Positive drug trial verdict

Jonathan Baillie, editor of RFID Solutions, says a pilot in the UK has shown RFID tagging and authenticating of individual medicine packs at point of dispensing has potential benefits for industry and consumers.

A three-month pilot on 'authentication at the point of dispensing', involving 50 UK community pharmacies, dispensing doctors and hospital pharmacies, has confirmed the potential benefits of Radio Frequency Identification (RFID) tagging.The pilot, believed to be a world first, sought to prove that RFID tagging (and barcoding) medical items with a unique serial number can substantially reduce pharmaceutical fraud, minimise dispensing errors and improve patient safety.

project participants

Run from October 2004 until January 2005, the project was led by Aegate, a PA Consulting Group spin-off, established specifically to combat pharmaceutical fraud. Other key participants were:

• BT Auto-ID, which provided the broadband and ISDN connections linking participating pharmacies with Aegate's central database;

• DHL, which distributed 20,000 items of uniquely serialised stock;

• six major drug manufacturers, including Merck Generics UK, Merck Pharmaceuticals (both part of Merck KGaA), Novartis, Schering Healthcare and Solvay Healthcare.

An independent advisory group, consisting of representatives from the National Pharmaceutical Association (which represents around 90% of the UK's 12,500 community pharmacies), the Dispensing Doctors Association and the Royal Pharmaceutical Society of Great Britain, monitored the pilot.

According to Aegate, pharmaceutical fraud now costs the sector an estimated US$30bn globally every year; a figure expected to rise to US$68bn by 2009. 'The problem,' ceo Ian Rhodes explained, 'is exacerbated by criminals increasingly targeting life-saving, rather than, as previously, lifestyle drugs.'

World Health Organisation estimates suggest 5-7% of world medicines may now be counterfeit, while in some less developed nations, the figure may have reached 60%.

Aegate believes mass serialising medical items using RFID and barcodes is a highly effective way to combat this scenario, which Rhodes says has been worsened by the opening up of new borders following last year's enlargement of the EU, and a 'new generation of criminals' targeting the legitimate pharmaceutical supply chain alongside the traditional black market.

The company sees its initiative as an effective way to ensure that pharmacy-dispensed drugs are genuine, and to help minimise dispensing errors in line with the UK's Department of Health (DoH) reduction targets. 'The pilot has proven that scanning serialised products at point of dispensing can not only identify illegal product immediately, but prevent pharmacy staff dispensing wrongly selected, expired or close to expiry drugs,' said Rhodes.

Despite pharmacists' best efforts, Aegate says dispensing errors remain a significant UK issue. According to a Social Market Foundation study, 11% of UK hospital admissions are due to medication errors, while the Medical Defence Union says serious medication errors account for 20% of all NHS clinical negligence litigation.

scanned and dispensed

The mechanics of Aegate's pilot were realtively straightforward. Last autumn each dispensary received an Aegate-developed scanner, which was able to read both linear and two-dimensional barcodes, as well as high-frequency 13.56MHz RFID tags. Each scanner was linked, via dedicated broadband or ISDN line, to a centrally managed database.

Over the three months, 180,000 individual items, ranging from Nurofen packs to needles, were scanned before dispensing; 20,000 incorporated an RFID tag or a secondary barcode alongside the usual EAN barcode.

It typically took less than one second for a tagged product to be scanned, the serialised data to be transmitted to the database and a return message to be displayed on the pharmacy's reader screen to indicate whether the product was genuine. A built-in failsafe required users to acknowledge rejection messages. The innovative scanner/database combination also identified packs at or past their expiry date and goods subject to recent recalls.

'Until last August, the UK had seen no counterfeiting in the legitimate pharma supply chain for 10 years,' added Rhodes. 'However, during August and September counterfeit batches of two drugs, Cialis and Reductil, were identified. Batch recall notices were subsequently issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) and Aegate was able to supply this information to pharmacists who, on scanning any item from an affected batch, were immediately alerted.'

dispensing worries

'Barcodes have been used for years to provide limited pharmaceutical product data, but an existing EAN 13 barcode, for example, does not provide information on expiry dates, while embossed human-readable expiry data can be hard to read. Conversely, the trial's passive RFID tags can generate a wealth of information, from where and when the drug was made to its expiry date. The link between tag and database is immediately established and the pharmacy can receive up-to-the-minute information.'

The system should also reduce the chances of staff picking the wrong item off the shelf. 'All the pilot pharmacists confirmed they worry about making dispensing errors; 70% said the visual display of product details was the most useful aspect,' said Rhodes.

recall information

The system showed another of its advantages by supplying recall notice information on Vioxx and Lorazepam to pharmacists, who were immediately alerted if the products were scanned. Conventionally, regulatory authorities use a paper-based cascade system, but its success depends on documents reaching the pharmacy and actually being read.

In the trial 11% of the dispensaries received recall warnings for Vioxx and Lorazepam, while throughout the 120-day period three groups of test products were recalled on different dates. Each time the system gave the correct response in refusing to authenticate the product.

Aegate acknowledges that drug manufacturers have increasingly turned to devices like holograms to help verify product authenticity, some of which have proven 'quite effective'. However, given criminals' growing expertise in copying such security features, determining which is a genuine hologram and which is a fake is becoming 'increasingly difficult'. Moreover, Rhodes points out: 'some pharmacists may be dispensing hundreds of items a day and simply don't have time to scrutinise every pack.'

commercial advances

Following the trial's success - one in four participating pharmacies asked to keep their scanner - Aegate is looking at building a commercial version and at ways of integrating the existing database system with the NHS patient management record system.

'This process is well aligned with the [UK] government's eHealth agenda,' said Rhodes. 'As the next investments in eHealth technology take effect across the NHS - implementation of broadband and electronic prescriptions - the system's unique elements will create a major advance in patient safety.'

The company concedes that for the health service to derive the maximum benefit, as many pharma manufacturers and pharmacies as possible, alongside key government agencies, must buy in.

Nor is any such system without costs, although it is anticipated that many pharmacies would lease, rather than buy, a scanner. 'Many of the pharmaceutical manufacturers indicated they would be prepared to contribute to getting an authentication system up and running, while we believe pharmacists might happily make a smaller contribution.'

Throughout the pilot, Aegate implemented a code of conduct for RFID tag use. The company was encouraged by the fact that the pilot results suggest that consumers should be 'fairly easy to win over': in a random sample, 95% who recognised or had knowledge of RFID approved of its possible use on pharmaceuticals.

company support

Gaining the support of big pharmaceutical manufacturers will provide the key to wider success. Aegate is currently talking to all major stakeholders, including the DoH, and confidence in the project was expressed in late April when PA Consulting announced that, 'following the outstanding success of Aegate's pilot programme', it will invest £15m over the next 30 months in bringing the 'authentication at the point of dispensing' service to market.

It says this will provide sufficient funding to roll out a commercial service in the UK and to begin developments in other countries.

While admitting it would be hard to force large manufacturers and the community dispensing network to adopt any RFID-based authentication system via legislation, Rhodes expects counterfeiting to become more prevalent in the UK. He believes this, coupled with a growing emphasis on patient safety, could eventually see the system become mandatory, and popular with the big drug companies.