The three-month study showed that wrongly selected, illegal, expired and counterfeit medicines can be picked up medicines can be identified at the point of dispensing, with minimal interruption of the day-to-day running of the retail pharmacy.
Aegate, a PA Group company that organised the study, said that the technology could be a potent weapon in the fight against medication errors - which cause 11 per cent of hospital admissions in the UK - and medicine fraud, expected to cost a staggering $68bn by 2009, according to market research conducted by Navigant Consulting.
Aegate spokeswoman Alison Williams said that the combination of RFID and bar coding allowed pharmacists an unprecedented level of information about the products they dispensed. The usual EAN bar code on a drug contains nothing more than an identifier, but the system set up by Aegate was able to handle much more information - for example expiry dates, batch number, and even destination data - all linked to a simple RFID code carried in the medicine pack.
Over the course of the pilot, around 180,000 scans were carried out of more than 21,000 individual products.
Pharmacists scanned the items using the laptop-based system designed by Aegate (pictured) and were presented with a visual display of the data held in the system about the product batch, including the expiry date. The ability to pick up expired or short-dated products at a glance was held up as one of the most popular benefits of the technology by the pharmacists.
Other events that occurred during the pilot study reinforced the value of the technology.
For example, counterfeit batches of Eli Lilly's impotence drug Cialis (tadalafil) and Abbott Laboratories' obesity treatment Reductil (sibutramine) were identified, and batch recall notices were issued by the UK Medicine and Healthcare products Regulatory Agency. Aegate was able to use the system to relay this information directly to the pilot pharmacists, and 60 per cent of hem said this was one of the most useful aspects of scanning.
Also, during the pilot the system as challenged with dummy counterfeit packs. 100 per cent of these dummies were stopped. Similarly, in cases where a product was recalled, upon scanning the system locked until a second bar code was run though, bringing the case to the attention of the pharmacist. 11 per cent of the 44 pharmacies included in the pilot received actual recall warnings for drugs, and dummy recalls were picked up with 100 per cent success.
143 safety alerts from the UK Committee on the Safety if Medicines (CSM) were also transmitted to the pharmacists during the pilot, with reference to the CSM guidance displayed each time these items were scanned at the point of dispensing.
Cost and privacy key issues
Williams said that the pilot proved that mass serialisation of medicines - put forward by the US Food and Drug Administration as the single most powerful tool available to secure the drug supply - was technically feasible and reliable.
Issues still remain, however. Cost of implementation is a key factor. Aegate would not comment on how much its bespoke system cost to set up, although Williams cited Aegate chief executive Ian Rhodes, who told a press conference to publicise the results that nationwide implementation would be in the region of a few million pounds, relatively insignificant compared to the total value of the UK pharmaceutical supply chain.
Privacy is another issue, and Aegate has been careful to draw up a code of practice on the use of RFID tags for pharmaceutical products. It is also important that it does not use the Electronic Product Code (EPC) tags, as these could contain info about the patient, said Williams.
For this reason, Aegate was careful to use a simple RFID code number, with all other information linked to it only accessible on the computer system. They also chose the low frequency, 13.5 MHz frequency standard, which seems the most likely to be adopted for package-level tagging. For pallet/case level applications, developers are leaning toward Ultra High Frequency (UHF), but this is not likely to be suitable for package level applications. Not only des its longer range make it unsuitable, but there is some evidence that the heat it generates could affect pack contents.
Aegate is planning additional studies of the system that could look more closely at outcome data - i.e. where a dispensing event may be altered as a result of the technology. It is also exploring the possibility of developing a commercial version of the system, although this could take a year or more, according to Rhodes.