The idea is that RFID will reduce the labour-intensive process of tracking the supply of sensitive drugs mandated by the US Food and Drug Administration, which requires each dose to be accounted for. But are current RFID labelling technologies truly up to the job, asks Phil Taylor?
One company which specialises in the supply of printed labels to the drug industry is not so sure.
George Schmitt & Co claims to have developed a proprietary validation technology which means it can guarantee 100 per cent that each label coming off its production line carries a 'live' tag with the correct Electronic Product Code and National Drug Code. But from an industry-wide perspective, this may not be the case, according to the company's president Bill Gunther.
He estimates that the proportion of faulty tags supplied by any tag manufacturer can vary from single digits to the high teens in percentage terms. This puts the onus on the printer/labeller to make sure that these dead tags do not end up in the end product, but also to ensure that the information contained in the tag corresponds to what is in the pack.
But Gunther has been startled at the level of acceptance of faulty tags and the acceptance that a certain proportion will be unreadable.
"I am very, very uncomfortable with the general industry mind set that anything less than 100 per cent accuracy is acceptable," he told In-Pharmatechnologist.com.
Any drug company trying to comply with the Wal-Mart initiative - or indeed pursuing RFID on its own - should be asking some tough questions, according to Gunther. It is important to know what percentage of tags a supplier expects will be non-readable arriving at your facility, the process that the supplier will use to support that expectation and whether it is guaranteed that all arriving tags contain EPCs that correspond to the printed label graphics.
George Schmitt claims to have solved these problems using a combination software/hardware package that uses multiple RFID reading devices and a proprietary shielding technology that fulfils Wal-Mart's objective of discriminating a single 900 MHz tag, from a range of more than 24 inches, even if it is in close proximity with a range of other products.
The system also includes a sequential electronic database that records and tracks each tag along with the product EPC and NDC. "Nobody else is doing this," said Gunther.
The big question is, what level of reliability will be acceptable to the drug industry? A straw poll of drug companies conducted by In-Pharmatechnologist.com failed to gather a clear consensus on the issue, at least for the application of RFID at the pallet or case level. But this reticence related mainly to the fact that the feasibility studies of the technology are in many cases still ongoing.
Pfizer, the world's number one pharmaceutical company, is among a number of drugmakers, distributors and pharmacy chains taking part in a project organised by Accenture to explore how RFID will work in practice in the drug industry - and identify whether the technology is robust enough for medicines supply.
There was unanimity on one point, however. Should the tags eventually be used as expected to guide delivery of drugs to the patient, anything less than 100 percent accuracy will clearly be unacceptable. And most felt that it was almost certain that the technology would be a powerful means of protecting against drug counterfeiting and diversion.
One concern voiced by industry related to the US Food and Drug Administration and other regulators' current Good Manufacturing Practice (cGMP) rules that require the validation of computer systems to assure the accuracy and integrity of data. It is not clear how RFID systems, which are integrated with computers, can be validated so that government regulators are sure the right tag was read and not a nearby tag.
In addition, questions were raised about confidentiality (i.e. will one company be able to get information on what products another is shipping), how to ensure that tags themselves cannot be counterfeited, how to handle the vast increase in data that will have to be managed, and of course the cost of the tags.
On the latter point, a recent report from Paris-based consultancy Cap Gemini Ernst & Young concluded that this is not as big an issue for the pharmaceutical companies as it is for consumer packaged goods companies. That is because the value of pharmaceuticals is much higher and also because drugmakers can ask distributors to deploy and absorb the cost of the tags.
In-Pharmatechnologist.com and sister site FoodProductionDaily.com have put together a feature that examines the impact of RFID on the pharma and food industries. For instant navigation, follow the links below.