Capsule Newsletter, Issue 001, June 2006

First Reports From The Field: Drug Pedigree Sheds Previous Misconceptions

By Robin Koh, Chief Strategy Officer for SupplyScape Corporation

As the first electronic pedigree systems go into production in the pharmaceutical supply chain, what pedigree is and what it is not have become more starkly clear. While the reality of implementation has resolved many questions, misconceptions persist. Prominently, the FDA's recommendation of RFID as the most efficient data collection technology for electronic pedigree raised expectations and the charisma quotient of the much-publicized technology. A common, and understandable, assumption is that electronic pedigree equals RFID. However, it does not. This and other recent myths about security systems for prescription drugs beg for clarification.

Myth #1 RFID technology is essential to electronic pedigree

Electronic pedigree and RFID have been inextricably linked in most people's minds since the FDA released its final Combating Counterfeit Drugs report for prescription drugs two years ago. The February 2004 report discussed electronic pedigree as "a secure record documenting the drug was manufactured and distributed under safe and secure conditions," and identified RFID as "the most promising approach to reliable product tracking and tracing."

RFID has been used in closed-loop commercial tracking, security, and manufacturing operations for some 25 years, but only within the last five has the vision developed to consider RFID for global logistics applications in open supply chains.

RFID indeed has tremendous potential as a data capture technology for identifying products and can be coupled with electronic pedigree as well as a host of other innovative applications. Non-line-of-sight scanning, where full pallets are read by simply passing beneath a portal, promises to open up vast new areas of efficiency and control. RFID use in logistics applications, however, is at this point still under development in real-world applications as Wal-Mart and DoD suppliers work out interference, read rate, and anti-collision issues in their efforts to meet customer mandates.

A few pioneering pharmaceuticals manufacturers and distributors, such as Pfizer, Purdue Pharma, and H. D. Smith, completed pilot RFID trials last year and are now shipping RFID tagged product. In the coming weeks, the nation's first electronic system for pharmaceuticals supply chain security is scheduled to be up and running in Pompano Beach, Florida (see "H. D. Smith, First E-Pedigree Compliant Distribution Center," below). H. D. Smith will be using RFID prescription drug serial ID numbers for identification verification within the separate electronic pedigree document. However, because most drugs today are not RFID tagged, and often have no identifying serial numbers, H. D. Smith's electronic pedigree system works as effectively using bar code IDs and no ID numbers at receiving. Effective electronic pedigree solutions can be implemented today and the data capture infrastructure, whether RFID or bar code, can be implemented later. A secure, robust electronic pedigree solution is in no way dependent upon RFID-based data capture.

Under the onus of a counterfeiting problem that grew by more than 250 percent from the 1990s to 2003, and understandably impressed by pilots and presentations demonstrating RFID's potential, members of the FDA's counterfeit drug task force in 2004 outlined a timeline for pedigree and also projected mass use of RFID appropriate for limited high-profile drug identification by July 2006, and item tracking of all drugs by 2007 (http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html). Two years ago, the FDA could not have anticipated the delay of a robust Generation 2 standard for RFID tags, or the difficult, impediment-littered development curve of an evolving technology in a wholly new application.

Distributors who focus on biologics and vaccines such as FFF Enterprises do not have the benefit of RFID either, but for a different reason. RFID vendors are still refining the physics of RFID with liquids and metals to improve the read rates necessary for high volume data capture.

Myth #2 Mass serialization is essential to the drug pedigree.

Many people assume that each bottle must be serialized for electronic pedigree use, but this is myth. In 2004 the FDA also stressed the importance of mass serialization in pedigree applications as "the single most powerful tool available to secure the U. S. drug supply." This statement presupposed the widespread use of RFID for data collection by 2006, as well as a globally or locally administered mass serialization system entering commercial use. However, the slower adoption of mass serialization and RFID readiness in no way precludes electronic pedigree use. Though desirable, serial IDs are not necessary for stakeholders to match the pedigree to the drug since it is possible to associate the pedigree and drug by operational means.

The following two distinctions help put the relationship between electronic pedigree and mass serialization in perspective.

Point vs. Systemic Counterfeit Identity Detection:

There is a significant difference between point identity detection of counterfeit; for example, the ability to tell if a particular drug bottle is fake or has been tampered with, versus the systemic identification of widespread counterfeit activity. Systemic fraud, such as the introduction of 50,000 cases of counterfeit product into the legal pharmaceutical supply chain, is far more worrisome.

Electronic pedigree without serialization can help identify systemic fraud by verifying the number of cases against the number of electronic pedigrees received by a particular facility. It will be challenging to introduce large quantities of fake product into the legitimate supply chain as the flow of electronic pedigrees is kept separate from the actual movement of goods. Potential perpetrators will have to compromise both the information system and materials system to synchronize the pedigree verification process. The detection and deterrence of large-scale fraud is an important first step. Subsequent development of end-item serialization by the industry will further strengthen supply chain security and lead us to the ideal capability of point identification of counterfeit.

Item vs. Case Identity:

In some situations, a case may be serialized but the individual bottles within it are not. Electronic pedigree software associates items and their pedigrees with the cases that they are packed in. That documented association is effective for secure track and trace, even if individual bottles are not uniquely identified.

Myth # 3 Differing state pedigree details result in incompatibility.

Since each state sets regulatory requirements for all prescription drugs passing within and through its borders, some have raised the specter that interstate drug shipments will have to navigate incompatible state pedigree requirements. In fact, all the major electronic pedigree systems suppliers have committed to interoperability as part of using the EPCglobal pedigree format. Even if the states currently working on electronic pedigree legislation differ in some specifics, the EPCglobal format was developed as a superset of all state requirements. In cases where states, like Florida, accept paper pedigrees as well as electronic, conversion to electronic document is addressed by the format.

Myth #4 ASN or RxASN is equivalent to an electronic pedigree document.

One suggestion is that wholesalers can initiate an electronic pedigree by reformatting the identifying shipment data transmitted to them from the manufacturer via ASN (the Advance Shipment Notice transmitted in standardized EDI format). However, the ASN is designed for a wholly different purpose (notice of an impending shipment) and contains minimal shipment data. ASN content is nonstandard and is subject to each customer's requirements.

The RxASN, a relatively new concept, contains much more granular data including drug and logistical information necessary to fill out the electronic pedigree details. Some major pharmacies and wholesalers want to receive an RxASN before they receive the drug shipment, in order to streamline their receiving process. An RxASN is not an electronic pedigree; it lacks nested transactions to document the upstream chain of custody, digital signatures, and the authentication process that ensure security in an electronic pedigree. While RxASN is not considered a legal document, as is the electronic pedigree, the details in the RxASN can be useful in populating an electronic pedigree.

Pedigree Now

Finally, the luxury of waiting and seeing just is not there; in the next few weeks many of these issues will have to be bulldozed out of the way. Delays caused by reaching for perfect technology are going to be very costly. A better approach is for each stake holding company to assess and quickly resolve how it will enable pedigrees for secure drug distribution.

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