Master Data, Supply Chain Master Data and Instance Data

We need to make a clear distinction between traditional Master Data (MD), Supply Chain Master Data (SCMD), and Instance Data (IData). This will help us understand some important differences in various supply chain track and trace technologies.

Master Data

Wikipedia defines “Master Data” like this today:

“…Master Data is that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the organization.”

This isn’t detailed enough for me. MD must include a data element that serves as an identifier. An identifier that refers to a given MD record must be unique within the organization.

Good candidates for MD are customer information, location information, product information and employee information. The characteristic these all have in common is that the data behind them rarely change. For example, I have been issued an employee number by my company. My employee number is the unique identifier for the MD that describes me to the company. My mailing address, phone number, marital status, social security number rarely change.

Most organizations make use of MD so that they can maintain the definition of these entities in a single place, and they can simply refer to these definitions through the corresponding unique identifier. The identifier provides a quick way to get to the full set of information. In many cases, the identifier can serve as a stand-in for the full set of information.

Supply Chain Master Data

Wikipedia doesn’t yet have a definition for Supply Chain Master Data. I’ve coined the term to describe something that is similar, but distinctly different than Master Data as described above. I’ll define it like this:

“Supply Chain Master Data is that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the supply chain.” Continue reading Master Data, Supply Chain Master Data and Instance Data

Who’s Responsible for Global Supply Chain Security?

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.

The California Pedigree Law

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.The original California Pedigree Law was passed back in 2004 and it was subsequently modified by the State Legislature in 2006 and again in 2008. In all three instances, I understand that members of the legislature and the Governor’s office worked closely with the State Board of Pharmacy to develop the final content and language.

I heard that one of the goals was to create a better law than the one in Florida. Did they succeed? In order to find out, let’s take a closer look at how they compare.

The law that is currently on the books in California differs from the Florida Pedigree Law in the following ways:

  1. It is fully electronic (it is NOT paper-based)
    The law and all of the discussion of the law by the Board of Pharmacy make it clear that the only acceptable form of a pedigree is electronic. This make it much more reasonable to implement because supply chain members can make use solely of computers to exchange, store and validate pedigrees, without fear that their trading partners can only handle paper pedigrees.
  2. Pharmacy returns must be reflected on pedigrees
    This was an original requirement of the Florida Pedigree Law too, but it was removed under pressure from lobbyists before the law went into effect. So far, it remains intact in California, but the law is not yet in effect. What it means is that when a pharmacy buys drugs from someone and they return those drugs, regardless of how little time has transpired, they must provide a pedigree update so that subsequent buyers of those drugs can see their purchase, and return transactions. This is no different from the requirements faced by all other segments.
  3. It starts with the manufacturer
    In Florida the first wholesaler started the pedigree. In California, the pedigree must be started by the manufacturer or it is not valid. If you are looking to expose the full history of package of drugs, how could you not start with the manufacturer? I even think the manufacturers generally agree with that notion.Interestingly, the Law doesn’t actually require anything of the manufacturers directly. It is directed at wholesalers who are licensed to operate within the state. Distribution of a drug without a pedigree that was started by the manufacturer is illegal and subject to penalties, but it is the wholesaler who violates the law and is punished, not the manufacturer. Thus, if a given manufacturer fails to provide California wholesalers with serialized product and compliant pedigrees by the time the law goes into effect, it will be up to the wholesaler to decide not to distribute those drugs within California in order to avoid violation of the law and avoid the associated penalties. The only risk a manufacturer takes on is that their drugs may no longer reach patients in California (and the subsequent PR firestorm that would follow).
  4. It requires item-level serialization
    California is very clear that they consider the concepts of “electronic track and trace” and “item-level serialization” as being inseparable. That is, if you have one but not the other, then you don’t have a pedigree system. Every drug package must have a unique identifier on it, applied by the manufacturer or repackager, and that UID must be included in the pedigree (the electronic record). This is a substantial difference from the Florida law which has no such requirement.
  5. No holes designed to accommodate special interests
    I’m not aware of any special treatment in the Law for any particular segment of the supply chain. Florida opened several holes that seriously compromise the intent of their law. So far, California has resisted opening holes, unless you consider pushing back the effective date to 2015-2017 a “hole”. 😉

Attentive readers will notice that I have listed these differences in the same order as my list of failures of the Florida Pedigree Law in my earlier post about the Florida Law. This is my way of showing that California has, so far, created a pedigree regulation that does not have any of the major failures of the Florida regulation.

These are the major differences, but what about the common characteristics? Here are the key things that the California Law has in common with the Florida Law:

  • Reliance on Digital Signatures
    Florida allows a pedigree to be created, stored and passed in electronic form, though they don’t require it. But if a Florida pedigree is in electronic form, digital signatures are required for the same purpose as a hand-executed signature on a paper document. The digital signature legally binds the signing person or entity to the content of the electronic document. Florida identified some specific standards that ensure that the digital signatures possess the all-important quality of non-repudiation. The California Pedigree Law does not, itself, specify any standards for digital signatures, but the Board of Pharmacy’s Q&A (see their Q72) calls out the fact that the California Code of Regulations identifies the specific characteristics that must result from a compliant digital signature architecture for electronic documents. The digital signature standards that are compliant in Florida would also be compliant in California.The fact that California included the use of digital signatures is significant because it ensures that each pedigree can stand on its own as a self-contained, self-secure package. This maximizes the value of the entire pedigree architecture because the security mechanism that prevents tampering goes with the package itself. No one has to rely on the access security of a given server or group of servers to prevent tampering. And, if tampering does occur, it can be easily detected, unlike tampering of pedigree approaches that rely solely on server access security. In that case, if server security is breached, you can’t tell which pedigrees were modified and which were not, rendering them all suspicious.
  • It distributes responsibility for monitoring supply chain security to all supply chain participants
    This is the one genius concept of the Florida Law and California retained it, thus qualifying those involved for genius status as well. It’s a regulatory approach that is relatively new but is likely to become much more common in the face of perpetual budget “crises” in state and federal government agencies. Instead of requiring trading partners to simply keep records of their own buying and selling history for each drug so that they can be audited by an inspector at some later date, these laws require them to check the validity of the full pedigree at the time of each purchase transaction, in near real-time.Notice the difference. In the first instance, it is up to the State Board of Pharmacy inspector to detect suspicious activity in the supply chain. But how often will a state inspector visit, and how many records will they be able to review? It’s inconceivable that this approach would result in the detection of illegitimate activity.But when every purchase of a drug as it passes down the supply chain requires the buyer to run a validity check on the full transaction history of that specific bottle, it greatly increases the odds that most suspicious transactions will be detected. And for most suspicious events in the history there will normally be multiple opportunities for detection. Here, digital signatures are the enabling technology. They allow all of this supply chain monitoring activity to occur reliably and automatically inside computers that are distributed throughout the supply chain, without human intervention and without slowing the movement of drugs.

So did California succeed in creating a better law than Florida? I propose that there is almost no comparison so the question may be moot. The California Pedigree Law is so much more far-reaching than the one in Florida. While Florida focused on disrupting some very troublesome practices being performed by a few nefarious licensed and unlicensed wholesalers, California’s law is designed to cause a major reorientation of the pharmaceutical supply chain approach to security, monitoring and policing (see also The Deputized Supply Chain). This has major implications that go well beyond those of the Florida law.

Faced with that, it is not surprising that it was necessary to push out the effective dates to 2015-2017. Transformation this big takes time to implement.