Combating counterfeits Flying Null (FN) primarily seeks to assist pharmaceutical brand owners with implementing cost-effective, highly secure and automated anti-counterfeiting measures. According to the World Health Organization, counterfeit drugs account for more than 7% of the global supply of pharmaceuticals and mostly involve tablets and capsules. Some pharmaceutical companies have put this figure at 10% in developed nations and 30% in developing countries.

The FN solution (Figure 1) involves incorporating a ribbon (thread), similar to those found in banknotes, at intervals across the blister pack. It can be transfer printed in certain cases but a 20 mm polyester ribbon with a width of 1 mm is usually employed. This supports an active element, which is a metal alloy (>1 mm thick). However, unlike banknote security, this ribbon contains millions of unique pre-programmed digital identity codes, which are readable from a distance with the appropriate electronic device.

The amount of data, ribbon length and reading range are related but, as an indication, a tag 58 mm long, with 10000000 unique identities, can be read from a range of 20 mm through obstructions such as the metal of the blister pack and outer packaging. Encoding is done securely at the facility and the ribbon cannot be removed from the blister pack without destroying it.

Successful trials of the system in blister packs were recently completed by a major pharmaceutical manufacturer - the first time that this type of device has been successfully incorporated in blister packaging. Brand owners can now implement an advanced authentication solution, linking the code in the ribbon to the barcode and creating a unique encrypted identity for the pack as a whole. Using a handheld scanner, brand owners can ensure that the correct packs are in the correct boxes throughout the supply chain. The scanner has no moving parts, unlike a typical barcode reader, and is easy to use.

Separate trials have shown that such ribbons can also be successfully embedded within the induction seals of pharmaceutical bottles and containers. Conventional RFID uses an expensive microchip and reading problems can arise when the microchip is buried under the aluminium foil of a blister pack. Methods of embedding ribbons include:

• lamination of the thread into plain and fluted cartons, corrugated boards and labels
• lamination of discrete tags into plain and fluted cartons, corrugated boards and labels
• embedding threads during the paper making process
• using a transfer hot foil process.

The ribbon will be useful in identifying pharmaceutical grey markets, which typically employ parallel importing or smuggling. Parallel importing is the unauthorized, but not always criminal, importing of goods for resale, often through conventional sales channels. With pharmaceuticals that may be given away in developing countries but command a high price elsewhere, the pharmaceutical industry has one of the most severe problems of parallel importing - one that can threaten the funding of its research and development and, therefore, its viability.

Previously, there has been little protection against grey markets at the blister pack level. Grey markets in other industries, such as apparel and beverages, have been identified and shut down during the first year of using RFID on products.

Figure 2: A book-type blister pack with an electronic content monitoring system (Information Mediary Inc).

Because this system is more expensive than the ribbon, it will not be deployed in large numbers of blister packs in the near future, but it should prove invaluable in trials to determine the efficacy of new medication and customized blister packs.

The US National Pharmaceutical Council estimates that patients' non-compliance with instructions on medication costs more than $100 billion annually in the US alone, and in 1990 it caused 125000 unnecessary deaths. Indeed, 11% of hospital admissions in the US were also attributed to non-compliance with the instructions on medication. According to Information Mediary, patients taking HIV medication correctly for 94% of the time actually half their chance of suppressing the virus when compared with those taking their medication 100% correctly. This illustrates how even minor mistakes in compliance can distort the results of trials of new formulations and endanger patients taking established medicines.

Variants of Information Mediary's systems can also be used:

• to control unauthorized sales and counterfeiting
• to warn of expiration
• to record data of interest for market research
• to assist in safety studies
• during security investigations.