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Pharma Ponders a Track-and-Trace System

At last week's RFID Track and Trace Health Care Summit, there was a great deal of focus on what state governments and the FDA will require the pharmaceutical industry to do, and less emphasis on the business value of RFID.
By Mark Roberti
In addition, you would think wealthy drug companies would be interested in using RFID to track the chemicals they receive into inventory for manufacturing, achieve inventory visibility, improve order accuracy, confirm delivery upon receipt and gain needed efficiencies in executing drug recalls. I heard no talk about any of these benefits (though I didn't attend every session, or stay for the second day).

I attended a panel discussion with representatives from two of the largest drug distributors: Ron Bone, senior VP of distribution support for McKesson, and Heather Zenk, director of integrated solutions for AmerisourceBergen. Bone made what I thought was the key point of the event: If the industry takes the five-year delay as a reason to stop its work involving RFID and track and trace, regulators will step in and tell the industry what it should be doing. The FDA and state governments won't accept the excuse that drug companies can't meet pedigree requirements in 2015.

The challenge for the pharmaceutical industry is that utilizing RFID for track and trace requires sophisticated systems that can capture data about individual bottles with 100 percent accuracy. That is possible, but it will require improvements in the technology, as well as changes in the packaging. More than one speaker said they could read every tag on 60 bottles in a case, but once they went over that number, reliability began to decrease—with both high-frequency and ultrahigh-frequency systems.

We've seen RFID systems improve dramatically over the past two years. Certainly, if the drug companies work with the vendor community to develop products, they can achieve the 100 percent read rates required for e-pedigree. But it won't happen if the industry sees the five-year delay in pedigree requirements as an excuse to do nothing. And the industry will certainly lose the public's trust if people get sick or die from counterfeit drugs. I encourage the industry to heed Bone's warning: Keep working toward a system that is reliable, protects the public and guards companies from a potential public relations crisis.

Mark Roberti is the founder and editor of RFID Journal. If you would like to comment on this article, click on the link below. To read more of Mark's opinions, visit the RFID Journal Blog or click here.


Mike Ahmadi 2008-11-24 08:37:25 AM
Security and Risk Management Still Unanswered Mark, Anyone with a modicum of intelligence can understand the potential business benefits of a "killer" application like RFID. It does not take a rocket scientist to figure that out. Where the industry is nearly clueless is in understanding the associated risks. Big Pharma is currently NOT held liable for counterfeits. The court of public opinion may or may not deliver a guilty verdict, but legally they are in the clear. Once ePedigree becomes the law of the land, that potentially changes EVERYTHING. Big Pharma is now expected to make sure the tracking system is sound, robust, and is stopping counterfeits. Perhaps the liability lies elsewhere in the supply chain, and the associated organization is held liable. These are big unknowns. Couple that information with the cost of RFID implementation, the KNOWN security pitfalls of MOST RFID systems, and the enormous task of getting everyone to agree on what to do, and we can easily see why nobody is willing to dive into this so quickly. I recently delivered an oration at an FDA public hearing regarding tracking systems for produce, and I spoke of the need for security. I was directly approached by a uniformed FDA officer who thanked me and said "The FDA is really bad when it comes to anything that is related to information technology, we need to look more closely at security." So if industry leaders, such as RFID Journal, Supplycape, ABI, etc. are not going to lead the charge for security, who is? The RFID Security Alliance is trying our best to do so, but WITHOUT the support of industry leadership our reach is limited. Perhaps RFID Journal might consider lending a hand.
Bikash Chatterjee 2008-11-25 04:21:46 PM
Pharma Ponders a Track-and-Trace System I very much enjoyed reading Mr. Roberti's article on the challenges facing pharma and biotech in complying with proposed track and trace legislation. I felt however, it is important to calibrate the challenges properly in order to fully grasp the opportunity and impediments to implementing RFID and the industry's apparent hesitance to do so. The mandate for traceability has been in place since the first recommendation by the Counterfeit Drug Task Force in 2004 and has been specified in terms of enforcement in Compliance Policy Guide 160.900 Prescription Drug Marketing Act – Pedigree Requirements under 21 CFR Part 203 December 2006. So the legislation exists. For an industry which spends literally billions on product development why hasn’t there been a rush to adopt RFID? The answer is complex but I believe lies in some fundamental truths. First there must be a tangible perceived threat to prompt the industry to jump to significantly more modern technology. For an industry that has just embraced barcoding to any significant level over the last 5 years, RFID is star wars technology. Technology adoption is always a labor intensive undertaking. In addition to this challenge we have the market and pricing challenge. The industry is not eschewing adopting track and trace because it wants to put people in harms way. The very real fact is the US pharma market is contracting. Consolidation and layoffs at all of the big pharma and biotech companies are occurring on a weekly basis as the industry attempts to look for new ways to become more efficient an drive down development costs in light of mounting pressure from the public and Congress to drive down the cost of health care. Couple this with an FDA that has stumbled badly over the last few years in terms of protecting the public and you have a highly risk averse environment for bringing in new therapies. So take the $1.3 billion it takes to develop a drug, add a couple of hundred million and several more years and you have a very challenging market and only a few years of patent protection in which to be profitable. The drive to exploit low cost manufacturing overseas as a cost cutting measure is opening the industry up to risk. Assessing that risk as part of a structured risk management model is key to ensuring the security of our drug supply. The Heparin example would not have been alleviated by RFID because the root cause was a well known additive which looks the same on test as Heparin. The problem started with the acceptance criteria and testing not with the supply chain. So to set the record straight I believe RFID technology and new emerging versions of these technologies offer the portent of tremendous advantage to the industry. However, if you do not consider the realities in technology adoption along with the drivers within this market sector you will never get your message heard.

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