Clearing the Bar

At the present moment in time, the future of bar codes in the pharmaceutical and medical device industry is appropriate to contemplate. Never before has there been so much technology ready to implement. However, as an industry we must think about the healthcare system as serving the customer rather than individual sales points.

Since the turn of the century, a lot has happened in related industries. The aircraft industry has provided unique identifiers on all the safety-critical parts. While counterfeiting has not been eliminated completely, the frequency of world headlines about plane crashes from part failures (caused by counterfeits) has all but disappeared.

The automotive industry has supplemented alphanumeric vehicle identification numbers (VINs) with bar codes across most of car and light truck production. Although there have inevitably been some savings for the car makers themselves, big savings have been realized by service providers (dealers) and law enforcement. At the same time, most car parts have been coded with bar codes to facilitate identification and billing. The 2-D UV bar code, discussed as a breaking technology in our March 2001 PMP News article “Bar Code Supplement: Raising the Bar” (www.devicelink.com/pmpn/archive/01/03/004.html), is now the standard way of marking rubber gaskets and other visible parts. Many of the major pharmaceutical companies are also using this as a covert marking system for injectable products and clinical trial materials. But as a covert system for blind clinical trials and anti-
counterfeiting, such marking really isn’t discussed.

Likewise, the automotive industry has implemented its form of radio-frequency identification (RFID) as transponders for the tollways in various states. Unfortunately, the read rate is not 100%, so the system must make up for misreads with a camera system. With cars moving through tollways, each is oriented front to back and within a closely defined lane, so video cameras can capture the front or back license plate and bill the appropriate vehicle for the toll.

This scheme gives an indication for the direction of RFID and bar codes. The tollway RFID is wonderfully simple and accurate when it works. However, any read rate less than 100% in all circumstances requires a reliable backup—a readable license plate of sorts. With automobiles, there are license plates and bar coded vehicle identification numbers (VINs), whereas with pharmaceuticals and medical devices, bar codes and lot codes are used.

HIERARCHY OF CODE BACKGROUND

An invisible 2-D Data Matrix code printed on a vial. Photo courtesy Diamond Machine Werks and Weiler Labeling Systems.

The coding of products has gained sophistication with the development of society and the systems that deliver goods.

Brand image is the oldest means of product coding. Ancient civilizations marked clay pots with shapes and pictorial designs to indicate content. Modern supermarket shoppers still use brand images, such as the look and feel of products, to quickly identify their favorite brands. The packaging world is littered with tales of radical brand image changes that lost customers simply because the known product didn’t seem the same.

Alphanumeric copy in pharmaceutical and medical device labeling is strictly regulated and well controlled by FDA or equivalent agencies in other countries. Patient directions, precautions, lot numbers, and expiration dates are all part of the approved copy. The copy claims determine liability and appropriate use of the product and are usually the final level reviewed before consumer selection. Should product follow-up be required, expiration dates and lot numbers are used for patient communication and appropriate recalls.

Bar codes were developed in the 1950s to facilitate machine reading of codes representing products. Initially, they were used only as inventory trackers until 1974 when the first grocery store began using them for billing groceries to customers. Later in the early 1980s, diagnostic companies like Abbott Laboratories began using bar codes on unit doses to automatically indicate to the diagnostic equipment which test protocols they were to run. In the late 1990s, PCs became fast enough to drive ink-jet printers with different serialized bar codes at line speed; these printers were first implemented in a supplemental 2-D UV bar code by Searle-Pharmacia on its product Dynastat/Rayzon/ Xapit (Parecoxib-Sodium). This 2-D UV code was used because there were no (and still aren’t) regulations on invisible codes. Codes were printed and available to be used, but were only utilized as a covert anticounterfeiting measure and were not unveiled for public use.

RFID predates the invention of bar codes by over a decade. Active RFID was initially used by the British to determine whether incoming planes were allies or Nazis during World War II. As with everything electronic, though, the price has been plummeting from the initial thousands of dollars per item to the now-promised $0.05 tag. Although inroads have been made in the Wal-Mart supply chain, the most visible use of RFID for most people is as a device for open-road tolling on toll roads around the world.

Use data are contemplated for the future as an amalgamation of identification of product identification, patient identification, and use information. The best example of integration of this data is with the beef ranchers/farmers of the United Kingdom. (See the sidebar on page 62.) In their case, an RFID and/or bar code is affixed to an animal shortly after birth, bar coded feed and medicine are computer-tracked to each animal, and the supply chain can be traced all the way to the steaks at the grocery store. This was required to assure consumers that British beef is free of mad cow disease.

(click to enlarge)

Depending on market sophistication, all the aforementioned types of codes will be required. Even if the infrastructure evolves for RFID, bar codes must be in place to pick up read failures; alphanumeric coding must be available for those consumers who have no reading devices; and pictorial/brand imaging present to facilitate selection and discourage mix-ups.

Use data (or metadata) are the underlying drivers that give any type of code value. The code is the simplest way to access and link broader information about an item, whether the item is a product, a patient, or a record. IT systems log and manipulate information to achieve the desired outcome through physical world transactions with unique product identifiers. Key to system efficiency is making robust acquisition of the unique identifiers and the associated parameters as easy as possible.

As the healthcare industry increasingly uses computers to integrate information to individual products and patients, more sophisticated codes, such as unique identifier bar codes, need to be added to packages and products.

Bar codes also facilitate the needed data for “pay-for-service” products and services, which are supplementing simple sales of hard goods transactions.

In the pharmaceutical world, tablets are sold with a pedigree, pharmacoeconomics showing value, and clinical results showing efficacy. The patient believes these tablets will accomplish a desired effect, but in their individual case, this may not happen. Under these current regimes, the patient pays for the promise of improved health. When this promise appears to be broken owing to bad results, patients get upset and lawsuits are filed.

As more sophisticated treatments and more personalized medicines are offered to frugal patients and insurance carriers, the payers increasingly move toward a system that pays for results.

Also, as the level of care increases, there is an increasing requirement for transaction tracking and increased metadata to associate. Computers make this all feasible, provided there are cheap and reliable input means. Unique bar code identifiers have proved themselves and will increasingly be used.

Finally, if there is a true magic bullet to prevent counterfeiting, it will need to be associated with inexpensive unique identifiers associated with product metadata. A major part of the solution will be bar codes, because they have proved themselves to be produced so cheaply and reliably, are well understood (even by consumers), and the already common bar code reading technology is on the verge of being as ubiquitous as camera phones.

A packaging professional’s part in this future is straightforward. Begin adding serialized bar codes to your product, so the rest of the healthcare system can start using them for im­proved efficiency with your product.

For noncommercial and nonproprietary discussions, the authors can be contacted at the following e-mail addresses:

Ralph Dillon: csa_chicago@yahoo. com or anticounterfeiter@yahoo.com
Joseph Noferi: csa_chicago@yahoo.com
Feargal McGroaty: fmcgroaty@stjames.ie