The Pharmaceutical Journal
Vol 277 No 7417 p317
9 September 2006

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Radio-frequency ID to the rescue

Peter Harrop outlines moves towards introducing radio frequency identification as a means of verifying the authenticity and integrity of medicines, as well as to improve compliance and reduce medical errors

The past year has seen the first major drug trials to use radio-frequency identification-enabled blister packs to record which tablet was taken and when. Some display this information so that patients can try to improve compliance and they have welcomed this.

Half of all patients take medicines incorrectly and hospitals make errors too. This depresses both the number of successful outcomes and sales of pharmaceuticals. Plus, there is the well known problem that premature ending of antibiotic treatment increases drug resistance.

In the US, a National Institutes of Health trial of azithromycin and a recent Novartis trial are among those that have used this improved form of data capture.

In the UK and the US alike, there is concern at the entry of counterfeits into the legitimate drug supply chain. Instead of coming up with yet another feature that is difficult to copy, the US is adopting a similar approach that that used to identify counterfeit art works by combining chemical analysis with verified records of the origin and ownership through life. Americans call this pedigree and Europeans call it provenance. In the case of medicines, the process employs secure databases storing both the destination and history of each pack of drugs captured via unique electronic identification in a process called mass serialisation.

Encouraged by the Food and Drug Administration, various US deliveries of drugs have had unique electronic identification provided by RFID labels at item level. Pfizer’s Viagra, GlaxoSmithKline’s Trizivir and Purdue Pharma’s Oxycontin are examples.

Machine readable unique identity can be provided by two-dimensional barcodes, such as DataMatrix or by RFID. In the US, the work mainly involves RFID because the FDA and organisations it consulted consider that RFID gives the most accurate and rapid result. There is some joint usage with 2D barcodes, when the blister strips are barcoded to save cost and the pack of blister strips is RFID tagged. Currently, 60 companies are working on printing electronic circuits, such as RFID circuits, directly on to products in the way that 85 per cent of barcodes are applied today in order to eliminate the most expensive part of RFID tags — the silicon chip.

Over one billion high frequency (13.56 MHz) RFID tags have been used over the years. This makes it the most proven RFID frequency. On medicines, only HF label systems currently give a guaranteed 99.95 per cent read, with no ghost reads and the smallest labels. About 20 million will have been applied to prescription medicines in the US by the end of the year. However, because Wal-Mart uses UHF RFID on pallets and cases it requires UHF RFID on item level medicines as well. These are completely different tags and require different readers. Wal-Mart has also demanded that addictive drugs be RFID tagged and, with some pharmaceutical companies also liking UHF, there may be 10 million UHF tagged packs passing through the system this year as well.

Unfortunately, unlike HF, UHF RFID is unlikely to receive radio regulations approval for the same power level, bandwidth, signalling protocol or even frequency, worldwide, although there are strong moves to make it legal globally.

The FDA is impatient, because it sees counterfeiting imperilling public safety and striking at the heart of the industry. It believes that RFID is the best defence and is expected to introduce requirements, but there needs to be a decision on frequency and further clarification on what is to be kept in any secure database and who will have access to it.

In Europe, the European Federation of Pharmaceutical Industries and Associations has declared RFID to be too expensive until at least 2010, and has advocated mass serialisation using 2D barcodes in the meantime. With no European equivalent to the US FDA, it remains to be seen whether the various European regulatory authorities will take a stronger view. Certainly there are many trials of RFID on drugs for anti-counterfeiting in Europe.

The situation has been further confused by the leading suppliers of UHF RFID labels now advocating a variant that is currently unproven in large scale use. This so-called near field UHF could lead to reduced label cost and even reduced cost of ownership of the system; it also avoids the problems nearby water and metals cause for standard UHF systems. However, it does require different antennae in both tag and interrogator.

One thing is sure, the problems in the pharmaceutical industry are too urgent for much delay to be tolerated. RFID speeds stocktaking in the pharmacy and improves supply chain efficiency. It is almost a case of any decision being better than none as we wrestle with whether to use HF RFID or near field UHF RFID.

The International Society for Blood Transfusion is developing an RFID labelling standard for use on blood bags and which is expected to be extended to other blood products. Working party member Clive Hohberger, formerly of Abbott Laboratories, says: “Because blood is a prescribed product, we are developing the standard around high frequency RFID and plan to use the same HF tag that EPCglobal — the organisation that leads the development of industry-driven standards for electronic product codes to support the use of RFID — is specifying for use and which will be used heavily in the pharmaceutical industry.”