There was a time when RFID, or radio frequency identification, was hailed as the silver bullet for pharma supply chain safety and security. Tiny RF chips could hold vast information, from lot numbers to shipping temperature histories, and transmit the data seemingly effortlessly to manufacturers and their supply chain partners. It was the same essential technology that changed the paradigm of our highway tolling (with EZ Pass and similar automated systems), the thinking went, so why couldn’t it do the same for our drug superhighways?
This was about the same time that high-profile counterfeiting cases were making headlines. Author Katherine Eban’s Dangerous Doses, released in the spring of 2005, painted a horrifying picture of how easily critical drugs could be diverted and tampered with—within U.S. borders, no less. Manufacturers such as Pfizer (Viagra) and Purdue Pharma (Oxycontin) were launching major RFID pilots, tagging products as far down as the unit level (via tags inlaid in bottle labels, for example) for end-to-end supply chain oversight. Many of these pilot projects, though challenging, were heralded as great successes.
But behind the scenes, the picture wasn’t as rosy. RFID at the item level was expensive even for tracking high-value drugs, technologies were raw and rapidly changing, and standards were being hotly debated. When push came to shove, and budgets were consulted, barcodes became the preferred means of registering and tracking bottles, bags, and blister packs. (See, for example, “The Path to Epedigree: Manufacturers Chart Their Course.”) 2-D barcoding is cheaper and simpler, while initial concerns about their not being fast or robust enough to accommodate certain production speeds have now been put to rest.
But RFID has continued to make inroads as a technology used on shipping cases and pallets, for obvious applications such as monitoring temperatures of cold-chain shipments. And it may yet crop up again as an item-level technology. There’s been a recent resurgence in interest in RFID, says Jeremy Friedler, senior consultant for Supply Chain for Maxiom Group, which “has led some to believe that the promise of the technology may have reached a tipping point. This proves that amazing things can happen with revolutionary technologies when everyone takes a deep breath, relaxes, and remains patient.”
So news of the demise of RFID within pharma has been greatly exaggerated. Counterfeiting and other supply chain quandaries have only grown, Friedler notes, while RFID chips and readers continue to improve and drop in price.
There are still some sticking points, however, particularly in relation to biologic products. RFID potentially has the greatest value in monitoring biologics (in that they require strict temperature monitoring), but there are still lingering concerns, at least within FDA, that the RF waves could measurably impact bio-based drug products. The Agency’s 2004 guidelines regarding the use of RFID exclude biologics until enough testing has been done to show that RF does not, for example, heat up product or damage its protein bonds. As a result, biologics haven’t been part of major pilot studies.
Two research faculty from the University of South Florida Polytechnic, Ismail Uysal and Jean-Pierre Emond, are working to put such fears to rest. (Read our full interview with both here.) They’ve recently conducted studies of some 100 biologic drugs from eight different manufacturers, and have concluded that various ranges of RF frequencies used in common biopharma applications—from high-frequency (13.56 MHz) to ultra high-frequency (even up to 2.4 GHz)—have no impact upon the product.
In the past, some biologics manufacturers have been reluctant to participate in such studies, perhaps out of concern for what might be revealed about their products. Uysal and Emond, however, received initial technical support and funding from Abbott Labs to begin the studies, and further assistance from PDA’s Pharmaceutical Cold Chain Interest Group in reaching out to other manufacturers. The manufacturers weren’t exactly forthcoming with lavish details. Testing methods each used were proprietary, and results provided were essentially yes (i.e., there was an adverse effect) or no answers.
Other researchers have looked at whether or not RFID has a thermal impact—that is, the radiation causes a rise in temperature that might alter the product—and have concluded that there are indeed slight temperature changes, but that they pose no risk to the drugs or those taking them. Uysal and Emond’s work, relying upon temperature-controlled anechoic chambers, considers whether any changes in protein structure would be caused by the magnetic (for HF) or electromagnetic (for UHF) radiation resonating from the RFID devices.
The two have presented their work at several conferences, and hope that FDA has taken notice. “But science shows both the thermal and non-thermal effects of RF are insignificant and we hope they will take note of this.”
Breakthrough technologies like RFID should rightly be scrutinized for their potential drawbacks or dangers. But once that’s done, they should also be embraced if they truly can make a difference, as RFID can in the drug supply chain.