Thursday, June 19, 2008

Track and Trace an Expensive Proposition for Retail Drug Stores

The Coalition of Community Pharmacy Action, which is a group formed by the National Community Pharmacists Association and the National Association of Chain Drug Stores, released a study on June 18th that examined the safety of the prescription drug supply chain and the potential effects of the implementation of a federally mandated track and trace system to protect consumers from counterfeit medications.

Of note, the CCPA estimated in its study that it would cost drug store chains $84,000to $110,000 or more per store in the first year to implement a track and trace system. The cost estimate was based on costs of computer hardware, software, infrastructure, labor and other resources.

Not included in the study was the cost to the other members of the pharmaceutical supply chain; manufacturers and distributors to implement this process. All members of the pharmaceutical supply chain must be involved in the process to make the track and trace process a useful tool in protecting medications.

This is why it important to include an authentication technology either in conjunction with or in lieu of track and trace. An authentication technology, EDXRD verifies the content and make up of the contents of the medication and does not rely on tracking the various stops along the supply chain.


Adam J. Fein said...

I just discovered your blog and am glad to see you highlighting the dangers of counterfeit drugs.

The Accenture study is deeply flawed and says very little about the actual costs of track-and-trace for reasons that I outline on my blog: Accenture's Track-and-Trace Straw Man.

With all due respect to your technology, I can't imagine that pharmacists would want to add yet another authentication step at the point of dispensing. Have you done any research on pharmacist perceptions of your technology?


xstream team said...

XStream's point as it relates to pointing out the many significant issues with Track and Trace are mostly centered on the fact that RFID, pedigree, bar codes or any other Track and Trace technology that seems to be garnering the attention of regulatory and industry experts currently in and of itself are fraught with all sorts of major barriers, including significant expense, to actually becoming a solution to the growing issue of counterfeit, contaminated and adulterated medications.

To your question, XStream's authentication technology is not specifically intended to be used by a pharmacist at the point of dispensing. The XT250 version is intended to be used within the Rx Supply Chain for the authentication of medications within their sealed container. In subsequent versions we will be addressing this more directly.

XStream believes that the authentication of materials within their sealed containers is a much more robust solution to combating the proliferation of counterfeit, adulterated and contaminated medications than by merely tracking or tagging the packaging of the product from production to dispensing.

To date, XSI has had many conversations with large volume dispensers who are very interested in an authentication technology that is used at the point of dispensing. Not only are they looking for protection from counterfeit and adulterated medications but they also view an authentication technology as a way to eliminate medication and dispensing errors. If a technology is capable of doing that, the costs are very relative.

Additionally it is to be noted that an authentication does not require that the entire supply chain bear an expense to make it work. It can be used in a standalone manner, protecting each point in the channel that utilizes its solution.

The Accenture study, as you so correctly point out, seems to be a straw man that can be dismissed as a definitive conclusion as to the expense of the average chain store but it does illuminate the several of the main issues of implementing Track and Trace in the Rx Supply Chain.

A) In order for a Track and Trace solution to work as a viable stand alone solution for counterfeit, contaminated and adulterated medications everyone of the supply chain must synchronized into a system that can accurately track product from the manufacturer to the consumer.

B) A synchronized system will be a significant expense that each member of the supply chain must invest to make this a viable solution.

Troubling to XStream was the statement in the study and press release that counterfeit medications are still a rarity and somehow lessening the importance of combating this issue. This is not a consistent opinion within most honest and informed members within the pharmaceutical supply chain and I am sure would not be supported by the many victims both known and unknown of the recent Heparin adulteration. This is not a stagnant problem nor is it going away. All developed countries are now facing the prospect of a significant percentage of its drug supply at risk due to nefarious force's intent within our global economy.

Although XStream believes that our technology has the capability of rapid deployment and could be used as a standalone solution to the issues of counterfeit, adulterated and contaminated medications, it is our belief that the only long term solution is a hybrid of authentication and track and trace technologies, each maximizing the others' strengths while mitigating unnecessary expense to the entire supply chain.