Combating pharmaceutical fraud

	Pharmacists and companies can use this mechanism to check medicines are authentic

Fraudulent drug products in the supply chain cost pharmaceutical companies millions in lost revenues and damage to their brands. It is about time the industry began tightening up its counterfeiting measures, says Alison Williams, head of marketing for drug authentication company Aegate.

Pharmaceutical companies are losing an estimated $30bn per year as a result of fraud. Included in this figure are diverted products as well as stolen and counterfeit medicines. The World Health Organisation estimates the prevalence of counterfeit medicines to be in the region of 8-10 per cent. This has a direct impact on the bottom line from lost sales, brand damage and expensive litigation.

Security and patient safety

Why are existing security devices not effective? Holograms, colour change inks and other overt or covert devices added to packs are extremely useful for forensic analysis following a suspected incident. However, given the lack of standardisation and the number of different packs, there is no simple or reliable way for these to be proactively checked before dispensing. Importantly, many of these devices are copied within a matter of months.

In the USA, guidance put forward by the FDA through the use of mass serialisation and the creation of electronic pedigrees to tighten the supply chain and track products from the manufacturing site to the point of receipt at the dispensary, is slowly being adopted.

Mass serialisation is a method by which items are assigned a unique identifier, rather like a serial number on a domestic appliance. So far, tests have used this methodology to enable products at pallet level to be tracked through the supply chain, for instance, the unique identifier is checked each time the shipment changes hands. For inventory control purposes this is extremely useful.

However, when it comes to patient safety, Aegate's Authentication at the Point of Dispensing(tm), successfully tested in 2005, provides a real-time confirmation of authenticity at the start and end of the supply chain - the manufacturer and the pharmacist. Authentication at the Point of Dispensing opens up a new communication channel between the manufacturer and the pharmacist for patient safety messages to be relayed, such as recalls, expired, illegal, stolen or counterfeit medicines.

This approach makes use of mass serialisation technologies at the unit-of-use level and reports back via an electronic feedback loop to manufacturers that the item was authenticated. The choices of technologies that can be applied are broad, from a simple printed bar code to a more expensive RFID tag. The manufacturer's selection of technology is likely to be made on a product basis, evaluated on cost vs benefit vs level of security required. It appears that the most pragmatic approach in the short term is to use bar codes unless the product is at significant risk from counterfeiting.

In contrast, electronic pedigree (e.pedigree) software is not a live check and relies on each trading party to have and use compatible software so that the pedigree is not broken in transit. This may ultimately protect wholesalers and traders in the supply chain, but does little more than adds to the manufacturer's costs without significant benefit. E.pedigree currently relies on the application of an EPC RFID tag, which is more appropriate for pallet-level application rather than unit of use.

Given that medicines can change ownership as much as 20 times between the point of manufacture and the pharmacy, e.pedigree is a long-term vision. Current estimates suggest that full implementation is 5-10 years away.

One-stop security

Authentication at the Point of Dispensing is a globally applicable solution that does not rely on every part of the supply chain to comply. It provides a secure and important feedback loop that confirms that the product that reaches the patient is still as intended when it left the factory gates. Aegate's authentication service will be available in 2006.

Company

For pharmaceutical companies that have added mass serialisation security technologies to their medicines, Aegate will be able to relay important safety messages to pharmacies, alert companies if illegal medicines are detected and confirm that the medicines they have supplied have been authenticated. For more information, visit: www.aegate.com

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