Positive drug trial verdict

A three-month "authentication at the point of dispensing" pilot involving 50 UK community pharmacies, dispensing doctors and hospital pharmacies is believed to be a world first in that for the first time pharmacies and

dispensing doctors were able to obtain up-to-the-minute information on product authenticity at point of dispensing. The pilot sought to prove RFID tagging (and barcoding) medical items with a unique serial number can substantially reduce pharmaceutical fraud, minimise dispensing errors and improve patient safety.

Run from last October until January, the project was led by Aegate, a PA Consulting Group spin-off established in 2004 specifically to combat

pharmaceutical fraud. The other key participants were BT Auto-ID, which provided the broadband and ISDN connections linking participating pharmacies

with Aegate¹s central database; DHL, which distributed 20,000 items of uniquely serialised stock; and six major drug manufacturers including Merck Generics UK, Merck Pharmaceuticals, Novartis, Schering Healthcare and Solvay. An independent advisory group, comprising representatives from the National Pharmaceutical Association (NPA), (which represents around 90% of

the UK¹s 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 $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, counterfeiting may have reached 60%.

Aegate, which funded the trial, believes "mass serialising" medical items using RFID and barcodes is a highly effective way to combat a scenario Rhodes says has been worsened by the opening up of new borders following last year¹s joining of the EU by the Accession States and a "new generation of criminals" targeting the legitimate pharmaceutical supply chain alongside

the traditional "black market".

Genuine drugs and error-free prescribing Aegate sees its initiative both as an effective way to ensure pharmacy-dispensed drugs are genuine, and to help minimise dispensing errors in line with Department of Health reduction targets. Rhodes says: "The pilot has proven that scanning serialised products at point of dispensing can not

only identify illegal product immediately but also prevent pharmacy staff dispensing wrongly selected, expired or close to expiry drugs."

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.

The mechanics of Aegate¹s pilot were straightforward. Last Autumn each dispensary received an Aegate-developed scanner believed to be the world's first able to read both linear and 2-dimensional barcodes and high frequency

13.56 MHz 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 under a second for a tagged product

to be scanned, the serialised data transmitted to the database and a return message displayed on the pharmacy¹s 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.

Rhodes elaborates: "Until last August, the UK had seen no counterfeiting in the legitimate pharma supply chain for 10 years. 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."

Rhodes says: "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. Immediately the link between tag and database is established, the pharmacy receives up-to-the-minute information."

Aegate's 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," says Rhodes. "Indeed 70% said the visual display of product details was the most useful aspect." The system showed another of its advantages when Aegate was able to supply recall notice information on two specific drugs, Vioxx and Lorazepam, to pharmacists, who immediately picked up on this information if the products were scanned. Conventionally, regulatory authorities typically use a

paper-based "cascade" system, but its success depends on documents actually reaching the pharmacy, being read and action being taken.

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. Every time the system gave the correct

response in refusing to authenticate the product.

Aegate acknowledges drug manufacturers have increasingly turned to devices like holograms to help verify product authenticity, some of which it

concedes have proven "quite effective". However, given criminals' growing expertise in copying such security features, determining which is a genuine hologram and which 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."

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 how to integrate the existing database system with the NHS patient

management record system. Rhodes says: "This process is well aligned with the government's eHealth agenda. 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."

Manufacturers must "buy in" Aegate concedes that for the health service to derive the maximum benefit, as many pharmceutical manufacturers and pharmacies as possible, alongside key government agencies, must "buy in". Nor is any such system without costs, although Aegate anticipates many pharmacies would lease, rather than buy, a scanner. Rhodes also says that "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. However, it was encouraged that the pilot results suggest 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.

Gaining the support of big pharmaceutical manufacturers will be key to wider success. Aegate is currently talking to all major stakeholders, including the Department of Health, with a view to progressing the project but says

it will take a year to perfect the reader and develop the software to enable it to integrate seamlessly both with the pharmacists' Patient Medication Record systems and the new N3 NHS IT system. However, confidence in the project was expressed in late April when PA Consulting announced that, "following the outstanding success of Aegate¹s 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 Aegate's commercial service in the UK, and to "begin

developments" in other countries.

The reception to the system from one key pilot participant, Solvay Healthcare, backed Ian Rhodes' optimism that the authentication system will not only work effectively in the real-world, but that pharma companies and pharmacists will soon "come to accept it as a part of everyday life". Solvay ceo John Peter says: "The Aegate trial has demonstrated that, if we were to

implement unique identification tagging, pharmacists would welcome it and it

would protect the authenticity of our products. We believe this pilot has identified many opportunities to increase patient safety."

While admitting it would be hard "to force large manufacturers and the UK's entire community dispensing network to adopt any RFID-based authentication system via legislation, Rhodes says Aegate, sadly, expects counterfeiting to

become a more prevalent future UK issue. He believes this, coupled with a growing emphasis on patient safety, could eventually see such a system

become not only mandatory, but equally popular with the big manufacturers.