Hospital Pharmacist
2007;14:25
January 2007

American Society of Health-System Pharmacists

Using technology to combat fraud

Despite enforcement efforts, substandard, counterfeit drugs continue to plague the drug supply chain, according to Marvin Shepherd, director, Centre for Pharmacoeconomic Studies, University of Texas, US. Dr Shepherd, who received an award of excellence from the American Society of Health-System Pharmacists for his leadership role in protecting the American public from counterfeit, diverted and substandard medicines, described several techniques that are available for product authentication. These include encrypted serial numbers for each package which can be validated by the manufacturer, overt labelling technologies such holograms, colour shifting ink or raised print, forensic techniques using taggants (minute quantities of inert, easily identifiable additives) and a variety of covert methods such as invisible inks, micro-magnetic wires and computer chips (radio frequency identification — RFID).

The World Health Organization has estimated that counterfeit drugs comprise 1–10 per cent of the world market, depending on the country and region. In developed countries, WHO estimates the figure to be less than 1 per cent, but this figure rises to 10 per cent in some developing countries and 30 per cent in Africa, parts of Asia and Latin America.

RFID

The driving force behind the move towards RFID is the Food and Drug Administration’s demand for a drug pedigree system, preferably electronic, by 2007. The overall goal is to develop a system to protect the public and ensure product integrity. It is recommended that each package should have a unique serial number. Serialisation is the foundation of the system and it can be used with either bar coding or RFID. Basically, each package will have a unique “licence plate number” and this will enable it to be tracked and traced through the whole supply chain from manufacture to administration.

Dr Shepherd pointed out that RFID is not new. It was used by the British in the Second World War to identify aircraft, and patented in 1973. However, following recent technological advances, RFID use has grown tremendously and it is now in place in many areas including toll roads, livestock management and luggage labelling. In health care, it is being used for patient, medicines and staff identification, tagging high cost medical devices, and surgical swab reconciliation.

RFID systems are made up of a number of components: static or handheld readers that transmit and receive data, antennae fixed to readers and tags (transponders), tags that are attached to items or people, system software, computers linked to readers and Windows operating systems that link serial numbers to databases.

As expected, global standards have been developed for RFID tags and the latest release appeared in 2006. These have been developed by EPCglobal, a non-profit making company. The standards define interface specifications, formats for data on the tags and communication protocols. An electronic product code (EPC) is assigned by EPCglobal from its object naming registry. The tags can be encoded with nearly any internationally recognised coding system and the data will include the manufacturer’s identification, global trade number and package serial number.

Part of the unique serial number of the tag is burned on to the chip by the chip manufacturer. The drug manufacturer then adds the EPC to the tag. Although the counterfeiter may be able to use the EPC, the chip number is unique and the counterfeit product will therefore be easy to detect.

RFID readers and tags use different radio frequencies. Dr Shepherd explained that as the frequency increases, the ability of the wave to penetrate through different materials decreases. Ultra high frequency tags have a long range and are good for scanning cases, pallets and large boxes, and low frequency tags with a short range are usually attached to individual packs.

Advantages of RFID include improved tracking, combating counterfeiting, reducing medication errors and simplifying recalls. Pallets do not have to be disassembled for checking and label orientation is not necessary — a great advantage for pharmacy automation. Most of the major pharmaceutical companies have tested the system and many will be rolling out this technology in the next year or two.

Bar codes

The FDA rule requiring drug manufacturers to use bar codes on medicines is slowly being adopted. It can cost hospitals $400,000 to $2m to introduce the technology and even then, the system will not be complete because some manufacturers are still not printing bar codes on their products.

Currently, it is estimated that only 10-20 per cent of hospitals are using bar codes at the point of care. According to Dr Shepherd, hospitals that have employed patient-level and medication-level bar codes have reduced their medication error rates by over 80 per cent. However, he added, bar codes have major limitations. Each item needs to be scanned and a “line of sight” is required. This increases the time required for each operation in the distribution process and therefore has a high end-user cost compared with RFID. Bar codes can also be copied and attached to other containers, making it more difficult to detect counterfeits. They may also get dirty, tear or suffer from moisture damage, all of which may cause readability problems. Despite these limitations, bar codes are highly reliable and they will not disappear in the near future. It is likely that they will be used as a backup in conjunction with RFID systems.