A pharmaceutical RFID and bar code pilot underway in the U.K. aims to detect dispensing errors and counterfeit drugs before they reach patients but without tracking items as they move through the pharmaceutical supply chain.
The “authentication at the point of dispensing” pilot has been organized by start-up Aegate and brings together six U.K. pharmaceutical companies—including Merck Generics U.K., Merck Pharmaceuticals, Novartis, Schering Health Care and Solvay—and 50 dispensing outlets, which include hospitals and small pharmacies across England. Aegate says its trial is targeted only at providing pharmacists and doctors with information in a pragmatic way to authenticate products at the point of dispensing.
“There has been a lot of interest in RFID for track and trace in the pharmaceutical supply chain focused on increasing efficiency, but the focus of this pilot is patient safety,” says Ian Rhodes, CEO at Aegate, which is based in Cambridge U.K.
Aegate believes that trying to implement track and trace in the pharmaceutical supply chain would be an unnecessarily complicated and unwieldy solution that would hamper much of the business of supplying drugs across Europe. “When these highly regulated products leave the front gate of the manufacturer, they go into a very complex supply chain. These are high-value, easy-to-transport items with a long shelf life, so they can become commodities traded up to 30 times before reaching the dispensing pharmacist. We want to find a way to protect patients without standing in the way of that free market,” says Rhodes.
During the three-month pilot, which started in October, the pharmaceutical companies involved in the pilot will tag between 20,000 to 30,000 from a total of 12 different branded and non-branded pharmaceutical products. The RFID tags will be placed on the inside of the cardboard packaging of items in a range of formats, including blister packs, bottles, canisters and aerosols.
The pilot is using read-only 13.56 MHz tags from Rafsec that conform to the ISO15693. RFID tags are being used along with a range of bar code technologies. According to Aegate, while RFID will be one way of authenticating individual items with a unique ID number, EAN 128, Datamatrix 2D and RSS 14 bar codes will also be used in the trial to label an additional quantity of items. Aegate maintains that some pharmaceutical companies may opt to not trial RFID for some of their products—such generic drugs—because the higher cost of RFID tags could have too great an impact on the profit margins on those products.
“We are using a range of mass-serialization [numbering] techniques in the pilot,” says Rhodes, adding that RFID can increase the level of counterfeit protection by pushing up the cost of counterfeiting. According to Aegate, a counterfeiter can easily and cheaply copy a printed bar code. Copying holograms is also relatively cheap and easy; some holograms have been copied within three months of being put on a pack. An RFID tag diminishes an item’s attractiveness to a counterfeiter because the cost of creating a counterfeit copy of an RFID tag is higher and harder. For many items, however, the technology will be too expensive for some pharmaceutical companies to deploy. Nonetheless, among the technologies being used in the pilot, RFID uniquely enables pharmacists to read an ID number of products sealed inside a carton without needing to remove the contents of that carton. This makes its easier and quicker for pharmacists to inventory and dispense items.
According to Aegate, the pilot is not about proving the technology involved but testing how the scanning of products can be incorporated into the dispensing process. During the pilot, each pharmaceutical item’s RFID tag or bar-coded label will be scanned by the manufacturer before entering the supply chain, and the unique serial number on the tag or printed bar code will be linked that item’s product data, including such things as the item’s expiration date, and stored in a database managed by Aegate.
The item is scanned again prior to being handed to a patient by the pharmacist using multiprotocol scanner. Deployed at the pharmacy by Aegate, the multiprotocol scanner not only can read an item’s RFID tag but also its printed bar code, regardless of which of the three formats the bar code uses (EAN 128, Datamatrix 2D or RSS 14).
Each scanner uses a broadband network connection, supplied by U.K. telecom carrier BT as part of the trial, to communicate with a central database managed by Aegate that will enable pharmacists to confirm they using genuine product as well as that it is the correctly product, that it has not past its expiration date and is not subject a recall.
According to Aegate, there is a significant need for a system to counteract both counterfeit and incorrectly dispensed drugs. “In the U.K. it is estimated that around 11 percent of hospital admissions are the result of either prescription or dispensing errors, and those errors result in an average hospital stay of seven days,” says Rhodes.
Interest in the RFID technology from the pilot’s dispensing outlets has heightened recently because of a recall of two drugs in the past six weeks—the first drug recall in the U.K. since 1994. The drugs have been recalled by the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) because of counterfeits in the U.K. supply chain.
An independent advisory group is overseeing the pilot, made up of pilot participants and representatives from three U.K.-based organizations: the National Pharmaceutical Association (NPA), the Dispensing Doctors Association (DDA) and the Royal Pharmaceutical Society of Great Britain (RPSGB).
Aegate expects to publish the results of the pilot in late January and, depending on the results, plans to commercially offer the database management service to pharmaceutical companies and dispensing outlets.