So why has the use of RFID in pharma become so bogged down in unnecessary complexity? Are there really so many issues to be overcome before RFID in pharmaceutical packaging shows how valuable it can be?
Let’s consider the nature of the pharmaceutical industry before we answer these questions.
Making and packaging drugs is both complex and capital-intensive. It’s also heavily regulated and policed by many.
On the drug manufacturing side, batch and quality control have long benefited from the use of bar codes that bring order to what otherwise might be chaos. And when it comes to packaging and distribution—to either consumers in the store or professionals at a healthcare facility—we’ve found ways of promoting brand identity without jeopardizing our ability to comply with labeling regulations. In other words, we’ve found ways of promoting the wonder drug “Juvenate” without obscuring the fact that what it really is is techlorisporian dycholorted methyl.
That’s the good news. The bad news is that the pharmaceutical industry has had to contend with a grey market for both branded and generic drugs and a black market for diverted drugs. It’s also in a quandary over the efficacy of some drugs. Throw in the fact that in some countries the drug supply is fraught with local circumstances involving theft and diversion, and you get a feel for what the drug industry is like.
Can RFID erase the bad news? Certainly not. But it can add a level of security and integrity that will reduce the opportunity to cause harm and add cost in the supply chain. So why haven’t we seen more progress on the pharma front?
Because too many cooks are stirring the pot. Moreover, it’s the wrong cooks doing the stirring. The packaging professionals who should be defining this issue, who should serve as catalysts for progress, are relying too heavily on systems integrators and conference organizers. The issue is being talked to death when it should be tackled and resolved.
What are the barriers to effective use of RFID in the pharma sector? Well, it’s not the numbering system. It doesn’t need to change, though there can be no question that the Electronic Product Code would be enormously beneficial in policing and tracing to a more finite level the suspect or diverted product and thus removing distribution leaks.
The packaging doesn’t have to change, either, only the means by which a package is tagged. The tagged area, particularly at the Rx level, requires a very small footprint.
The scanning of product in production doesn’t change, only the added security of automated scanning is created and the observance of the 0HIO principle (Zero Human Intervention Operations).
There are some important procedural changes that will lead to a more secure environment. These are the ability with RFID scanning equipment to maintain the thread of custody, to enable the correct drug to be dispensed more readily.
So why is there not a clarity-of-use model for RFID in the pharmaceutical industry? I see two reasons. First, because the regulatory agencies and the pharmaceutical companies aren’t on the same page. Regulators view RFID as useful but not imperative, while the pharma execs see it as useful but not mandated. Where’s the incentive? Would tamper-evidence legislation have been adopted if it were merely recommended? Without greater incentive, why would drug makers add cost to their packaging operations?
And second, the conference organizers and systems integrators have hijacked the process by which RFID should become part of the pharmaceutical packaging world. Unless that grip can be shaken, the real stakeholders in this issue—the drug makers—will never bring the benefits of RFID to the world of pharmaceutical packaging.
John Greaves can be reached via e-mail at RFID4U@cs.com.