There is much concern that many participants in the pharmaceutical supply chain may not be able to meet this deadline and thus risk non-compliance with the act’s provisions. This pharmaceutical article is excerpts from the Abhisam Software written RFID technology white papers.
Problems with the current pharmaceutical supply chain: The current pharmaceutical supply chain model for the pharmaceutical industry, as it exists today, has two major problems. The first is not about counterfeiting but about diversion. More specifics can be discussed in the accompanying context material and white papers on RFID technologies, but a few highlights are below. To get free information check this link right here now
Diversions of drugs can be of two types. Drugs meant for services such as Medicare or Medicaid, public hospitals or religious organizations are redirected to the private market. Unscrupulous people, without valid licenses, market prescription drugs or “licensed” narcotics to customers. Counterfeiting (by FDA definition) Dummies / Placebos, suggesting that there is no active ingredient in all Products with a smaller volume of active ingredient than specified Products with the wrong active ingredient Products with a packaging that is falsely claimed to have been manufactured by an FDA licensed supplier To offer you an idea of the scale of counterfeiting, only one of these cases includes Other high-value cases include a $200 million nationwide conspiracy for drug diversion, and a $45 million Medicaid fraud involving blood product diversion.
The FDA’s solution to the problem: The FDA ‘s vision of a safe and secure pharmaceutical supply chain is focused on transparency and accountability of all actors in the pharmaceutical supply chain (prescription drugs). The FDA also appointed a task force to research whether this program could be applied with the state of the technologies currently available.
After studying the various technologies currently commercially available that could meet pedigree requirements, including RFID or Radio Frequency Identification technology, they came to this conclusion. RFID appeared to be the most promising among all technologies studied including bar coding and the committee felt that the pedigree requirement could be met by easily leveraging something readily available. (The full RFID technology white paper ‘RFID-FDA-Regulations.pdf’ below provides more details)
How can pharmaceutical companies address this issue: The million-dollar question is “Who can guarantee a ROI on this RFID technology , especially when millions have already been spent?” Even if a full-scale RFID deployment has been completed now, how can it be done quickly, before the deadline of December 2006?
Instead of resisting the implementation of a pedigree system based on RFID systems, participants in the pharmaceutical supply chain must realistically estimate the cost of investing in the technology, the actual cost of counterfeiting, and the returns on a “track and trace” system based on foolproof RFID. The RFID systems will virtually eliminate the pharmaceutical counterfeit market in one go. Second, it can insure that replacements of medications can be rendered quickly without confusion. This has been proven several times. Third, they don’t need to cost the RFID systems too much.
Why monitor and trace can be applied by wholesalers and traders: Ditto for other intermediaries in the pharmaceutical supply chain They can simply join the same global system outlined in the white paper RFID technology currently in place, and easily implement the electronic pedigree system. The only expenditure will be in the Middleware and RFID users. Also those can be bought and introduced by their organizations in bulk at negotiated prices. This also addresses the issue of RFID standards, as all participants would use similar types of RFID readers and RFID applications.