RFID technology will be a critical tool for combating drug counterfeiting and improving public safety. The question for pharmaceutical companies is where to start and how best to deploy RFID technology in complex supply chains. This article examines some of the key considerations and opportunities for RFID solutions in the pharmaceutical supply chain.

Symptoms of a Problem

The World Health Organization has estimated that from 5 to 8 percent of the trade in pharmaceuticals worldwide is counterfeit. Given that the pharmaceutical market is over $500 billion worldwide, counterfeiting is clearly a multibillion-dollar problem. Worse, it’s a problem that can affect the health and safety of the millions of people who – knowingly or not – purchase counterfeit pharmaceutical products.

The U.S. Food and Drug Administration (FDA) stated in its February 2004 anticounterfeiting report that RFID represents one of the most important tools to help improve the safety of the drug supply chain. Taking it a step further, the FDA has asked pharmaceutical industry players to pilot track-and-trace solutions based on RFID and related technologies such as mass serialization and electronic drug pedigrees by the end of 2007.

Stronger requirements to safeguard the drug supply chain are coming. States, with Florida leading the way, are legislating pharmaceutical product tracking and tracing through the accumulation of a product pedigree, which details specifics about the supply chain history of each drug shipment. Foreign countries, with Italy leading the pack, are also moving in this direction. More state and perhaps national legislation is sure to follow.

In addition industry associations such as the Healthcare Distribution Management Association (HDMA) have published position statements advocating the accelerated adoption of electronic track and trace using EPC tagging. Specifically, the HDMA calls for adoption at the case level by the end of 2005 and at the selling unit level by 2007. At the same time, RFID standards groups such as EPCglobal are quickly exploring what standards and new practices need to be established to adopt electronic track-and-trace technologies throughout the supply chain.

Prescription: RFID-Based Product Authentication and Drug Pedigree

The combination of an attractive, high-dollarvalue target and the relative ease of access to the supply chain puts this industry at high risk economically and legally. Therefore, investment in improved drug counterfeiting countermeasures such as RFID and related technologies is not only a good business decision, but will become mandatory.

Key industry players are already beginning to invest considerable energy and money in deploying RFID. For example, Pfizer announced in November 2004 that it will put RFID tags on all saleable units of Viagra sold in the U.S. by the end of 2005; GlaxoSmithKline has made a similar pledge; and Merck, Novartis and other companies are running a trial that tags individual items to detect dispensing errors and counterfeit drugs before they reach patients.

In fact because many of the large pharmaceuticals are working on multiple RFID projects, Sun Microsystems is helping companies develop a global RFID approach and architecture. Rather than implement separate solutions for each RFID project, we’re establishing common shared services and infrastructure that can be used by different RFID applications. As volumes increase and multiple projects come online, a more planned approach helps companies better manage data volumes and leverage enterprise services such as role-based security and back-end integration.

Tackling the Complexities of the Pharma Supply Chain

Specific aspects of the pharmaceutical supply chain can make any type of track-and-trace solution very complex and challenging. The worldwide supply of pharmaceutical products represents a unique case of the manufacturing- distribution-consumption supply chain.

In a general sense pharmaceutical products follow a similar supply path as other retail products. But drugs typically follow a more disjointed supply chain than other manufactured items, often being sold from one distributor to another to balance stocking levels (as many as 10 distributors or wholesalers may handle a drug before it finally gets to a retailer or end user). A given distributor may carry up to 40,000 stock keeping units. And drugs are often repackaged within the supply chain. Maintaining pedigrees on this volume and variety of product can be overwhelming with current identification and tracking methods.

While bar code solutions may cost less in the short term, there are a number of shortcomings, compared with RFID, that limit their effectiveness over time. For example:

• RFID has the capacity to store larger amounts of information and can be read far faster than bar codes (40-plus reads per second, compared with one to two for bar codes), and requires far less human involvement.
• Bar codes require a direct line of sight to be read, while RFID tags do not. In addition, the bar code must be able to survive on multiple types of printed media in harsh conditions, sometimes over long periods of time.

Technological Underpinnings: EPC-Enabled Authentication, Track and Trace

Subsequent to manufacture, pharmaceutical safety depends on critical supply chain controls. “Track and trace” attempts to address some of the safety and security issues. For example, pharmaceutical products often require strict control of storage/transportation environments such as temperature. Also, products may have expiration dates beyond which the product should not be dispensed. Track-and-trace processes offer the documentation needed to ensure these safety requirements are met.

However, track and trace in our current environment can be relatively ineffective. For the most part, track and trace is reactive instead of proactive due to the reliance on manual procedures and storage of information on paper. Therefore, the most frequent application of track and trace occurs in drug recalls – where there is an imminent health risk.

Through the use of EPC technology, products can be tracked and traced more easily. Any person who has access to information along the supply chain can find out the historical background on a particular drug, as well as its current location. EPC technology verifies information at every point along the supply chain, which helps ensure product integrity.

EPC technology employs RFID tags, which are physically placed on vials or bottles, drums, boxes, cases and pallets at the beginning of the supply chain. RFID tags are read by RFID readers, which can be placed at fixed locations such as dock doors or can be used in handheld form. The readers and tags collect and convey information all along the supply chain.

In EPC verification, goods are scanned and status is checked. Status can come back as okay, expired or recalled. As products move through the supply chain, the RFID tags enable them to be tracked. Information is gathered about the current location of the shipment and other vital statistics. Figure 1 is based on work Sun did with MIT Auto-ID Center (now MIT Auto-ID Labs) to investigate opportunities for securing the pharma supply chain.

In addition to EPC tagging, mass serialization can be used in multiple ways to track and trace products. One example is the use of randomly generated serial numbers, which also provide an authentication mechanism since the codes are essentially impossible for counterfeiters to guess. At established points in the distribution network, the serial number is verified against a database of authentic codes.

Authentication can also be done at the consumer level. For example, the consumer could enter the code using the Internet or a telephone to ensure that the product is genuine. In either case, if there are multiple hits of the same number, you may have a problem within the supply chain.

Pedigree Management: Smarter With RFID

The combination of origin data and chain of custody data is referred to as the electronic pedigree. Sun has partnered with SupplyScape, the leading provider of pharmaceutical electronic pedigree solutions. Figure 2 shows a simplified yet typical pharmaceutical supply chain (including repackaging) using EPC and RFID technology to manage pedigree data.

Products leaving the manufacturer ship with initial data in the EPC and in the manufacturing database. This EPC tag contains a unique serial number which can be linked to the lot number, unique product type NDC identifier and manufacturer. Implicitly this data back references, at a minimum, raw material sources and lots, date of manufacture, location of manufacture and shipment date.

The shipment is received by the wholesaler, who authenticates the shipment and eventually ships the product to the second wholesaler. The first wholesaler adds information to the pedigree which includes at a minimum, where shipment originated, name of wholesaler, quantity/container size, location, the date of receipt and certification that authenticity was verified (digital signature).

When the product is reshipped to the next wholesaler, additional pedigree information is logged and then provided in advance to the next handler. Typically, this would include certification of authenticity upon shipment, date of shipment, conditions of storage (if needed) and new quantity and package information since often the original received shipment would be broken down and repacked for shipment to multiple destinations.

Sun’s RFID Industry Solution Architecture

Sun is now building a series of RFID industry solution architectures (ISAs). These architectures are detailed guidelines that provide a strong, tested design that can be used to meet immediate requirements while laying a foundation for long-term business benefits.

The Sun RFID Pharmaceutical ISA solution includes products and technologies from Sun and its partners:

• Sun Java System RFID Software, including an event manager and information server, which collects, filters and logs RFID tag data. It complies with the latest applicationlevel events and EPCglobal specifications, and includes a browser-based, centralized management system that provides a view of the RFID network.
• RFID readers, which scan RFID tags and pass the information along to the Java System RFID event manager.
• RFID printers and applicators, which are capable of programming the RFID tags with the appropriate data.
• Integration middleware, which forms the conduit that takes data from Java System RFID software to the enterprise integration system application.
• Electronic pedigree application, which enables creation and maintenance of certified drug pedigrees, either for one or multiple parties in the supply chain.
• Product authentication services, which enable authorized supply chain partners and customers to verify a particular product EPC over the network.

Sun offers other RFID solutions such as the Sun Java System Tag and Ship offering, which provides a retailer/Department of Defense mandate compliance solution. Customers can use the same RFID middleware foundation to address all their RFID applications, including electronic pedigree.

RFID technology is still emerging, and the full spectrum of benefits of RFID will not be realized for several years. Establishing the base RFID infrastructure today is a critical first step and a key driver for total supply chain adoption. RFID is more than an exciting technology; it is an opportunity to improve supply chain efficiency and more importantly, public safety.