Medical Device Link.

TRACK AND TRACE

In 2006, the pharmaceutical marketplace saw the number of RFID pilots steadily increase. These pilots are being conducted both at manufacturing and distribution levels, and several supply-chain partners are also involved.

Nosco Inc. offers RFID integration into labels.

But many companies have still not started pilots. Even though FDA recommends widespread RFID adoption as the number-one way to protect the drug supply chain, FDA’s language is not strong enough. Is a government mandate needed to support FDA’s efforts and clarify and consolidate varying state pedigree rules?

BIG LEAPS

The milestones in 2006 were many. Improvements were made in tag performance in both ultra-high-frequency (UHF) and high-frequency (HF) at case, pallet, and item levels. The Gen2 standard for UHF has been ratified, and the HF standard should be completed by the end of 2007.

Given such improvements, neither frequency has emerged as the standard. Several item-level pilots have used the HF frequency, most notably Pfizer and GlaxoSmithKline. And several companies have chosen UHF, most visibly Purdue with its OxyContin pilot.

Tag cost has come down significantly from last year, and tag production is growing. Hardware and software continue to improve, helping streamline adoption, whether internally within a manufacturer, downstream in distribution, or at the retail level. With these continued improvements, RFID product and service experts can now provide a total solution based upon pilot needs. They have the capability to provide readers, antenna, integration, tag recommendations, software integration to business systems, middleware, and edge ware.

NEXT STEPS

RFID can offer ROI in managing inventory.

Congress is currently reviewing several pieces of legislation surrounding the use of RFID and other anticounterfeiting technologies for protecting the drug supply chain. If a mandate is to happen, Congress will be the driver behind it.

So what should the industry be doing regarding RFID? Get involved in a pilot and start conducting key evaluations sooner than later. A pilot means different things to different companies. Some start out small by evaluating tags and readers to help them choose tag type and frequency. Others choose to add RFID to a specific product or a specific packaging line for an on-line evaluation. Still others, like Pfizer, use a pilot to evaluate the entire process, both upstream and downstream. Industry gained significant momentum in 2006 with the number of RFID pilots initiated.

Companies should start by identifying their requirements when initiating a pilot. What is the driver for becoming involved? Patient safety is the most important reason, but other benefits can drive an ROI over the long term and increase the efficiency of the supply chain. Here are some possible areas where RFID can offer ROI:

• Safety and diversion of products.

• Returns.

• Inventory.

• Repacking.

• Validation of e-pedigree.

These are some of the best reasons to get started now instead of waiting for FDA or Congress to mandate RFID. The drug industry has the opportunity to write its own history surrounding RFID adoption and deployment.

To get started, we suggest the following checklist:

• Define objectives and metrics for pilot success.

• Assemble a project team with a specific collaborative project plan. Get as many people involved in a pilot as possible.

• Determine the entire process of tag and protocol selection, write and read strategy, and the basic infrastructure to needed to meet objectives.

• Determine inlay integration and location.

• Review the impact to packaging lines and quality specifications.

• Define whether the pilot will require additional layered authentication features, such as color-shifting inks, machine-readable taggants, etc. Test the infrastructure needed and benefits gained from these technologies.

• Launch pilot production.

• Review results and develop plans for widespread adoption.

Validating e-pedigrees can drive the safety of the drug supply chain.

RFID will change how the supply chain is managed and drive a profitable return to the bottom line. Like any other disruptive technology, RFID deployment is a marathon and not a sprint—the early stages can sometimes be confusing and expensive, and may not always show an immediate return. It’s up to us to drive the safety of the drug supply, and reduce cost through channel efficiencies.

And now that the pharmaceutical community is generally willing to share lessons learned when it comes to RFID, getting started in 2007 is far easier than it was several years ago.

Nosco is a leading producer of RFID-enabled printed packaging and has been a pharmaceutical provider since 1932. As an independent advisor and a member of EPCglobal, Nosco is helping brand owners get started with RFID with pilot preparation and implementation.