same.

In general, perception surveys don’t deserve much weight. This one provides a perfect example of why, and this one question destroys any remaining credibility this survey could have had. For this reason, this survey contributed absolutely nothing to my own investigation into systems of standards and it answered none of my questions. That’s sad, because I’m sure there are many other people in the supply chain who are having the same thoughts right now, and we could use some solid, unbiased information about the pros and cons of each choice.

This report has inspired me to construct my own perception survey:

C. Which standards organization (such as GS1) is most likely to have directly or indirectly funded the survey that generated Question A.?

1. GS1
2. Other
3. No
4. Don’t Know

D. Which public university (such as the University of Arkansas) should be most embarrassed by the construction of Question A. and the conclusions drawn from it?

1. The University of Arkansas
2. Other
3. No
4. Don’t Know

For more of my essays related to HIBCC, click here.

My favorite pharmaceutical supply chain blog is DrugChannels by Dr. Adam J. Fein (PhD). Dr. Fein started his blog in May 2006. I became a subscriber and regular reader sometime later that year. The focus of DrugChannels is “Pharmacy economics and the pharmaceutical supply chain”, which has often included very rational opinions on the economic viability of various pedigree laws.

My RxTrace blog has only been around for a short time and its focus is “the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance”. This is almost the inverse of DrugChannels. I’d like to think they are complementary but I suppose we can’t judge that until I generate quite a few more posts. Either way, I owe quite a lot to Dr. Fein and DrugChannels because they provided me the inspiration for starting this blog.

In a recent email exchange, Dr. Fein drew my attention to the FDA document, “Safer Medical Products: Investments for Supply Chain Safety and Security”, a 22-page apparent explanation for an increase of $166,433,000 and 346 FTE’s in the FDA’s FY 2010 budget proposal. Part of the increase “…includes investments that will allow FDA to implement new approaches to effectively regulate the safety and security of the supply chain of medical products …”. “Medical products” include human drugs, vaccines, blood and other biological products, medical devices, animal drugs and medicated feed.

New Approaches

The biggest driver of the need for the increase is the rapid globalization of the supply chain for medical products that end up in the medicine cabinets of Americans.

“The priorities proposed in this initiative will assure the safety and security of foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain…”.

“Supply Chain Safety and Security relies on risk-based prevention with a verification-focused approach to hold all segments of industry accountable for ensuring that their products meet U.S. safety standards, with FDA verifying compliance with standards.”

“FDA will increase medical product safety and security by enhancing oversight of entities in the supply chain.”

The proposal promises to hire more experts and modernize FDA information technology. But it also includes funds to fight internet drug fraud, and to allow FDA to develop policy options related to drug importation.

“FDA will develop policies to implement the Administration’s policy of allowing Americans to buy safe and effective drugs from other countries.”

So is the FDA Responsible for Global Supply Chain Security?

Lots of interesting content for everyone to mull over. Daniel R. Matlis, president of Axendia, has done just that in a post on the PharmTechTalk blog. In his post he uses the FDA document to question whether securing the global medical products supply chain should be the FDA’s responsibility or the industry’s. It’s an interesting question and Matlis juxtaposes the FDA paper against comments reportedly made by Gerald Migliaccio, Vice President of Quality, EHS and Agility at Pfizer Global Manufacturing at a recent joint session of the PharmTech Conference and the Manufacturing Execution System in Life-Sciences Congress. Migliaccio believes that, “Supply chain security is the responsibility of all parties involved in procurement/ sourcing, manufacturing, packaging and distribution of raw materials, intermediates and final product.”

Matlis concludes that industry and regulators have different roles in securing the supply chain and that we all benefit by their efforts. After raising such a provocative question, I felt let down by such a milquetoast conclusion. Like Gerald Migliaccio, I believe the responsibility for supply chain security falls squarely on every participant in that chain, global or domestic. FDA is an arm of our government—that which is of, by and for…us, the consumers, the patients. To me, it seems backwards to make the consumer/patient responsible for the safety and security of the supply of products that are advertised as being safe and beneficial to our health and wellbeing.

I’m not arguing against the existence of the FDA, only the argument that it is up to the FDA to ensure the safety and security of the supply chain. What we need from the FDA are standards that ensure that illegitimate supply chain activity can be detected automatically by the supply chain participants themselves. Arming each buyer in every purchase transaction in the supply chain with the means to reliably, quickly and independently verify each prior transaction back to the original manufacturer would accomplish exactly that. I’ll explain how that can be done in future posts.

I’ve written before about the importance of supply chain standards and how pedigree standards can be categorized as “communications standards”. I drew the analogy of the importance of standards in making cell phones work together. Because U.S. cell phone companies agreed to make use of certain standards, you are able to call your friends who chose to buy service from Sprint, when you have chosen to buy your service from Verizon, or any of a number of other U.S. carriers. Without those standards and the agreement of each company to use them, you would only be able to call people who happened to sign up with the same phone company that you did.

I won’t reproduce the whole article here but its contents are just as pertinent today as they were two years ago when it was published in Pharmaceutical Commerce magazine. That article stressed the importance of the GS1 Drug Pedigree Messaging Standard (DPMS, a.k.a. the GS1 Pedigree Ratified Standard), but any approach selected by an individual company to address pedigree legislation has to consider interoperability with whatever approach their trading partners choose. Interoperability is the goal of standards but right now there are two standards-based approaches to pedigree out there and they are not currently interoperable. That’s a problem for everyone, because the supply chain is so interconnected and diverse at the same time.

The two standards are DPMS and EPCIS–both from GS1. The history of these two standards and the differentiating characteristics of each one is too complex to cover in a single post so I’ll just provide an introduction here. I’ll continue the discussion in later posts, although I don’t plan to make the whole thing contiguous because there are other topics that I also want to cover over the same timeframe.

EPCIS (Electronic Product Code Information Services) is a GS1 standard that defines a set of interfaces for the purpose of capturing and querying serial number “visibility” data. “Visibility” data is meant to be observations and transactions that are based on observations of serial numbers that are attached to items and logistical containers of products within supply chains. I still haven’t found an easy-to-understand way to explain it, but I think those two sentences describe it fairly concisely and accurately. If you have a better way to explain it, please post a comment below.

Notice that the description doesn’t say anything about pedigree or regulatory compliance. EPCIS is a standard, but it’s a general purpose IT thing that you have to apply a specific way in order to make it work as a pedigree system. The standard is designed to be very flexible and for serialized product, it could be quite powerful if used right. There are a couple of problems for those who want to use it as a pedigree system, however.

• There is currently no standard that describes exactly how to apply it as a drug pedigree system that would ensure interoperability across the supply chain;
• There is the general tendency to talk about ways to turn EPCIS into a pedigree system, but I haven’t heard one yet that is likely to comply with existing pedigree laws.

I’ll cover those issues in more detail in later posts.

DPMS (Drug Pedigree Messaging Standard) is a GS1 standard that was specifically created to assist the pharmaceutical supply chain with creating an interoperable system to trace drugs in a way that can comply with existing pedigree laws. That includes Florida, California, the PDMA and all of the other states that currently have pedigree laws. The problem is, it doesn’t do much to assist companies with all of the many problems they face dealing with serial numbers on items. DPMS can take serial numbers and use them to trace those items, but there are a lot of other, non-compliance issues that must be dealt with first.

So there are problems with both standards. Perhaps an obvious solution is one that I, and others, proposed last year to combine EPCIS and DPMS to create a system that benefits from the best of both standards.

As you might imagine, there is a lot more I could discuss on this topic in later posts. But I’m going to try to stay out of the details and talk more about implications of each approach. Stay tuned…