Medical Device Link.

SECURITY PACKAGING SUPPLEMENT

Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry. The World Health Organization (Geneva) estimates that global sales of counterfeit and substandard medicines garner more than $32 billion annually.

Both drugs and drug packaging have been counterfeited and have put lives at risk. In addition, fraudulent diversion of legitimate product outside of authorized distribution channels poses problems.

Many of the world’s leading pharmaceutical companies have aimed to authenticate their packaging as a step to protecting their products. Diffractive optically variable devices—referred to generically as holograms—have become one of the most widely used overt authentication features on pharmaceutical products around the world.

The industry has adopted holograms since GlaxoSmithKline first used a tamper-evident hologram to seal packs of Zantac in 1989. Many major drug companies use holograms on at least some of their medicines in selected markets in the form of labels, seals, hot-stamped patches, and blister foils.

Continual innovation, invention, and evolution in holographic techniques enable holograms to provide effective protection. These advances also have succeeded in creating increasingly complex devices that are easily recognized yet difficult to copy accurately.

Hologram technology has evolved with the increased combination of the security device and other authentication technologies. In such solutions, holograms often provide overt first-line authentication, while covert features—scrambled images, microtext, or UV-sensitive or other specialist inks—provide second-line authentication for trained examiners equipped with appropriate decoding equipment.

Another trend is the serialization of holograms as part of systems that combine authentication with traceability. Track-and-trace systems link on-pack security devices with database management and field-tracking services. In this way, the ability to know where a pharmaceutical’s consignment has been, where it is now, and where it is heading has become a fundamental part of many drugs companies’ production and logistics operations. This is particularly important—the ability to identify the source and provenance of products is becoming a mandatory requirement, as with for FDA and some states.

While the U.S. Congress considers mandating the use of security marking on some pharmaceutical products by using “overt optically variable counterfeit-resistant technologies” to protect consumers from fakes, the hologram already acts as the authentication feature on the world’s only mandatory scheme for the authentication marking of registered pharmaceuticals: the Meditag program in Malaysia.¹

This initiative requires all registered medicines, OTC pharmaceuticals, and traditional medicines to carry a uniquely numbered label built around a hologram. A central authority supervises the system, controls the issue of tags, and trains inspectors to examine holograms through the distribution chain.

Since its introduction, this system has led to a significant increase in the identification and confiscation of illegal items from the market and prevented their entry into distribution channels. As a result, consumer confidence in the integrity of pharmaceuticals has increased and public health has been safeguarded.

Nigeria’s National Agency for Food & Drug Administration and Control an­nounced plans to introduce uniquely numbered holographic labels on all licensed medicines distributed in the country.

Perhaps unsurprisingly, the success and near-ubiquitous use of holograms in anticounterfeiting applications has led to attempts to copy or replicate them. The intrinsic features of holograms, however, mean that the techniques and visual effects make it very difficult to copy a properly conceived and executed authentication hologram with 100% accuracy.

Holograms have succeeded in their job. They have proven to be extremely difficult to copy accurately. While the product and packaging they protect might have been counterfeited, the lower-quality copy of the hologram has often been the feature that has revealed its counterfeit status.

In this way, the hologram serves as an effective detection feature. Although sophisticated criminals have the resources to reproduce packaging that is barely distinguishable from the genuine, the same cannot be said of fake holograms. Artesunate, an important antimalarial treatment, is one example of how not to manage a hologram authentication program on a medicine brand. Reportedly, over half of this drug’s sales in Southeast Asia are fake, despite the blister pack incorporating a hologram.

Despite the fact that the hologram used is relatively simple and has been un­changed for several years, the fake holograms are identifiable as such. The problem is that in a region of low rural literacy, high poverty, and poor drug regulation, where medicines are sold in street markets and nonspecialist shops, most buyers and users of Artesunate see a hologram and think that means the medicine is genuine. The hologram has not been redesigned since its introduction, and insufficient attention was paid to the distribution, examination, and purchasing patterns in the region.

Formal inspection of the hologram provides the quickest way to identify a fake product, even if that further needs to be supported by forensic examination. It should not be the sole responsibility of the consumer to examine a hologram to check that the product is genuine. Successful brand protection programs now involve formal examination and inspection systems at different stages in the distribution network.

The holographic industry is working hard to destroy the myth that sophisticated holograms cannot be counterfeited. Anything can be counterfeited; the question is how well. Herein lies the real value of holograms.

¹Ian Lancaster, Editorial Director of Authentication News, director of the Global Forum on Pharmaceutical AntiCounterfeiting, consultant to Malaysian Ministry of Health and the National Agency for Food & Drug Administration and Control, Nigeria.