Medical Device Link.

Originally Published PMPN April 2005

BAR CODING SUPPLEMENT

While bar coding is being used effectively today to track and trace pharmaceutical products throughout the supply chain, there is also increasing evidence of its effectiveness at the hospital unit-dose level.

One good example is the recently-completed DRIVE (Drug in Virtual Enterprise) pilot, conducted in Italy between 2003–2004. The program, organized by the San Raffaele Institute in Milan and sponsored by the European Commission, was spearheaded by project manager Alberto Sanna, a member of the institute. It also included participation from pharmaceutical companies AstraZeneca and GlaxoSmithKline. The project, aimed at reducing both medical errors and costs, contained a 2-D bar coding component as well as a second phase that tested RFID.

The initial bar coding segment required 600 patients at an Italian hospital to wear bar code bracelets that were digitally enabled to be read by smart medicine carts, ensuring those patients received only the properly prescribed medicines.

In this phase, which looked at integrated patient bedside care, a "smart cart" trolley was tested for use dispensing medications in the hospital. The cart was designed to operate in tandem with labels, packages, a drug cabinet, patient wristbands with 2-D bar codes, and smart cards. The wristband contained a digital label allowing complete traceability of product code, lot number, expiration date, and other information.

Using the 2-D technology, the smart cart held drugs packaged with smart labels, which allow automatic stocking and reordering of products. Specific clinicians were recognized by the cabinet through the use of a smart card, which allowed them to stock the cart with drugs. The cart then produced a warning sound if the incorrect medication was placed in the trolley.

From this point, the smart cart was taken directly into the hospital ward. Patients' wristbands digitally provided information about which prescribed medicine they needed, which was read by the cart. In turn, the cart again sounded a warning if an incorrect patient—medication match was made.

The project utilized digital security technology, with the smart cards used for authentication and electronic signatures. Any access to patient data was dependent on the patient's user profile. A printout allowed the patients themselves to directly check on which medications they had received, and whether those medications were the correct ones at the correct doses.

Sanna, presenting this information in a conference presentation last year, revealed that 91.3% of the patients at the hospital in Milan were strongly in favor of the use of the 2-D bar coded wristband. In addition, Sanna revealed that the DRIVE study indicated that the use of the smart cart reduced the level of risk associated with the preparation of drugs for intravenous, intramuscular, intradermal, or subcutaneous administration by 71%.

The results also showed an improvement in the level of protection of patients' sensitive data and improvement of the reciprocal trust of operators in the system through the use of digital signatures.

This initial phase of the project also reportedly was successful in reducing both medication errors and manufacturing costs.

"The DRIVE pilot really proved how effective bar coding can be," says George Wright of Product Identification & Processing Systems Inc. "2-D bar codes will continue to play an important role in the ongoing development of smart labels, and this shows how well that works in a hospital setting."

The second phase of the DRIVE pilot, which was also conducted at the same hospital in Milan, utilized RFID technology for both the bracelets and medications. Preliminary results from that phase of the pilot, according to Sanna, showed RFID's effectiveness as a solution for smart tagging.

Copyright ©2005 Pharmaceutical & Medical Packaging News