How have you been?  I’ve been fine, done a bit of writing since we last met and gotten a little greyer.  How are the kids?  My two kids are doing great but I have to admit, after raising two I don’t know how you do it with 125 kids, or whatever the number of M.O.s there are today.

The reason I’m writing to you today is to offer you my thoughts on your Global Data Synchronization Network (GDSN) Marketing campaign.  That campaign would be more effective if it focused on demonstrating the distinction between internal master data (and programs associated with improving its quality), and externally shared master data (and the significantly different kinds of programs needed to improve its quality).  And especially to show that many (most?) of company master data is, in reality, externally shared master data, either incoming or outgoing.  That’s the step that I see missing from your campaign.

Companies who are already familiar with the kind of programs that are designed to improve their internal master data need to be taught to see the special characteristics of the externally shared master data which they could publish for the benefit of their trading partners, or which they could consume from the trading partner who “owns” that data.  These are the characteristics that make the externally shared master data unique from the purely internal master data.  This is the epiphany that your marketing campaign should seek to impart.

Your campaign should acknowledge the existence of internal master data—the kind that benefits from the traditional data quality management programs but which would not benefit from the use of GDSN.  By separating this kind of data from the externally shared kind of master data you will help companies recognize on their own why they may have had so much difficulty elevating and sustaining the quality of this class of data in past data quality efforts.  Once that realization occurs, the need for, and the value of GDSN will become obvious and you will no longer need to “sell” anyone on it.  They would seek it out instead.

HERE’S HOW YOU DO IT

It’s really pretty simple.  All you need to do is to define a new term for the externally shared master data, a term that makes it clear that it is distinctly different from internal master data.  I have proposed the term “Supply Chain Master Data” (SCMD) in the past (here, here, here and here) because I believe it accomplishes that goal.  SCMD is MD that is shared within a supply chain.  I offer that term to you (it isn’t protected as far as I know)—or make up your own.  As long as you talk about SCMD as a special class of MD and how it’s quality can benefit from the application of GDSN I think you will get a lot more agreement because it will finally make sense to people, especially those who are new to GS1.

Whether you pick up my suggestion or not I wish you luck in your current marketing campaign.  I look forward to see you at our next meeting.  Say hi to the spouse and kids.

Sincerely, Your Friend,

Dirk.

As I knew him, Jim was a very open and expressive person who was always ready for a good laugh.  He was razor-sharp, quick witted and not afraid to get to the point of the matter.  To me, he was fearless and a fun guy to be around.  I remember listening in on the webcast of the FDA Track and Trace Workshop last year when Jim’s unmistakable voice came through my speakers during one of the input periods.  “When would you like that by?”, he asked rhetorically.  The room erupted.  Jim had already made the point that many in the room were still trying to formulate in their minds.  Classic.

I will miss Jim.  He left this earth way too early.

Dirk.

Congratulations are due to the law enforcement organizations who contributed to the investigation and to bringing the charges.  They include DEA, ATF, FBI, U.S. Attorney of Florida, Miami-Dade Police Department, Florida Highway Patrol, U.S. Attorney of Illinois and U.S. Attorney of New Jersey.

This episode highlights one of the things I call the built-in protections of the U.S. pharmaceutical supply chain—the things that, combined, result in the U.S. having the safest supply chain in the world.  In this case, it is strong and cooperative law enforcement organizations.  While far from perfect, would you trade our system of justice, including law enforcement, with that of any other country in the world?  I don’t think you would (unless you’re one of the Villa brothers or their associates!).

But what are the other components that result in the safest drug supply chain in the world?  It’s certainly doesn’t occur by accident, so what are the built-in protections?

MY LIST OF THE BUILT-IN PROTECTIONS

As far as I can tell, no one has done a formal study to isolate the complete list of reasons why the drug supply chain here is the safest in the world.  My list is certainly not a formal study but it includes the things that I could think of.  Make sure you submit a comment below to add anything I’ve missed.  I’m sure there are several.

• Licenses
  You can’t become a member of the legitimate pharmaceutical supply chain—whether manufacturer, repackager, distributor, 3PL, pharmacist, pharmacy, doctor, nurse or hospital without obtaining at least one, and often multiple licenses.  To obtain and retain the necessary licenses applicants need to periodically demonstrate that they are qualified to fill the role they are applying for.  Most of these licenses require substantial investments in time and/or money to initiate and maintain.
  
  
• Penalties
  The U.S. Federal and State governments have established certain penalties for crimes in the pharmaceutical supply chain.  I think most people would agree that they are currently too low considering how damaging these crimes can be to innocent people (see my essay “STEP #1: Raise Penalties For Drug Crimes To Reflect The Widespread Harm They Can Inflict”), but at least we have penalties that can be applied when criminals are caught.
  
  
• Strong and cooperative law enforcement organizations
  As the episode last week highlights, this is an indispensable ingredient!
  
  
• A “closed” distribution network
  The requirement that all supply chain parties obtain licenses, combined with the fact that drugs cannot be reimported (see my essay, “Safe Prescription Drug Reimportation: An Oxymoron”), results in a “closed” supply chain.  Not just anyone can leap into the legitimate supply chain and start buying and selling drugs.  If you’re going to get into this business, you need to have some resources behind you that make it clear that you are legitimate and you place the interest of patients high in your list of priorities.  A vital part of this component is for trading partners to verify that those they are buying from and selling to possess valid and current licenses.  This is one of the weakest links in the U.S. supply chain as demonstrated by crimes that have occurred in the last five years (see my essays “How Counterfeit Avastin Penetrated the U.S. Supply Chain”, “Lessons from ‘Drug Theft Goes Big’” and “STEP #1: Raise Penalties For Drug Crimes To Reflect The Widespread Harm They Can Inflict”).
  
  
• Commitment by large distributors to only buy direct from the manufacturer
  About six years ago the largest U.S. distributors, representing about 75% of the drugs distributed in the U.S. legitimate supply chain, publicly committed to only buy their stocks directly from the drug manufacturers (see my essay “Do We Even Need To Mandate Drug Pedigrees Anymore?”).  This was a big and important change because prior to that they all had business units whose purpose was to buy some of their stocks from the secondary market—overstock drugs sold by non-manufacturers.  This practice was found to open the door to criminals selling illegitimate drugs—including counterfeit, diverted, up-labeled, improperly stored, tampered, etc.—back into the legitimate supply chain.  Many of the crimes documented by Katherine Eban in her book “Dangerous Doses…” may have been made easier as an unintended result of this type of buying practice.  By making that pledge, this door was closed, at least for that 75% of drugs that come through these organizations.  However, this is a voluntary pledge that not all drug distributors in the U.S. are even able to make.  Again, Katherine Eban documented a case that showed this is an ongoing weakness in the U.S. supply chain (see Eban’s engaging and eye-opening article at CNN/Money online, “Drug Theft Goes Big”).
  
  
• The general low tolerance for crime and corruption by the American public
  Americans have what I call a general low tolerance for crime and corruption compared with many places in the world.  We generally expect our government and system of commerce to be free of the kinds of activities that often lead to illegitimacy.  This may turn out to be one of the most difficult components of a safe drug supply chain for countries in the world to emulate.  You can adopt all of the other components I have listed above, but if the public accepts crime and corruption as the norm, you are going to have crime and corruption, and your drug supply is not going to be safe as a result.  Fortunately the U.S. isn’t the only country in the world whose public has a low tolerance for these things.  I would bet that the public tolerance for general crime and corruption is closely correlated to the safety of a given country’s drug supply.  It would be an interesting thing to study.

CAN WE DO EVEN BETTER?

Even with all of the things listed above going for us, criminals still attack our drug supply.  But that’s going to happen any time you have something as lucrative as our drug supply has become no matter what protections you impose.  Criminals are always going to be attracted by the high value of drugs in the U.S. market.  You can’t prevent criminals from making attempts, but in an ideal world, the built-in protections would always block them.

In my opinion, we have a system today that is remarkably resistant to those criminals.  Last week’s arrests demonstrated that resistance.  As long as criminals can always be detected, caught, charged, prosecuted and their work is prevented from harming patients—as it appears will occur in this case—the built-in protections are a smashing success.  What more needs to be done?

But not all crimes have been prevented by our current built-in protections.  Is there anything more we can do to reduce the criminal success rate even farther?  Do we need to augment our existing built-in protections with new ones?  If so, which new protections should be built-in?

I think it is possible to do so but considering the low success rate of drug supply chain crimes in the U.S. supply chain today (see my essay “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack”), we may be within the realm of diminishing returns.  Further improvements will require careful study to determine the weaknesses that criminals are able to take advantage of today to ensure that any new protection we add actually has a positive impact on those specific vulnerabilities and does so with the least cost.

So far the closest thing I’ve seen to that kind of study was published by the FDA last fall with the publication of “FDA Preliminary Report: Review of Counterfeit and Diversion Criminal Case Information”.  It is a start, but it is too superficial, is not representative of today (the study only looked at FDA Office of Criminal Investigation (OCI) cases investigated between 2003-2008) and does not look at possible additional protections.  The report concludes:

“…the results [of the review] may not be representative of current drug supply chain trends.  This review is intended to provide some insight into the schemes, types of products, and supply chain participants involved.  We recognize that to conduct a more in-depth analysis and to achieve a full understanding of the supply chain complexities and the possible sources of sampling bias, additional data sources, such as those from industry, would be necessary.  This report provides results from an initial review of the OCI case information and does not contain statistical inferences, future trend predictions or opinions.  FDA expects to conduct further analysis and report as appropriate.”

WHAT ABOUT DRUG PEDIGREES?

I chose not to include existing pedigree regulations—like the Federal Prescription Drug Marketing Act (PDMA) and the Florida drug pedigree law—in my list because I don’t think they have contributed to the protection of the supply chain.  I don’t think that will surprise anyone (leave a comment below if this opinion surprises you) because the regulations that came from the respective laws apply to so few drugs in the supply chain and they primarily only affect distributors.  These regulations add cost but no real protection.  This is the kind of reaction to crime we need to avoid in the future.

You might think my negative opinion of the PDMA and Florida law would also apply to the California drug pedigree law, but the differences between it and those less effective laws address many of their shortcomings (see my essay, “The California Pedigree Law” for a catalog of the differences).  The biggest problem with the California law is that it results in a “big bang” deployment of drug pedigrees in the California supply chain.  A big bang won’t work because the leap in technology used in the supply chain is too great for such a short time span (2 ½ years).  The approach I advocated in my essay, “Plateaus of Pharma Supply Chain Security”, and then clarified in the essay, “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach” (see how complex this work is, it needed a follow-up clarification!), was an attempt to address that problem.

The folks from the Prescription Drug Security Alliance (PDSA) apparently agree that the problem is the “big bang” nature of the California law because their RxTEC proposal also appears to be an attempt to address that characteristic (see my essay, “What If RxTEC Isn’t Adopted?”).  In any attempt to address the “big bang” problem the first plateau/stepping stone is not going to offer much additional protection against criminal activity, and that’s true of both my recommended approach and of the RxTEC proposal.  The first steps are designed to deploy some of the necessary technologies throughout the supply chain and get companies familiar with them so that later plateaus/stepping stones can make use of those technologies smoothly to finally gain the protections sought.

The biggest problem with the RxTEC proposal is that it only describes the first plateau/stepping stone and so you can’t tell how or when the actual protection will occur in the implied later plateaus/stepping stones.  You can’t tell if those future protections will address the vulnerabilities of today’s supply chain because they aren’t identified.  On the other hand, in my RxTrace essays I advocated a step-wise approach where experts would fill in the blanks of each step/plateau/stepping stone.  The specifics I included in the essays for each plateau were intended to be examples of what might be done, not necessarily specific proposals.

A FORMULA FOR IMPROVING SUPPLY CHAIN PROTECTION

Everyone seems to leap to the solution without studying the problem first.  In my view the formula for improving the protection of the U.S. drug supply chain is logical.  What it needed is to first find some way to get the industry and regulators to rally around the step-wise approach in general—no specifics yet.  That shouldn’t be hard to do…the members of the PDSA are apparently already there.  Then study recent crimes that were “successful” to identify the current vulnerabilities in the supply chain.  Then determine alternative approaches that would address those vulnerabilities as new built-in protections (including costs).  Next, select the lowest cost approach that addresses the identified vulnerabilities and finally figure out the steps and timeframes needed to make the necessary technology widespread.  That may take some time to accomplish but any other approach is like shooting in the dark.  No one is going to be satisfied with the results.

In this essay I’ve certainly left something for everyone to comment on.  Submit one below.

Dirk.

All WMS systems that I am aware of are intended to be sold into multiple industries, not just in pharma.  That’s so that the WMS vendor can maximize their sales.  The more industries, the more sales and the more profitable it is.  Because some industries have long had serial numbers on some of their products (computers and peripheral equipment, cell phones, electronics, medical equipment, appliances, etc.) WMS vendors have included serial number handling in their software for decades.  In fact, I would bet that a serial number handling feature was included in WMS systems since the very beginning of that category of software.

However, buyers of WMS systems in the pharma supply chain should be very careful not to confuse a “serial number handling” or even “serialization” checkbox on the WMS vendor’s spec sheets with the kind of “serialization” they will need for compliance with modern pharma serialization regulations.  I include the California Pedigree Law, the potential future serialization requirements that may (or may not) be coming from the FDA, and those in the E.U.

THE DIFFERENCE BETWEEN WMS SERIAL NUMBER HANDLING AND PHARMA SERIALIZATION FOR REGULATORY COMPLIANCE

The reason is simple.  Despite the similar (or same) name, serialization in the pharma supply chain leads to significantly different functionality than dealing with serial numbers on products in other supply chains.  For example, think about what would be needed for a personal computer manufacturer.  They would need to keep track of which serial number is applied to which models.  They may want to keep track of who they shipped which serial number to, and they may want to connect their warranty registration, returns, warranty claims and service processes to their serial number database so they can make sure they know exactly which sub-model revision (hardware, firmware and software) they are dealing with and to confirm that the customer is valid (for after-sales service).  All of these serial number tasks can be easily accomplished within the WMS, within an add-on module, or within some module of the ERP system because they normally do not need to communicate with the systems of other companies.  These same kind of capabilities would be needed for all of the types of products I listed above.

But these capabilities are distinctly different from those that members of the pharma supply chain are going to need going forward and so these traditional serial number features of WMS systems are insufficient.  The pharma supply chain needs to use the serial numbers on drug packages to authenticate the supply chain history, either at each stop (California), at the point of dispense (E.U.), or somewhere in between (potential future U.S. FDA regulation).  This requires a different approach.

First, all companies within a given supply chain must follow certain standards to ensure interoperability of the serial numbers themselves and the how they will be handled across all members.  That is, a WMS vendor can’t simply make up their own serial number handling features because they will not interoperate with those from other vendors.  Second, some kind of standardized data exchange related to the serial numbers must occur between trading partners, and third, the management of the data must also be standardized so that the same functionality is made available to all parties in the supply chain.

STANDARDS ENABLE INTEROPERABILITY ACROSS THE SUPPLY CHAIN

In the U.S. and in many other countries around the world, GS1’s Global Trade Item Number (GTIN) plus serial number (or SGTIN) is the standardized serial number that has been chosen (see my essays “FDA Aligns with GS1 SGTIN For SNDC” and “California Enforcement Subcommittee Moves To Require FDA SNI” and also see the GS1 General Specifications).

In California the GS1 Drug Pedigree Messaging Standard (DPMS) is known to be usable for compliance and would fulfill the necessary standard format for data exchange and data management.  However, the industry has more recently been interested in the use of GS1’s Electronic Product Code Information Services (EPCIS) standard as the basis for the standardized data exchange and data management.  Personally I don’t think anyone has shown satisfactorily that it will comply with the current California law but it appears that companies who are members of GS1 U.S. Healthcare Traceability group are hoping that it will.  (See my essays “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1” and “…Part 2”.)  If the California Board of Pharmacy is willing to accept it, then it can be used for compliance, but until we know that, I think it’s risky to deploy systems that are only based on EPCIS.

We won’t know which standard will fulfill the needs of whatever federal pedigree regulation, if any, may be on the horizon until the regulation is published by the FDA down the road.  So far it is probably a good bet that EPCIS will play an important role and it is very unlikely that DPMS will play any role.  We’ll see…

Ignoring the debate over which GS1 standard would be used in the U.S., the point is, the existing serial number handling features of today’s WMSs will not be sufficient because they are intended for something else.  The key characteristic that both DPMS and EPCIS have that is missing from those existing WMS features is that they are able to document supply chain events that occur to GS1 serial numbers and therefore to the products associated with those serial numbers.  This includes Commissioning, Aggregation, Shipping and Receiving, among others.  When you include the fact that they are both standards that all solution developers can follow, which results in interoperability between their solutions, DPMS and EPCIS are the only ways to address the needs of these modern requirements in the pharma supply chain.

WMS AND SERIALIZED EVENT REPOSITORIES

I once thought that WMS and Pharmacy Management System (PMS) vendors would see the difference and perhaps would add at least the standard EPCIS interfaces to their products (see my essay “The Future of Traceability Repositories and Inventory Management Systems”), but as far as I know that hasn’t happened.  Perhaps they have concluded that a WMS isn’t really the place to store supply chain events.

The whole point of a WMS is for managing inventory and warehouse processes.  Serialized supply chain events are related to things that pass through the inventories, but the life of those events could extend well beyond the life of the typical data element a WMS needs to deal with today.  The data communications and management needs of serialized supply chain events is also beyond the traditional scope of a WMS.  It now seems to make more sense to have a separate repository just for those events and maintain minimal connection between that repository and the WMS.  Perhaps the only connection would be related to the time that the serialized products are present in the inventory that the WMS is managing.

Figure 1.

That might require some interface(s) between the two systems since the serialized event repository is an inventory system of a sort.  For each product code the WMS will likely maintain an inventory count and the event repository will likely maintain a list of serial numbers in the same inventory.

If you are shopping for a new WMS and you know you will need to comply with a pharma serialization regulation, make sure you fully understand the limits of the serial number handling capability of the products from each vendor you are considering.  Don’t assume that you will be covered just because the spec sheet has a check box for “serialization”.

Dirk.

That’s because currently, drugs sold into the U.S. market must contain a linear barcode that encodes your U.S. Food and Drug Administration (FDA) National Drug Code (NDC).  To properly encode that NDC into a GS1 barcode symbol, you must register with GS1 US the GS1 GCP that matches the FDA-assigned Labeler Code that is a part of every NDC.  Only GS1 US can assign/register a GCP that matches your FDA-assigned Labeler Code.  I explain all of this in more detail in my essay “Anatomy Of The National Drug Code”.

Companies may end up with more than one GCP over time for several reasons.  For example, if a drug company is based in Switzerland, merged with another pharmaceutical company in France a few years ago and sells pharmaceuticals globally, they may end up with the following GCPs:

• One issued by the Swiss GS1 M.O. obtained originally by the parent company
• One issued by the France GS1 M.O. obtained through the merger
• One issued by the U.S. GS1 M.O. registered by the parent company for use in identifying drugs sold into the U.S. market
• One issued by the U.S. GS1 M.O. obtained through the merger for use in identifying drugs made by the subsidiary in France and sold into the U.S. market

All of these GCPs have value for the parent company and to maximize that value, the parent company should view these GCPs as enterprise resources and manage them that way.  Number allocation based on these GCPs should be managed centrally using a strategy that is designed to maximize the benefit to the whole organization rather than to silos within the company.

WHAT IS A GCP USED FOR?

A GS1 Company Prefix is at the core of “The GS1 System”, a set of standards used globally for identification of products, services, assets, relationships and even documents.  These entities are identified in the GS1 System at the class level or at the serialized unit level through numeric “keys”.  All GS1 keys use the GCP as their foundation so that each key is uniquely specific to the owner of the GCP on a global basis.  Once a company is given the right to use a GCP they are free to define any key using that GCP without fear that they will clash with anyone else’s key, and without additional cost.  The remainder of each key is used to hold additional information to identify the target entity.  Refer to the GS1 General Specifications for full details (check with your GS1 M.O. or just search for a downloadable copy on the internet).

The GCP can vary between six and ten digits in length in the U.S. and may have a different variation depending on the M.O. making the assignment.  The following diagram is just a generalized depiction of that.

Here is a list of GS1 keys that are based on the GCP:

• GTIN (Global Trade Item Number) in 8, 12, 13 and 14 digit flavors, and the serial numbers associated with them when forming an SGTIN;
• GLN (Global Location Number) 13 digits;
• SSCC (Serial Shipping Container Code) 18 digits;
• GRAI (Global Returnable Asset Identifier) 14 digits, first digit is always a zero plus optional serial number up to 16 additional characters;
• GIAI (Global Individual Asset Identifier) up to 30 characters;
• GSRN (Global Service Relation Number) 18 digits;
• GDTI (Global Document Type Identifier) 13 digits plus optional serial number up to 17 additional digits;
• GINC (Global Identification Number for Consignment) up to 30 characters;
• GSIN (Global Shipment Identification Number) 17 digits.

Each type of GS1 key includes a numeric value that is combined with the GCP to form a specific instance of the key.  It is the assignment of these numeric values that must be managed in some way.  The total length of the key minus the length of the GCP determines how many digits are available to the owner to assign specific instances of the key.  These digits represent the “key space” for a given key.  The shorter the GCP, the larger the key spaces of each key type will be.

(NOTE:  As George Wright rightly points out in his comment below my off-hand formula for calculating the available digits in the key space leaves out the check digit in some keys as well as certain other individual digits in other keys.  Please refer to the GS1 General Specifications for the full calculation for each individual key type.)

CENTRAL MANAGEMENT OF GCPs AND GS1 KEYS

Companies of any size will benefit by managing all of their GCPs and GS1 keys in a single location and perhaps through a single database and application.  It enables the enforcement of a single corporate strategy for number assignment within each key space and ensures that duplicate values will not be generated and number ranges will not be wasted.

It is not necessary for the central GCP management authority to assign every single value for all of the keys to maintain control.  This is particularly true for high frequency assignment keys.  For example, the responsibility for assigning specific SSCC values may be delegated to remote systems.  Even then, the remote systems should be designed to acquire number ranges from the central system so that the enterprise strategy is maintained.  Once a number range is acquired by the remote system it can perform its own assignment of the SSCCs within the allocated range as necessary.  When it gets close to exhausting the current range of values it can request the next range from the central authority.  For small companies this could be done manually, but for mid to large companies, this should be automated.

Keys that are assigned at low frequencies, like GLN—which would only need a new assignment when a new location is established—or GTIN—which would only need a new assignment when a new product or new variation is introduced—could be done manually even in larger companies.  Whether manual or automated, central management of lower frequency keys is even more important than the high frequency keys in my view, to ensure that used numbers are properly kept track of.

Central management of all GCPs owned by a company allows the central authority to minimize the need to acquire new GCPs by maximizing those that are already under their control.  A central authority can ensure that the key spaces of each key are fully utilized before either reusing previous values (do so very carefully) or acquiring a new GCP.  In most cases these decisions should not be left up to remote business units or you might find that the enterprise possesses many more GCPs than are actually necessary.

Central management of serial numbers associated with GTINs–to form GTIN plus serial number, or SGTINs–should also be controlled centrally whether done individually or through number ranges.  This allows the enterprise to make use of a single serial number assignment strategy, including some form of randomization, if desired, like the kind offered by RxTrace advertiser Kezzler.

The introduction of a new GCP through a central authority can be much cleaner and much more efficient than if done otherwise.  Remote systems should not make any assumptions about the GCPs within the GS1 keys they are provided, whether individually or within ranges.  That way the central GCP authority can introduce the use of new GCPs at any time necessary.

Very large enterprises that make heavy use of GS1 keys might have a group that is dedicated to managing their GCPs and GS1 keys, but most companies will be able to make it fit within a group that is responsible for other data-related activities.  Good candidates for the GCP management responsibility within an enterprise are the Master Data Management (MDM) group or some other existing data management group.

Regardless what group the responsibility ultimately falls, central management of your GCPs and associated GS1 keys is a good idea.  If your company does not currently have central management, I suggest you start asking questions to find out:

• How many GCPs does your company control?
• Who manages the key spaces of each one?
• Does anyone know exactly which key values have been consumed within each key space of each GCP?
• Who has the authority to acquire a new GCP and for what reasons?

You might be surprised at what you find.

Dirk.

The FDA fulfilled these instructions for one of the specific standards that the law identified when the agency published their Standardized Numerical Identifier (SNI) standard back in 2010.  That standard was fairly high level and for the vast majority of drugs, use of GS1’s Serialized Global Trade Item Number (SGTIN) (or “GTIN plus serial number”) for drug package identification would comply with it.  The text of the FDA’s standard says as much.

By defining the SNI in this way did the FDA surrender the development of the real SNI standard to GS1 (at least the sNDC portion of it)?  I don’t think so.  In my essay about the SNI standard I described it as the FDA “aligning” with GS1’s SGTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”).  Alignment shouldn’t be confused with surrender.  The choice of alignment with SGTIN was good for the FDA, good for patients and good for the industry.

WHAT WE GOT WHEN THE FDA ALIGNED THEIR SNI STANDARD WITH GS1’S SGTIN TECHNICAL STANDARD

In the case of the SNI aligning with GS1’s SGTIN we got the following things:

• An existing robust global standard that has multiple years of use by multiple industries—including the pharma supply chain—and in multiple countries;
• Automatic interoperability with the regulatory requirements of other countries who have, or will, align with the SGTIN;
• Automatic interoperability with all of GS1’s other—current and future—standards that use the SGTIN as a key component (see my essay “GS1 Standards – Betcha Can’t Use Just One!”);
• Automatic interoperability with lots of existing third-party applications that are already designed to work with the SGTIN.  Some companies in the supply chain had already deployed these systems and now they can proceed with further deployments knowing that by doing so they will remain compliant with the FDA SNI standard;
• Widespread existing knowledge and understanding of the SGTIN and how to apply it within the industry.

These are huge benefits.

In contrast, China’s State Food and Drug Administration (SFDA) chose to expand the use of their own existing product serialization standard to include drugs, but that standard does not align with the GS1 SGTIN.  That will probably benefit the government there and perhaps domestic companies who are serving only the China market, but it could also complicate international trade in pharmaceuticals where companies from China are a party.

SO SHOULD FDA CEDE ALL STANDARDS DEVELOPMENT TO GS1?

The fact that FDA’s choice to align with GS1’s SGTIN provided so many benefits should not be taken as a sign that the FDA should simply mandate other GS1 standards to fulfill their obligation under FDAAA of 2007.  It made sense when it came to the foundational SNI to use the foundational SGTIN as the aligned standard, but that’s about as far as you can go.  GS1 doesn’t have standards that are out-of-the-box usable for “…validation, authentication, and tracking and tracing of prescription drugs”.  Those are high-level applications, not foundational standards like SNI.

Yes, you can use some of GS1’s standards as the basis for applications that might validate, authenticate and track & trace prescription drugs—likely including GS1’s Electronic Product Code Information Services (EPCIS) and related standards—but it is much harder for the FDA to “align” with those standards without a lot more FDA-specific explanation of exactly how they might be applied to implement those applications.  That FDA-specific explanation would be the description of an authentication and track & trace “model”, which might use GS1 standards under the covers.

The best thing GS1 has done that the FDA might be able to use to help them formulate their authentication and track & trace “standards” is the output of the GS1 Healthcare Network Centric ePedigree (NCeP) work group.  That group simply documented the characteristics of eight different ePedigree models that would be based on GS1 EPCIS.  The documentation amounts to a concise “catalog” of authentication and track & trace models that the FDA could use to help them select a viable model for their “standard”.  (They should also see my RxTrace essays, “The Viability of Global Track & Trace Models”, “Plateaus of Pharma Supply Chain Security”, “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach” and a bunch of others in my back catalog.)

Regardless of what FDA chooses to do in the development of the standards mandated by Congress, they should not and certainly will not cede it all to GS1.  The mission of the FDA is completely different from the mission of GS1 and the standards they each publish reflect that difference.  While I wouldn’t be surprised if the FDA authentication and track & trace standards include some references to GS1 technical standards, they will need to provide a lot more additional details than they did in the SNI standard.

We shouldn’t have long to wait to get an initial glimpse of where the FDA is going with their track & trace standard.  As I reported in my essay “InBrief: FDA To Publish Track & Trace Standard By Year End”, we should see the first draft by the end of the year.

Dirk.

• Fully Centralized,
• Semi-Centralized, and
• Fully Distributed.

I’ve discussed some of the pros and cons of these models here in RxTrace too (see “The Viability of Global Track & Trace Models”, “Should Regulations Dictate Technology?”, and “Could This Be Your Future Track & Trace/ePedigree Exchange Solution?”).

One of the characteristics included in many of these discussions is the “points of failure” of each model.  For example, I’ve heard it said several times that the Fully Centralized model suffers from a “single point of failure”, with the implication being that Fully Distributed models do not have this problem.  In fact, this is incorrect and in reality, both the Fully and Semi-Centralized models are much less likely to fail than models that fall within the Fully Distributed category when “failure” is defined as not being able to provide an ePedigree on demand in any given instance.

RELIABILITY ENGINEERING OF COMPLEX SYSTEMS

Wikipedia has a pretty good article on Reliability Engineering so I’ll spare you the background of the discipline that studies points of failure.  The mistake people sometimes make when comparing the centralized and distributed ePedigree model classes is to think that a single central repository is like “putting all your eggs in one basket”, and the distributed models is like “spreading your eggs out”, but this is wrong.  When it comes to the ability to produce an ePedigree on demand in a given instance, a model where all of the data is held in a single location is going to come out better in the failure analysis than one where the data is fragmented and spread out among multiple distributed databases and needs to be collected to produce a complete ePedigree.

In fact, all things being equal in each repository, the likelihood of failure would be at least n times greater, where n is the number of distributed repositories holding the fragmented ePedigree data.  That’s because, all things being equal in each repository, if any one of the distributed repositories experiences a failure, the overall system fails because it is incapable of producing the ePedigree.

BUT ALL THINGS WON’T BE EQUAL

In a Fully Centralized or Semi-Centralized ePedigree model the central repositories would be designed and maintained under contracts issued by multiple parties who would share an interest in high availability (HA) and disaster recovery (DR) so you can bet that there would be multiple online copies of the data hidden behind the façade of a single point of access.  More than likely those multiple copies would include copies that are widely separated geographically to mitigate the risks of major weather events (hurricanes, tornadoes, ice storms, etc.), natural disasters (tsunamis, fires, earthquakes, floods, etc.) and man-made disasters (terrorist attacks, war, etc.).  Even Twitter applies these principles to ensure that we won’t have to miss out on the latest celebrity drivel during and after one of these disasters.

The investment in the centralized repositories would be spread across multiple parties so more could be spent on ensuring that the data is protected without causing any one participant to pay excessively.  The costs would be spread out.

But in a Fully Distributed ePedigree model each data contributor—each supply chain participant—would be independently responsible for designing and maintaining their own repository to hold their fragment of the ePedigrees for the drugs they make, buy, sell and/or dispense.  Even many of the larger corporations in the supply chain may not have the expertise in-house—or the willingness—to apply the principles of HA and DR when designing their repositories.  It is extremely unlikely that all members would be able to do what is necessary to minimize the odds that some disaster would prevent them from providing their fragment of the ePedigrees requested.

For this reason we can’t use the phrase “all things being equal” between the repositories in the two centralized models and the distributed models.  Things are not going to be equal, and so the odds of a failure in the distributed models would be much worse than even n times greater than those of the centralized models.

WOULD A CRIMINAL CONTRIBUTE THEIR PEDIGREE FRAGMENT?

Now let’s throw into our scenario what happens when one of the supply chain participants is actually a criminal in disguise (for an example of how that can occur, see my essay “Lessons from ‘Drug Theft Goes Big’”).  In either of the two centralized models they would need to supply their ePedigree fragment data to the centralized repository before they could sell a given drug package.  The central repository would need to validate the data they contributed and if it doesn’t check out, the criminal activity would be exposed immediately and the illegitimate drug would not be able to move further down the supply chain.

But in a distributed approach the criminal wouldn’t need to supply their ePedigree fragments until later, perhaps only when someone becomes suspicious and requests the full ePedigree for a particular package of drugs.  When the criminal receives a request to supply their ePedigree fragment for a package that they know has an illegitimate history do you think they would supply that data?  Certainly not!  They would claim that they are having “system problems” and if pressed, the data would get “lost” somehow.  They are criminals, after all, and that data would be self-incriminating!

I hope you can see that a centralized ePedigree model is actually much less susceptible to failure—whether unintentional or intentional—than a distributed model.  I’ve grown to really appreciate the centralized models—particularly the semi-centralized model for free-enterprise countries.  I don’t see any characteristic where a distributed model outperforms the supply chain protections of a centralized model.  Do you?  Leave a comment below and set me straight!

Dirk.

So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”).  Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN:

• GS1 UPC barcode symbology
• GS1 element strings encoded in a barcode symbology such as:
• GS1-128
• GS1 DataMatrix
• GS1 DataBar
• GS1 EANCOM EDI standard
• GS1 EPC RFID in frequencies such as
• UHF
• HF
• GS1 Electronic Product Code Information Services (EPCIS)
• GS1 Drug Pedigree Messaging Standard (DPMS)
• GS1 Global Data Synchronization Network (GDSN)

GS1 Healthcare is a community organization of end users within GS1 who are members of the global healthcare industry.  That organization created the following figure to show how GLN and GTIN are foundational to patient safety and supply chain efficiency, the ultimate end goals of its members.  At the top of that foundation is GDSN and above it are the five pillars of patient safety, which support the ceiling of supply chain efficiency and the overall roof of patient safety.  (See “Change has finally come:  U.S. Healthcare industry to implement common data standards to improve safety, reduce costs” by Joe Pleasant, CIO and SVP, Premier, Inc.)

GS1 Healthcare Patient Safety "House of Standards"

Many U.S.-based hospital Group Purchasing Organizations announced a number of years ago that they would require the use of GLN and GTIN by December 2010 and 2012 respectively.  Apparently at least one of those GPO’s also requires the use of GDSN but without specifying a date.

GS1 GLOBAL DATA SYNCHRONIZATION NETWORK (GDSN)

GS1’s GDSN is a standard that can be used by supply chains to communicate product class-level supply chain master data (SCMD) to all of the companies who participate in it.  Here is how I described it in my essay, “Supply Chain Data Synchronization and Patient Safety”:

“Generally, [GDSN’s] use requires all trading partners in a given supply chain to subscribe to a GDSN-conformant Data Pool service provider.  Unilateral adoption of GDSN by a single company doesn’t make any sense.  It’s a high bar for a large and complex supply chain to achieve through voluntary means.  Right now the pharma supply chain in the U.S. has not achieved it and so the quality of SCMD in the supply chain is currently dependent on ad hoc relationships and data passing.  Some of this includes manual data entry into the local master data systems at many points in the supply chain.”

Here is one way GS1 draws GDSN.  This view emphasizes the plumbing and shows the “how” of GDSN.  (See “Global Data Synchronization Network® (GDSN) Operating Roadmap for GS1, Version 7.3” November 2011.)

Click image to enlarge

Here is my rendition of GDSN use in healthcare.  I show it as a cloud-based repository where the manufacturer publishes their product master data and where downstream trading partners can subscribe to it.  That way everyone in the supply chain—right down to the healthcare professionals at the points of care—are using the exact master data as published by the manufacturer.  Admittedly this rendition doesn’t show how GDSN is implemented, but I happen to think that’s less important that showing what it is.  See GS1 for the details.

Click image to enlarge

Up to this point in time there still hasn’t been any significant use of GDSN in the U.S. medical supplies and devices supply chain and it is tough to get an entire industry to adopt something so large without some kind of incentive.  The GPO’s are trying to provide that incentive by mandating its use, so at some time after the GTIN is widely adopted on medical supplies and devices, SCMD may be synchronized between manufacturers and hospitals, and perhaps distributors as well.

USE OF GDSN IN THE U.S. PHARMACEUTICAL SUPPLY CHAIN

GDSN is also not currently used in the U.S. pharmaceutical supply chain, but in my view, it will be a necessity if/when GS1’s EPCIS standard is ever used for track and trace applications like ePedigree.  In my view, EPCIS alone can’t be used for compliance with the existing pedigree regulations in the U.S. (see my essays, “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1” and “…Part 2”).

But EPCIS just might become the basis for the track & trace standard that the FDA will publish by the end of this year (see me essay “InBrief: FDA To Publish Track & Trace Standard By Year End”).  Many people believe that standard will be based on EPCIS, similar to the way FDA aligned their sNDC standard with GS1’s GTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”).  Include me in that group.

But, by design, EPCIS events do not carry SCMD (see my essay, “Pedigree Models and Supply Chain Master Data”), so if EPCIS events form the basis of an ePedigree, it will be a absolute necessity that all parties who are consuming and updating those pedigrees use the identical product class-level master data.  That would be necessary because everyone would need to agree on exactly what constitutes the drug that is referenced by the GTINs in the EPCIS events.  Without that common agreement on exactly what the GTINs mean, how can there be a true pedigree?

Here is a drawing that shows how GDSN could be used in conjunction with a semi-centralized ePedigree system that is built on top of EPCIS events.

Click image to enlarge

Notice how each trading partner in the supply chain communicates with both the GDSN cloud and the Semi-Centralized ePedigree cloud.  In actual implementation these clouds might not be so distinct because the same vendors might offer both, but I show them separate here because they are serving distinctly different purposes.

The GDSN cloud is serving as the common source of product SCMD as published by the manufacturer—keyed off of the GTIN—and the Semi-Centralized ePedigree cloud, based on EPCIS, is serving as the common repository for all supply chain events that occur to the actual unit-level instances of those products—keyed off of the serialized GTIN, or SGTIN.  The clouds also communicate with each other because, to produce a usable ePedigree report the ePedigree engine would need to obtain the SCMD from the GDSN cloud.

As I said, I think something like this will be a necessity if EPCIS is used as the basis of an ePedigree system.  So far when people in the industry talk about using EPICS for ePedigree they almost always forget the SCMD.  The ePedigree solution I show in the figure above is a very efficient model since the SCMD does not travel along the same path as the instance data (the EPCIS events).  This is in stark contrast to DPMS which needs to carry that data along with each ePedigree document—a big negative for that standard that many have pointed out over the years.

All pedigree models have trade-offs.  One of the trade-offs of ePedigree models based on EPCIS is that GDSN will probably have to be adopted throughout the U.S. pharma supply chain over a fairly short period of time, but no doubt patients would benefit greatly from that.

BETCHA CAN’T USE JUST ONE

There you have it.  Not only would pharma trading partners need to adopt GLN and GTIN, in this scenario they would also need to adopt EPCIS and GDSN shortly afterward.  In the pharma supply chain you can’t use just one!

Can you see any alternatives to this scenario besides adding DPMS in some way?  Leave a comment below.

Dirk.

I first learned about the significance of the annual document about 18 months ago when an FDA official explained it in a conference presentation.  In response to a question from the audience about when she thought the FDA would publish the Track & Trace (T&T) standard for pharmaceuticals, she recommended that people watch for a notice of it in the “Guidance Agenda…” each year.  She said that the annual guidance list was usually pretty accurate.  If the T&T guidance wasn’t listed, according to the FDA official, people would know that the standard wasn’t going to be published that year.  It wasn’t included in last year’s list, but it is in this year’s edition, which apparently means that we will see the standard by the end of 2012.

Congress instructed the FDA to create standards for Track & Trace, Authentication and Validation of pharmaceuticals in section 505D of the FDA Amendments Act (FDAAA) of 2007.  That’s the same section that instructed them to create the Standardized Numeric Identifier (SNI) guidance that was published two years ago.  In that case the only difference was, Congress gave them a specific deadline for the publication of the SNI standard but no specific date for the T&T standard.  But now we know it’s coming soon.

The FDA originally published draft guidance for the SNI and then, after collecting public comments on the draft, they modified it and published it as final guidance.  In my opinion, that process worked well for the SNI considering how well the final standard turned out.  I assume they will follow the same process for the T&T standard.

Like the SNI guidance, this new T&T standard will probably be non-binding, but remember, one of my theories is that this Federal T&T standard just could be the standard that ends up being adopted by States in place of their soon-to-be non-standard pedigree laws (see my essay “What Happens If RxTEC Isn’t Adopted?”).  If that happens, it could eliminate the existing patchwork of pedigree laws over time (maybe a long time) without the Federal government adopting any binding national pedigree regulation.

It’s hard to say, but it appears that sooner rather than later we will have a new Federal Track & Trace standard to consider.

Dirk.

Bottle ID photo courtesy of Optel Vision

One of the biggest challenges for companies in the U.S. pharmaceutical supply chain when the California pedigree law becomes operational after December 31, 2014 will be the need to maximize the efficiency of dealing with serial numbers on each drug package.  One way to do that is to maximize the use of “inference” where the case serial number is read and the unit package-level serial numbers are “inferred” from the unit-to-case aggregation information supplied by the upstream trading partner (See my essays “Inference in the Pharmaceutical Supply Chain” and “Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!”).

But the problem with the use of inference is that you need to be able to rely on the accuracy of the aggregation information that your supplier provides to you.  There is an element of trust in that—not just that you trust your supplier to be truthful with you but that you trust that your supplier’s case packing processes and systems will always accurately capture and document the unit-to-case hierarchy—or “aggregation”.  You must be able to trust that the aggregation information your supplier provides to you will be 100% accurate.  That’s a lot of trust.

If you trust that the aggregation information you were given by your supplier is 100% accurate, then you don’t need to take the time to explicitly read every unit package-level serial number on every unit packed inside each case.  Instead, all you need to do is read the one serial number on the outside of each case.  You would use that serial number to find the unit package serial numbers of all of the unit packages inside each case and then update the ePedigrees for those packages.  Remember, ePedigrees are not maintained at the case-level, they are maintained at the unit package-level.

Inference saves time and physical system operation—especially if the serial numbers attached to each unit package are encoded in 2D barcodes, which appears to be the direction most pharma manufacturers are going for serialization for California (see my essay “RFID is DEAD…at Unit-Level in Pharma”).

Without the use of inference, companies would have to open every single case of pharmaceuticals they receive or ship, pull the contents out, scan the serial numbers on each package to capture exactly what they are receiving or shipping and then pack them all back up again and reseal the case.  With the massive volume of drugs that pass through the large companies in the U.S. supply chain today, this would slow the movement of drugs and would cause distribution costs to skyrocket, not to mention opening the door to the introduction of new errors and theft (thus actually lowering the security of drugs in the supply chain).

The use of inference is critical to the successful operation of serialized drug ePedigree laws.

HOW INFERENCE WORKS

Manufacturers generally pack their serialized unit packages of drugs into shipping cases—themselves serialized—shortly after the packages are produced.  That way they can stock them in their own distribution centers before they are shipped to their customers.  When they ship cases of drugs to their customers they won’t want to open the cases either so even they would need to rely on their own unit-to-case aggregations to infer the unit serial number so they can create the unit-level ePedigrees at the time of shipment.

After drug distributors receive the cases from the manufacturer’s distribution center they open most cases and fulfill their customer orders by packing small quantities of unit packages in totes for delivery.  Once the manufacturer’s case is opened by the distributor and individual packages are removed the case-level aggregation information is no longer needed.  The distributor would typically read the unit-level serial numbers on each package as they are fulfilling customer orders and update the ePedigrees to reflect the shipment to the customer.

However, some customers order in quantities large enough for the distributor to simply deliver one or more entire cases of a drug.  In that instance, the distributor doesn’t need to open the manufacturer’s case and so they would rely on the manufacturer’s aggregation information to know exactly which unit package serial numbers are being shipped to their customer and so that they can update and pass the correct unit-level ePedigrees to their customer.  The distributor would pass on the manufacturer-supplied aggregation information to their customer for the cases that were shipped, along with the ePedigrees for the packages contained within them.

Since the distributor’s customer will also want to receive their shipment as efficiently as possible, they will likely make use of the aggregation information to update the ePedigrees that they received from the distributor so that they do not have to open every case and read the serial numbers on every package inside them.

Notice that in this scenario, the manufacturer distribution center, the distributor and the distributor’s customer are all relying on the accuracy of the aggregation information that was originally captured by the manufacturer at the time that the drug packages were packed into the cases.

BUT WHAT HAPPENS IF AGGREGATION INFORMATION IS NOT ACCURATE?

If the aggregation information is perfect every time, no problems ensue.  But what if the information is incorrectly crossed between two cases?  That is, the unit package-level serial numbers are attributed to the case serial number of a case that actually contains the serialized packages of another case, and vice versa.  And now assume that one (not both) of those cases is received by the distributor’s customer in the example above.

In that instance, once the customer eventually opens the case and reads the serial numbers on the packages they will find that they do not have any record of those serial numbers, and they will not have a valid ePedigree for those packages.  Without a valid ePedigree the drugs cannot be sold, returned or dispensed in California after the regulation goes into effect so these drugs cannot be used until the discrepancy is fixed.

And the same problem will occur at whatever company received the other case that was involved in the error.  Both companies will need to work backward through their supplier until someone reaches the manufacturer where the error may be solvable.  If the manufacturer agrees that a mistake has been made, they may be able to transmit the corrected ePedigrees to the distributor, who may then be able to update those updated ePedigrees to reflect their corrected shipment and pass it on to their customer who would then have to update the corrected ePedigree and thus finally allowing the customer to sell, return or dispense the drugs.

That’s a lot of very inefficient customer service interaction and in the mean time the drugs must sit on the shelf unusable.  I hope you can see that for inference to work, there is a lot of reliance being placed on the accuracy of the aggregation information generated by the manufacturer.

IS IT EVEN POSSIBLE TO GENERATE 100% ACCURATE AGGREGATION INFORMATION?

Yes, it is possible.  The way to always generate 100% accurate aggregation information is to use a special approach to the case packing operation.  The key is to read the unit-level serial numbers only after the packages are bound together in a serialized grouping (inner-pack or full case grouping).

This is easy to do when the drug packages are serialized with RFID.  Each drug package would have a unique RFID tag attached to it and the case packing operation can be done in any way that it is today—nothing special…no changes.

Then, after the cases are sealed and an RFID tag containing the case-level serial number is attached, the case would be run through an RFID reader where all of the unit-level serial numbers and the case-level serial number would be read and associated with each other to form the aggregation information for that case.  Since the cases are already sealed, there is no chance of a mix-up of the contents between two cases, or some other discrepancy.  If the RFID reader doesn’t pick up all of the expected serial numbers the case would be rejected for quality inspection and rework.

The reason this works is that RFID doesn’t require a “line-of-sight” to work.  That is, the RFID reader can read directly through the cardboard case material and pickup all of the tags in a short time.

But, remember, I pointed out above that few, if any, companies are likely to put their unit package-level serial numbers into RFID tags and instead the vast majority of drugs will be serialized using 2D barcodes.  Barcodes require “line-of-sight” to work.  So how do you read the unit-level serial numbers only after the packages are bound together (remember, that’s the key to 100% accurate aggregation information) when the labels that contain the 2D barcode are on the side of the bottles?  Once you bundle them together many of these labels will be covered and so the barcodes are no longer within a single “line-of-sight”.

A NEW IDEA SOLVES THE 100% ACCURACY WITH BARCODES DILEMMA

Bottle ID photo by Omega Design

I don’t know who first thought of this idea, but the solution is out there and in use by multiple pharma manufacturers.  It entails the use of a “temporary” 2D barcode that is inkjet printed onto the bottom of all empty bottles.  This barcode contains a unique “bottle identification number”, or, bottle ID, that is unique for all of the bottles within the current batch of the drug being bottled.  The purpose of this barcode is to keep track of the bottles within the packaging and case packing operation.  I call the barcode “temporary” because it is only used within the packaging operation.

After the bottle ID barcode is printed on the bottom of each bottle the bottles are filled with the drug, capped and then the serialized drug label is applied.  The drug label would have the unique serialized National Drug Code (sNDC) (and hopefully the drug lot and expiration date…see my essay “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach”) encoded in a 2D GS1 DataMatrix barcode image.

Bottle ID and sNDC Photo courtesy of Optel Vision (click to enlarge)

Immediately following the label applicator is the traditional vision system camera that verifies that the barcode, lot and expiration date is readable.  But in this new approach there would be a second camera that would simultaneously capture the bottom of the bottle to read the bottle ID barcode.  The line management system would associate the sNDC in the DataMatrix barcode with the bottle ID.  Since these two serial numbers are unique, the association is also unique.

Inner-pack bundle. Photo by Omega Design

Now the bottles can be bundled together into inner-packs that are wrapped in clear heat-shrink plastic film so that they are bound together in a single unit and an inner-pack serial number label applied to the top of the bundle.  The sNDCs are not all visible, but the bottle ID on the bottoms of the bottles are all still visible.  Because of the associations between the bottle IDs and the sNDCs, reading all of the bottle IDs in the bundle in a single image allows the line management system to know exactly which sNDCs are present in each bundle.  Now the sNDCs of the bottles bound together in the inner-pack bundle can be reliably and accurately aggregated to the inner-pack serial number.

Packaging Hierarchy. Drawing by Omega Design. Click to enlarge

Multiple inner-packs can then be assembled into a case using an automated case packing machine that has 2D barcode imagers strategically placed to capture the inner-pack barcodes as they are being loaded into a pre- or simultaneously-serialized case.  Now the case to inner-pack aggregation can be made accurately—100% of the time.

Again, the key to perfection is to capture the aggregation at each level only after the packages are already bound together.

WHERE CAN YOU BUY SYSTEMS THAT ARE BUILT AROUND THIS APPROACH?

In this essay I wanted to highlight the principle that allows RFID-based serial number aggregation to be so perfect, and which has recently been applied to 2D barcode-based serial number aggregation.  I have not done an exhaustive search to find all of the system integrators or machine builders who offer systems based on this principle.

I am not promoting or recommending any specific company, but I will say that I first became aware of this approach being used in the pharma industry by actual pharma manufacturers who were using systems made by a collaboration of four companies known as 4Serialization (which includes Omega Design).  I also know that Optel Vision has adopted the approach in systems.  I would not be surprised if there were other companies using it (leave a comment below if you know of others).  I have not worked with either of these organizations so I cannot vouch for the quality of their work.

Please do your own investigation before deciding which integrator is best for you.  The Pharmapack trade show is coming up in May.  That sounds like a great opportunity to talk with each vendor and find out what they’re capable of.  Just make sure they are following this principle and your aggregations will be perfect every time!

Dirk.