Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry. The World Health Organization estimates that annual earnings from the global sales of counterfeit and substandard medicines exceed $32 billion. Drugs and packaging are both counterfeited, putting people's lives at risk. Diversion of legitimate product outside authorized distribution channels is another problem. In response to this problem, many pharmaceutical companies authenticate their packaging to protecting their products. As a result, diffractive optically variable devices--referred to generically as holograms-are used as overt authentication features on pharmaceutical packages around the world.
Since Glaxo first used a tamper-evident hologram to seal packs of Zantac in 1989, many major drug companies have used holograms on at least some of their medicines in selected markets, employed as labels, seals, hot stamped patches, and blister foils.
Holograms provide counterfeiting protection through continuous innovation, invention, and evolution in techniques have created increasingly complex devices that are easily recognized yet difficult to copy accurately.
The evolving role of the hologram has also been accompanied by the increased use of the security device in combination with other authentication technologies. In such solutions, holograms often provide overt first-line authentication while covert features such as scrambled images, micro text, UV-sensitive or other special inks offer second-line authentication for trained examiners equipped with appropriate decoding equipment.
Authentication and traceability
Another trend has seen the serialization of holograms as part of systems that combine authentication with traceability. So called '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 pharmaceuticals consignment has been, where it is now, and where it is heading has become a fundamental part of production and logistical operations at drug companies. That's particularly important where the ability to identify the source of products is becoming a mandatory requirement, as it is with the Food and Drug Administration's and with some state requirements for pedigree.
While Congress is considering making the use of security marking on some pharmaceutical products mandatory using "overt optically variable counterfeit-resistant technologies" to protect consumers from fakes, the hologram is already specified as the authentication feature on the world's only statutory pharmaceutical marking scheme - the Meditag program in Malaysia.
This initiative requires all registered medicines, OTC pharmaceuticals, and traditional medicines to carry a uniquely numbered label built around a hologram. The system is supervised by a central authority organization that controls the issue of tags, and trains inspectors to examine holograms through the distribution chain.
Since its introduction, this system has led to an 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.
More recently NAFDAC, the National Agency for Food & Drug Administration and Control in Nigeria, has also announced that it is planning to introduce uniquely numbered holographic labels to be used on all licensed medicines distributed in the country.
Counterfeiting holograms
The success and near ubiquitous use of holograms in anti-counterfeiting applications has led to attempts to copy or replicate them. However, the intrinsic features of holograms mean that the techniques and visual effects make it very difficult to copy a properly conceived and executed authentication hologram with 100-percent accuracy.
Although the product and packaging they protect may have been counterfeited, the lower-quality copy of the hologram has more often than not been the feature that has demonstrated that it is a counterfeit. In this way the hologram serves as an effective detection feature, when sophisticated criminals have the resources to reproduce packaging that is barely distinguishable from the genuine--the same cannot be said of the fake holograms.
As an example, the situation involving Artesunate, an anti-malarial treatment, is often quoted. It is reported that over half of the sales of this drug in Southeast Asia are fake, despite the blister pack that incorporates a hologram.
What can be seen here is that, despite the simple hologram that's been used 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, most buyers and users of Artesunate see a hologram and think this means the medicine is genuine.
Taking responsibility
The Artesunate case is a classic example of how not to manage a hologram authentication program on a brand of medicine. The hologram has not been redesigned since it was first introduced and insufficient attention was paid to the distribution, examination, and purchasing patterns in the region.
In contrast, there are many examples of how holograms continue to provide a successful and vital detection function in pharmaceutical anti-counterfeiting strategies. Beyond creating a properly designed secure hologram, pharmaceutical companies and organizations involved in anti-counterfeiting efforts also recognize that it should not be the sole responsibility of the consumer to examine a hologram to check that the product is genuine.
It must be the primary responsibility of manufacturers and the enforcement agencies to ensure that fake pharmaceuticals not enter the legitimate supply chain in the first place. This is why successful brand protection programs now involve formal examination and inspection systems at different stages in the distribution network.
--By Ed Dietrich, an American representative of the International Hologram Manufacturers Assn. and the director of Reconnaissance Intl., a global intelligence source on authentication. IHMA is made up of more than 80 of hologram companies. IHMA members are the leading producers and converters of holograms for banknote security, anti-counterfeiting, brand protection, packaging, graphics, and other global applications.
Since Glaxo first used a tamper-evident hologram to seal packs of Zantac in 1989, many major drug companies have used holograms on at least some of their medicines in selected markets, employed as labels, seals, hot stamped patches, and blister foils.
Holograms provide counterfeiting protection through continuous innovation, invention, and evolution in techniques have created increasingly complex devices that are easily recognized yet difficult to copy accurately.
The evolving role of the hologram has also been accompanied by the increased use of the security device in combination with other authentication technologies. In such solutions, holograms often provide overt first-line authentication while covert features such as scrambled images, micro text, UV-sensitive or other special inks offer second-line authentication for trained examiners equipped with appropriate decoding equipment.
Authentication and traceability
Another trend has seen the serialization of holograms as part of systems that combine authentication with traceability. So called '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 pharmaceuticals consignment has been, where it is now, and where it is heading has become a fundamental part of production and logistical operations at drug companies. That's particularly important where the ability to identify the source of products is becoming a mandatory requirement, as it is with the Food and Drug Administration's and with some state requirements for pedigree.
While Congress is considering making the use of security marking on some pharmaceutical products mandatory using "overt optically variable counterfeit-resistant technologies" to protect consumers from fakes, the hologram is already specified as the authentication feature on the world's only statutory pharmaceutical marking scheme - the Meditag program in Malaysia.
This initiative requires all registered medicines, OTC pharmaceuticals, and traditional medicines to carry a uniquely numbered label built around a hologram. The system is supervised by a central authority organization that controls the issue of tags, and trains inspectors to examine holograms through the distribution chain.
Since its introduction, this system has led to an 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.
More recently NAFDAC, the National Agency for Food & Drug Administration and Control in Nigeria, has also announced that it is planning to introduce uniquely numbered holographic labels to be used on all licensed medicines distributed in the country.
Counterfeiting holograms
The success and near ubiquitous use of holograms in anti-counterfeiting applications has led to attempts to copy or replicate them. However, the intrinsic features of holograms mean that the techniques and visual effects make it very difficult to copy a properly conceived and executed authentication hologram with 100-percent accuracy.
Although the product and packaging they protect may have been counterfeited, the lower-quality copy of the hologram has more often than not been the feature that has demonstrated that it is a counterfeit. In this way the hologram serves as an effective detection feature, when sophisticated criminals have the resources to reproduce packaging that is barely distinguishable from the genuine--the same cannot be said of the fake holograms.
As an example, the situation involving Artesunate, an anti-malarial treatment, is often quoted. It is reported that over half of the sales of this drug in Southeast Asia are fake, despite the blister pack that incorporates a hologram.
What can be seen here is that, despite the simple hologram that's been used 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, most buyers and users of Artesunate see a hologram and think this means the medicine is genuine.
Taking responsibility
The Artesunate case is a classic example of how not to manage a hologram authentication program on a brand of medicine. The hologram has not been redesigned since it was first introduced and insufficient attention was paid to the distribution, examination, and purchasing patterns in the region.
In contrast, there are many examples of how holograms continue to provide a successful and vital detection function in pharmaceutical anti-counterfeiting strategies. Beyond creating a properly designed secure hologram, pharmaceutical companies and organizations involved in anti-counterfeiting efforts also recognize that it should not be the sole responsibility of the consumer to examine a hologram to check that the product is genuine.
It must be the primary responsibility of manufacturers and the enforcement agencies to ensure that fake pharmaceuticals not enter the legitimate supply chain in the first place. This is why successful brand protection programs now involve formal examination and inspection systems at different stages in the distribution network.
--By Ed Dietrich, an American representative of the International Hologram Manufacturers Assn. and the director of Reconnaissance Intl., a global intelligence source on authentication. IHMA is made up of more than 80 of hologram companies. IHMA members are the leading producers and converters of holograms for banknote security, anti-counterfeiting, brand protection, packaging, graphics, and other global applications.
