Like most pharma magazines, we've been covering e-pedigrees and RFID; although we'd like to say that we've been immune to the hype surrounding this subject, we've spent an awful lot of time covering the ins and outs of the frequency debate because very few companies will discuss what they are doing. It has been a bit like covering the much-hyped process analytical technologies (PAT) in that regard. Fortunately, PAT has developed more momentum and more pharma companies are open to talking about it.
But consultant Adam Fein, who has been addressing RFID hype for quite some time in his blog, recently cited a very fine "myth shattering" article in CSO that I wish we'd published (as well as a hype-riddled blurb from a trade journal e-newsletter that I'm relieved we didn't. )
In it, the author pinpoints the top five misconceptions about RFID technology as they apply to drug supply chain protection. Here is a link to the article by Sarah Scalet, a senior editor with the CxO Media Group.
Our contributing editor and editorial advisor Emil Ciurczak, an expert in NIR spectroscopy, did address some of the limitations of RFID in a recent op-ed entitled "You Can't Cheat an Honest Man." As he suggests, PAT and powerful, inexpensive hand-held NIR and Raman spectrometers (while themselves the subject of quite a bit of hype) could be powerful weapons in the war against fakes. China just bought boatloads of them last year. Here's an excerpt from Emil's op ed.
Markers that use radio frequency ID (RFID) promise some relief. However, as with any defensive measure, the "enemy" is out there looking for counter-measures. Like hackers generating new viruses, drug counterfeiters are always seeking ways around security technologies. The problem I have with RFID tags is that they are on the bottle or case, not the product itself. Having worked in the industry longer than many of you readers have been breathing, I am aware of how easy it is to repackage products.There is little to stop a group from hijacking a legitimate shipment of a controlled substance, emptying the product for diversion, and refilling the bottles with placebos (for insertion into the retail stream). These cases of bottles, still bearing the correct RFID tags, are distributed to pharmacies throughout the region, while the diverted product is sold to street pushers or made available online.Before you start wringing your hands in dismay (who wrings their hands nowadays, anyway?), I have a humble suggestion. One of the benefits of PAT/QbD is the discovery of what is called the "process signature." It is this process signature that allows us to predict a drug product's performance vis-á-vis such things as dissolution, hardness, etc. This identifying characteristic of the product is our best defense against counterfeiters. With the advent of small, inexpensive, hand-held spectrometers (NIR and Raman), it is feasible for agents from the DEA, FDA, ATF, FBI or any other government entity to spot-check drug products in seconds.Even if the miscreants were to invest the effort to use the correct APIs and approximate the excipients, they would seldom have the wherewithal to duplicate the large, modern tableting machines used by legitimate drug manufacturers. (It is not likely that counterfeiters would make knock-offs of generic products either, the profit being too small.) That makes the key element of the "Design Space" concept a key element in law enforcement, too. If another reason for PAT was needed, we may have just discovered it, "thanks "to the counterfeiters. . . .
