Imitation is the sincerest form of flattery - except when it is meant to deceive. Then, it is counterfeiting. Counterfeiters fabricate art, currency, historic documents, clothing, accessories, software, stock shares or certificates, watches, or jewelry. Anything of high value can be a target, and recently pharmaceuticals have joined the list. Products attractive to counterfeiters are those that are costly, best-selling, or prone to abuse.
Counterfeiters' impact is more than just economic; it also is a safety issue. Of necessity, the FDA has had to fire up efforts to ensure that the nation's drug supply remains safe and secure.1 Authenticity is now a key concern in pharmacy's multibillion-dollar market.
First Electronic Attempt
To date, the bar code has been the only electronic aid embraced by health care, but bar-code technology has not permeated all of the industry. Nursing homes, rural facilities, and charitable organizations still are unlikely to use bar-code technology, as are organizations that tend not to adopt new technologies quickly.
Some barriers exist. Bar coding involves an initial investment of time and money. Users must pass a laser line directly over the bar code - which sometimes requires several tries. Bar codes save paper, but the technology is not paperless; documentation and backup hard copies still are necessary. A handwritten "traveler" must accompany most pharmaceuticals through the manufacture and distribution process.
As used today, bar codes generally appear only on pallets of pharmaceuticals, typically identifying the manufacturer and the product. They lack individual unit-specific identification and realtime data and often are lost when the pallet's shrink-wrap is discarded.2,3
With only 3% of the health care market using pharmaceutical bar-code technology, most patients remain potential victims of counterfeiting.4 This technology was and remains good in theory, but, in practice, acceptance is low. Electronic pedigrees rather than bar codes appear to be the logical alternative.
Dynamic Labeling - RFID
The alternative to bar codes is dynamic labeling, or radiofrequency identification (RFID). It allows manufacturers and distributors to track drug products through the supply chain more precisely and without paper. It also helps pharmacists validate individual products' authenticity.
RFID is an electronic pedigree that has existed since the 1970s,3,4 but its use in pharmaceutical manufacturing and distribution is relatively new. It is a protected record documenting a pharmaceutical's life cycle (manufacture, distribution, and storage places and conditions) on an RFID tag (or transponder). RFID silicone tags (miniscule adhesive stickers) emit radio signals via an antenna. An RFID reader senses the information stored on the tag's microchip, which usually includes the product name, lot number, electronic product code, and national drug code. RFID readers access this information for each package of product throughout the supply chain.4
Each tag currently can store approximately 2 kilobytes of data, but the technology is improving quickly.3 RFID allows wholesalers and retailers to identify, quarantine, and report suspect drugs with the wave of a wand, and to conduct efficient, targeted recalls. RFID creates the capacity to track pharmaceuticals from the manufacturer to the pharmacy. It also helps identify illicit products and jump-starts the investigatory process. The advantages of RFID over traditional bar codes are described in the Table.2-4
The Reading Process
RFID readers send signals that excite RFID tags, which then communicate with the reader. This read-write capability reduces human error associated with data entry; it creates electronic batch records. Technology - hardware and software designed for RFID, called middleware - takes the information, filters it, stores it in a database, and allows other systems to make manufacturing or planning decisions. This becomes an automatic process verification, called track and trace functionality.
The FDA is partial to this type of tracking, because the system can locate products in the process in real time, remotely, and instantaneously. Thus, pharmacists, using a simple scanning system, can trust that the product on the pharmacy's shelf is the product the manufacturer intended.4
Understanding RFID tags is easier if you think of familiar RFID systems that use "proximity," "proxy," or "contactless cards" - smart cards used to pay masstransit fares, automated toll-paying devices on cars, and building access cards at the entries to buildings.2,3 Other uses include library-book tracking, airline-baggage tracking, and apparel theft-prevention
In addition to providing a safety net, RFID enhances life-cycle management for shelf-life-specific products. For example, RFID tags can prevent shipment of products too near their expiration date, avoiding wasted shipments or product recalls. They can perform this task without paper.4 Partnering RFID tags with sensors is yet another improvement; they can then read and transmit temperature, vibration, or other important readings.3 This capability is especially attractive for products requiring specific storage and handling conditions.
The FDA published a compliance policy guide for the industry in November 2004, "Combating Counterfeit Drugs," on implementing RFID studies and pilot programs. It recommended widespread RFID technology use throughout the pharmaceutical industry by 2007.1
Agency officials are somewhat frustrated with the slow penetration of the technology into the marketplace. Data ownership is one barrier, and another is the question of who should have access to the data.5 Cost may be another stumbling block; RFID is 10 to 50 times more costly than bar coding. The least costly of RFID tags cost $0.10 to $0.50 per tag, depending on their operating frequency.3
Bar-code technology probably will remain in use for many items due to its familiarity and low cost. Manufacturers are likely to use RFID for high-cost or risky items. Scientists predict that RFID technology will become much less expensive in the near future. Economy of scale will be a cost-reduction driver1; a move to plastic tags also is predicted. Wal-Mart and the US Department of Defense are fueling widespread use of RFID in many areas, and other entities will have to follow.3 RFID is coming to your pharmacy practice soon.