I've been doing some research on RFID and drug counterfeiting for a term paper; cool technology and very interesting topic. I can see how the idea of an e-pedigree / track & trace can add additional security to the "approved" drug supply chain. By "approved" I mean within the manufacters, distributors, and pharmacies that have the right intentions.
However, what about the pharmacist who has a private stock of counterfeit drugs that he intentionally received from channels outside of the "approved" drug supply chain. Aren't most of these covert counterfeit networks always going to operate out of the "approved" channels and therefore bypass all RFID / e-pedigree / trace & trace checks?
I reference an article from Pharmamanufacturing below for some examples ...
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http://www.pharmamanufacturing.com/articles/2006/080.html
... In the spirit of sharing information on how best to combat the spread of counterfeit drugs, Moore detailed three cases in which Merck and authorities had foiled the bad guys:
1. U.S./Mexico Border: A U.S. citizen traveled to the border region and purchased what he thought was Zocor, Merck’s cholesterol-lowering drug. When the patient’s subsequent blood tests showed cholesterol levels double what they should have been, he notified the company.
Merck sent undercover professionals to the pharmacy. The first, who spoke Spanish and portrayed himself as Mexican, was turned away. A second, an English-speaking “American,” was sold the product from a private stock behind the pharmacy. The tablets turned out to have no API in them.
2. Chiclayo, Peru: Merck and police received reports of bogus Fosamax, a medication to enhance bone density, at a Peruvian pharmacy. A first raid on the pharmacy resulted in the seizure of one ton of counterfeit product. A second raid on the home of the pharmacist recovered 12,000 tablets, as well as fake labels and blister packs — the equivalent of one month’s sales of Fosamax in Peru, Moore noted.
3. Germany: Counterfeit products (ostensibly from Merck and other large manufacturers) were being produced in China, shipped through the Balkans, and sold in the European market. Large amounts of fake Propecia and other counterfeits were seized in Germany.
Over 400 interrelated web sites had coordinated to market the counterfeit products, Moore said. The mastermind behind the scam was a former physician from New York.
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I think the presumption is that RFID should be able to stop or throw a "flag" to prevent the counterfiet drug from reaching the consumer. But how does it stop the pharmacist that's part of the counterfeit ring / counterfeit supply network, like in examples 1 and 2 above? Unless the customer (who does have the right intentions) is the one doing the authentication check and filling the Rx, can't the "shady pharmacist" always swap in the counterfeit drug? Rx drugs are dispensed behind a counter and then provided to the customer by the pharmacist ... the pharmacist has the final control. It's not like a set of counterfeit golf clubs from China sitting on the show room floor that the customer purchases and walks out the door with.
Does anyone know of any research out there that takes a look at more of the specifics of how counterfeit drug rings operate? I've seen a lot of high-level statistics that reference the increase of drug counterfeiting (collected by FDA, WHO, etc.) but I was just wondering if anyone has done an analysis of actual counterfeit drug cases to identify exactly where the counterfeit drugs entered the supply chain and then to try to correlate that with what is being proposed that RFID/e-pedigree/track-and-trace will solve. I can see where the technology will absolutely help tighten the "approved" drug supply channels but if the counterfeit drugs are entering the supply network via other mechanisms, then the new technology might not actually solve the real problem. It would be interesting to see what percentage of these actual drug counterfeit cases the proposed solutions might actually prevent. Is it 90%, 75%, 50%, 25% .... ?
I guess I've seen a lot of research on the solutions to "the problem" but very little research on identifying and characterizing the problem itself. Perhaps I should be looking in other journals besides technology journals for that though.
Any feedback would be greatly appreciated. Thanks!