RFID is Dead...

RFID is Dead…at Unit Level in Pharma or so says Dirk Rodgers, an industry veteran and active blogger.

Supported by excellent data, Mr. Rodgers in his opinion blog RxTrace.com posted a very good op/ed regarding RFID and its place within the pharmaceutical supply chain.

RFID technology originally developed as an inventory management tool was considered the panacea to the issue of fraudulent, adulterated and counterfeit medications by many industry insiders but their implementation and use as a solution has fallen short.

Bogus medications have now proliferated into a $75 billion annual worldwide criminal activity as the pharmaceutical supply chain has become more global.

In Mr. Rodgers' piece, he gives the historical perspective, graphs on costs, supply chain perspectives and insight into the reason that RFID has failed and will continue to fail as the ultimate solution within the supply chain.

Mr. Rodgers' concludes that RFID still has a place for use in bulk/case containers but feels that barcodes on individual units will ultimately become the norm because of costs.

Secure Pharma Chain Blog agrees in essence with Mr. Rodgers' case regarding RFID and barcodes. Ultimately we believe that tags, barcodes and other track and trace technologies are effective in what they do and that they are an import part but not the definitive solution to solving the issue of fraudulent, adulterated and counterfeit medications. Unfortunately these technologies only tell you information on the transaction and packaging.

What is most important in supply chain security is what is inside the box.

Secure Pharma Chain Blog believes in a multiple layered approach that includes transactional tracing but ultimately relies on material identification of the product to authenticate the product as it migrates throughout the supply chain.

To read Mr. Rodgers' entire blog, visit: http://www.rxtrace.com/2010/04/rfid-is-dead-at-unit-level-in-pharma.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+rxtrace%2Fvqly+%28RxTrace%29.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

Markets and Markets: Global Anti-Counterfeit Market for Food and Pharmaceuticals Worth US $79.3 Billion by 2014

According to a new market research report, ‘Global Anti Counterfeit Market for Food and Pharmaceuticals (2009-2014)’, published by Markets and Markets (www.marketsandmarkets.com):

• Increasing cases of counterfeiting have resulted in implementation of anti- counterfeit technologies. Anti-counterfeit technologies are of two types namely authentication packaging and track and trace packaging technologies. North America holds a major share of the global anti counterfeit market. Asia has the highest growth rate due to untapped market and significant level of counterfeiting. Europe has a lower growth rate due to a relatively lower number of cases of counterfeiting.


• The global anti counterfeit packaging market for food and pharmaceuticals market is expected to be worth US$79.3 billion by 2014, with an estimated CAGR of 8.6% from 2009 to 2014.


• The North American packaging market is expected to account for nearly 62% of the total revenues. North America is the largest segment in the anti-counterfeit market and is expected to reach US $49 billion by 2014, accounting for nearly 62% of the revenues growing at a CAGR of 6.8%.


• Asia is the second largest market and is expected to reach US$14 billion by 2014 with a highest CAGR of 19.7%.

While XStream Systems feels that the data presented in this report is valid it believed that Markets and Markets may have overlooked significant technology solutions in their research.

Most of the report seemingly centered on packaging technologies and ignored material screening technologies such as XStream’s XT solutions which allow the end user to verify the authenticity of a material inside its sealed unit of sale container.

How large is this market if material screening technologies were included in the mix?

To view a synopsis of the report, visit:
http://blog.taragana.com/pr/marketsandmarkets-global-anti-counterfeit-market-for-food-and-pharmaceuticals-worth-us793-billion-by-2014-5427/

RFID Not Embraced by Pharma Industry as Anti-Counterfeiting Measure

A report put out by IDTechEx states that less than 1% of the RFID market was used by the Pharmaceutical Market. The global market share for RFID was $5.56 billion up 6% over last year but only 10 million tags were used in the pharmaceutical industry.

So why wouldn’t the pharma industry embrace it after 7 years of a highly intense campaign for its adoption as an anti-counterfeiting tool? The answer comes in its use.

It is primarily an inventory management security tool. You will see RFID tags on items at your local Wal-Mart. You will see them on all your computer software and that new video game that just came out, but not necessarily on Grandma’s medicine.

The truth is -RFID is very helpful at managing your inventory. It will tell you how much you have on stock. Some tags will even beep at the door if someone tries to make off with it without paying. It does help against shoplifting and employee theft. But it does not tell you what is inside. You are still only verifying the package.

To view the article discussing the report visit www.SecuringPharma.com.

IDTechEx is a knowledge based company specializing in RFID smart labels, smart packaging and Radio Frequency Identification RFID. The company gives strictly independent marketing, technical and business advice and services on these subjects.

Track and Trace versus Inspection and Authentication Technologies?

In a comparison of Track and Trace versus Inspection and Authentication technologies it is apparent that Track and Trace solutions such as RFID, bar coding, holograms, tracing and pedigree products are not a one-size-fits-all solution to protecting the domestic and global pharmaceutical supply chain.

Track and Trace products might be sufficient, when employed throughout the Supply Chain to protect it from Drug Diversion which is one source of counterfeit activity, but these Track and Trace technologies cannot provide full protection for the product within the package. For example, how can anyone expect a Track and Trace product to determine if, either in the manufacturing or distribution process, the wrong ingredient was purposely or accidentally added into the product? Pedigree or Serialization may help, after a threat has propagated to the general public and was detected by other means, to help backtrack to the source of the problem. But by then it may be too late and the consumer will have already suffered.…

Only through the use of Inspection and Authentication technology such as XStream Systems’ XT250 Pharmaceutical Authentication System can those within the drug supply chain immediately inspect and authenticate the product within the container. Don’t let problems reach the general public. Stop the issues in their tracks.

For more information on XStream Systems and the XT250™ Pharmaceutical Authentication System, visit their website at www.xstreamsystems.net.

Making a Killing: The Deadly Implications of the Counterfeit Drug Trade

This book written by Roger Bate and published by American Enterprise Institute for Public Policy Research is an excellent encapsulation of the growing danger that is facing consumers globally. In his book Bate masterfully researches the history, scope, globalization, causes and current solutions on the issue of counterfeit pharmaceuticals.

Unfortunately this is an issue that far too few industry and government thought leaders are aware of, adequately educated on or are taking the proper steps to protect their company or constituents against.

Bate recommendations seem to be fixed primarily on dated technologies such as e-pedigrees and RFID as the answer to protecting the drug supply chain. Regrettably he seems unaware of other technologies like XStream Systems' XT250 that can authenticate medications inside a sealed container and which teamed with or in a standalone fashion can properly protect inventories throughout the global and domestic pharmaceutical supply chain. Here’s hoping that as Bate follows up on this well written book, he goes beyond his excellent foundation of the issue and deeper and further in researching potential solutions.

All-in-all, Making a Killing is an excellent book that is a must read for everyone involved in the healthcare industry and the pharmaceutical supply chain.

What the True Pharmaceutical Security Focus Should Be: Authentication

As many of those who have spent many years within the Pharmaceutical Supply Chain, I watch the major players within the pharmaceutical industry jockey and debate the current initiatives that are intended to secure the safety and efficacy of the medications that we in the United States take daily.

In this era of globalization we in the United States find ourselves increasingly consuming medications that use foreign produced raw materials, outsourced manufacturing and are packaged overseas. Although most of these efforts are managed and regulated according to tight corporate and FDA scrutiny, serious issues have arisen recently which demonstrate nefarious intent to circumvent the safety and security of these globally produced products.

Additionally we find international and domestic criminal organizations, realizing the potential of high profits and low risk, using sophisticated operations to adulteration, dilute or counterfeit medications that make their way into our drug stores and healthcare providers.

The threats to our safety as a nation are real. The danger that contaminated, adulterated, diluted or counterfeit medications that our population currently faces is increasing every day.

Unfortunately we find that there are few deterrents or regulatory processes in place to adequately protect our population from these sophisticated threats to our collective health.

Currently the Congress, Federal and State regulatory agencies are grappling with the most effective way to deal with this clear and present danger. To date most if not all of their efforts have been focused on track and trace technologies and protocols. Track and trace encompass RFID, advance bar codes; hologram labels technology and pedigree protocols.

Although these efforts are part of the solution, they fall short of truly and efficiently solving the problem. The obstacles to quickly adapting them as an effective solution are many. They are costly, time consuming to adopt, have numerous technical challenges, are not standardized and most importantly require each member of the supply chain to be synchronized and monitored for them to be an effective deterrent.

However the biggest drawback is that the only thing that track and trace technologies and protocols adequately track and trace is the packaging that the medication is packaged. Despite all of the cost, technical challenges and time consuming efforts that they entail, these efforts do not authenticate or verify the actual contents which may have been adulterated, counterfeited, diluted or contaminated at one of various points within the supply chain.

Currently XStream Systems, XT250 technology has the ability to quickly, efficiently and effectively authenticate and verify the contents of the medication within the sealed container. This process can happen in a very cost effective manner anywhere within the Pharmaceutical Supply Chain with little or no change in processes or protocols. It can complement existing Track and Trace initiatives by actually providing authentication documentation or operate as a standalone system.

The cost of implementing and operating authentication technology such as the XT250 is a fraction of the initial start up costs of an RFID system and it could be operational in a fraction of the time that it would take for one segment of the Pharmaceutical Supply Chain to implement universally.

Maybe it is just too obvious but I hope that those in a position to make a difference take time to look at filling in the gaps in the current mindset and direction of protecting our Pharmaceutical Supply Chain. Hopefully they discover that the ultimate solution is to authenticate and verify what is in the bottle.

Alan Clock, Senior Vice President, Sales and Marketing, XStream Systems, Inc.

Part 2: Who is liable when a counterfeit or adulterated medication gets to the consumer?

Liability Opinion Series (2 of 4)
by Alan Clock, Senior Vice President, Sales and Marketing
XStream Systems, Inc.

(continued from yesterday)...
If you talk to a wholesaler or a distributor, they tell us they only buy or source product directly from the manufacturer. When applicable because of a state law, then they receive a pedigree. Many feel this protects their inventories and in turn protects them from liability if a product ultimately is found to be adulterated or counterfeited after it winds its way to the consumer. Usually wholesalers and distributors don’t publicly discuss the huge gap of returns and globally sourced products that leave their inventories wide open to a variety of sources beyond their control.

The dispensers, the final piece of the supply chain, tell us that they buy only from the wholesaler or manufacturer and they have contracts with these entities. To dispensers, this means the products from their sources are safe, secure and can be given to patients without worry. It would be naive for anyone that has experience in this industry to think that by the time product is received at the store level, that it is still pristine; especially given the probability that the product could have been touched by nearly a dozen different delivery agents, distributors, couriers or pharmacies by the time it gets to the dispensing location from the manufacturer.

Maybe it’s not so much of a game of “hot potato” but a case of “hear no evil, see no evil, speak no evil”. Meaning that until critical members of the pharmaceutical supply chain have an effective solution or set of tools beyond RFID, bar codes and pedigree to combat issues proactively, they feel like they have to pass the buck or ignore the problem.

Tomorrow I'll address the discussion on pharmaceutical liability at the "SecurePharma 2008" show I attended last week...