George's Corner: July/August 2013

Track and Trace and Fail

The editors of ComputerTalk asked me to take a look at track and trace. I said OK, partly because the California State Board of Pharmacy’s e-pedigree committee had scheduled a meeting about it, and that would give me a chance to see some old friends and maybe even offer an observation or two.

I haven’t been closely following this for a few years, so I had to refresh myself on the subject. In the early 2000s there was a lot of noise about counterfeit drugs. Newspapers, TV, and radio were all hollering about how we did not know if the drugs we were getting were real or not. The federal and state legislatures, of course, wrote laws. (That’s the way they respond to any crisis.) Speeches were given, meetings were held. Lots of folks had many ideas about how to solve the problem. (Most of the ideas were ideas that made money for the proposer of the idea.) Remember the talk and some expensive false starts with RFID? It is good that one fell by the wayside. It was expensive and unwieldy, and used unproven technology that the proposers wanted to sell to everyone in the drug distribution system.

Somewhere along the way it was decided that the method to deal with this would be to keep track of every container of drugs. The system would know where it was at any given time and when and where it had been throughout its existence. Everyone who’d taken possession of it would have to report receiving it and where it went when it left that possession. Track and trace.

Of course, the packages that were tracked and traced were all put into the system by legitimate manufacturers, and anything not in the system would be deemed illegitimate. Problem solved.

This is being written after attending an all-day meeting in June (about 50 people, all with skin in the game) of the California State Board of Pharmacy e-pedigree committee. 

California’s board has had to take the lead on this issue because the California legislation says that the problem must be solved and the solution implemented by a certain date. The first big deadline is Jan. 1, 2015. Congress’s legislation does not have any deadlines. It just tells the FDA to fix it. Both seem to favor the track-and-trace solution. Many in California have hoped that the FDA would do it, and California could help them put it together and join in a national solution. But California has to obey its laws, so it has been working diligently on the issue. (Today’s meeting was attended by a lot of expensive people from throughout the United States because, given the above, California cannot be ignored.)

Figuring It Out 

I listened to several presentations about how it could be done, what the components would be, and how each package’s pedigree would be passed on to each possessor of the package. In a side conversation one attendee said to me that it was a huge paperwork system and the only saving grace would be that it would only consume electrons, not paper.

I listened to several presentations about how it could be done, what the components would be, and how each package’s pedigree would be passed on to each possessor of the package. In a side conversation one attendee said to me that it was a huge paperwork system and the only saving grace would be that it would only consume electrons, not paper.
The first presentation was by someone from Turkey, who spoke to the group on a Skype-type hookup. He told us how Turkey’s track-and-trace system worked, and some of the issues they dealt with during implementation. The main point I got out of his presentation is that this is an international issue that needs an international solution, not a California solution.
A couple of presenters pointed out that counterfeit products could be put into the system at the wholesale or retail level without being detected by the system. At that point I said to myself, wait a minute, I thought that was the objective of all of this work, to keep counterfeits out of the system. I also remembered one of the first meetings at which someone said that the solution is simple: Barcode a unique number on each package. So how would this work? Short version: Every dispensing would require that the package’s unique barcode be sent to a central database. (Most would be a branch off the claims processing system.) The code is unique, so any repeat of that code means that someone has copied the code. This would be fraud. If the counterfeit code is a unique code created by the counterfeiter, it will not be found in the database of codes provided by the legitimate manufacturers. The central database would “authenticate” by checking to see if that unique code had already been sent by another pharmacy or too many times by that pharmacy. (Too many times would be something like eight prescriptions for 100 tablets dispensed out of a 500 tablet bottle.) If either thing happens, counterfeiting is suspected, a flag goes up, and appropriate action is initiated.
By the way, that unique number can easily include the NDC number for the drug, the lot number, and the expiration date. So the same barcode can be used for billing and claims processing and for checking stock for expiration dates.
Although I wasn’t on the agenda, I asked to speak during the afternoon session.
I believe I made the shortest presentation of the day. I pointed out that the original objective was to stop counterfeits. That track and trace does not do that. That there is a simple solution — authentication — which does stop counterfeits and that once this is understood by all the players a system that does the job can be implemented.
The meeting then returned to picking over the minutia of track and trace’s complicated implementation.
However, I was pleased to find that a number of the attendees agreed with my observations and thanked me for sharing them.
I know that the solution I presented has its own issues and needs a complete workup so that they are all dealt with before implementation. I also believe that its issues can be solved rather easily, and a much less costly development, implementation, and operation would result. Most importantly, it will deal effectively with the primary objective.
Track and trace fails. CT 

George Pennebaker, Pharm.D., is a consultant and past president of the California Pharmacists Association. He can be reached by email at george.pennebaker@sbcglobal.net


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