Dublin, OH (Nov. 14) - A half-year Cardinal Health (www.cardinal.com) study of radio-frequency identification (RFID) tags "under real-world conditions has demonstrated that the technology has real promise to provide an added layer of safety,” according to Renard Jackson, the company's vice-president and general manager of global packaging services, in a prepared statement.

Billed as "the first end-to-end test of a technology that could further improve the safety and efficiency of the nation’s pharmaceutical supply chain," the program tested whether RFID tags "could be applied, encoded and read at normal production speeds during packaging and distribution of pharmaceuticals."

“While our pilot demonstrated that using UHF [ultra-high frequency] RFID technology at the unit, case and pallet level is feasible for track and trace purposes," Jackson said, "a great deal of additional work needs to be undertaken by stakeholders across the industry to address significant challenges including global standards, privacy concerns and the safe handling of biologics."

RFID labeling and online encoding

The pilot program used new technology to place RFID tags on the labels of brand-name, solid-dose prescription drugs, then encoded electronic product code (EPC) standard data at the unit, case, and pallet levels during the packaging process. The products were shipped to a Cardinal Health distribution center in Findlay, Ohio, where the data was read and authenticated as products were handled under typical operating conditions. (The program used RFID hardware and software from Alien Technology Corporation [ Morgan Hill, CA, www.alientechnology.com] and IBM [White Plains, NY, www.ibm.com], along with project management support from VeriSign [Mountain View, CA, www.verisign.com].)

From Findlay, the tagged product was sent to a pharmacy to further test read rates and data flow, using the same technology as the distribution center. The product dispensed to patients was not in the RFID packaging.

The company launched the pilot in February and completed the test this fall. (Cardinal is also working with Pfizer [New York, NY, www.pfizer.com] on a separate RFID pilot to authenticate "Viagra" shipments at its Findlay facility.)

The study found that it is feasible for RFID tags to be inlaid into existing FDA-approved pharmaceutical label stock, and applied and encoded on packaging lines at normal operational speeds. Cardinal encoded labels at rates of 95–97%, and is optimistic that near-100% yields are possible, with "minimal adjustments to current labeling and packaging lines."

RFID read rates

The study found that unit-level read rates "varied widely depending on the locations and type of reading stations" (see Table I).

Table I. Pilot program read-rate data.

Item-level read rates

Case-level read rates

Product A

Product B

Product A

Product B

Unit-encoding yield during packaging

97.7%

94.8%

NA

NA

Unit-to-case aggregation

96.9%

99.7%

 91.8%

100%

Case-to-pallet aggregation*

56.4%

80.8%

100%

99.7%

Shipping pallet from packaging facility*

9.2%

14.3%

82.3%

100%

Receiving pallet at distribution center*

7.8%

9.5%

76.3%

100%

Receiving case at distribution center

92.1%

97.1%

99.4%

100%

Reading totes at distribution center

NA

99.5%

NA

Shrink wrap tote carts at distribution center

NA

64.1%

NA

Shipping from distribution center

NA

46.1%

NA

Abbreviation: NA is not applicable.

The tested systems could read individual cases and mixed totes better than 96% of the time, Cardinal reported. The study system had less success in reading unit-level tags within full pallets of product. The Cardinal report says that fine-tuning both business processes and hardware could possibly push case-level read rates toward 100%.

The study examined the pick-and-pack process, in which orders are assembled in totes, often commingling tagged and untagged products, for shipment to the pharmacy. "The unit-level read rates from the tote containers…during the quality control phase were acceptable for track and trace," the company reported, although "[a]dditional unit-level read rates while the product was in the tote containers were not found to be reliable during subsequent reading stations at the shipping dock of the distribution center and the receiving doors at the pharmacy." 

Conclusions

The report concludes that RFID technology using UHF at a single frequency at the unit, case and pallet levels is feasible for track and trace, though several challenges remain. In particular, technology and process improvements must boost case-level read rates to more than 99% at all reading stations, and unit-level read rates must also exceed 99%, at both the distribution center and the pharmacy.

Moreover, the report calls for changes that would:

• Allow unit-level “inference” to become acceptable practice in the normal distribution process at stages where unit-level read rates are unreliable, but case level reads approach 100% (*stages marked in Table 1);

• Allow barcode technology to be used to complementary and back up RFID;

• Manage RFID costs;

• Improved collaboration across the industry to improve efficiency.