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Taking a Multi-Layered Approach to Pharmaceutical Counterfeits

Tamper-verification, security features, serialization, and track-and-trace measures can help pharmaceutical manufacturers ensure their products are authentic.

According to estimates released by the U.S. FDA, one in 10 pharmaceutical drugs are counterfeited. While this translates to an estimated 1% penetration rate in developed countries in Europe and North America, the figure can reach up to 30% within Africa and the Far East. Alarmingly, according to the World Health Organization (WHO), in 2011 64% of all antimalarial drugs in Nigeria were counterfeit.

Packaging and authentication manufacturers advocate applying multiple measures to provide enhanced security, including tamper-verification solutions, security features, and pre-serialization measures. Tamper-verification solutions are vital as they instantly allow the consumer to identify if the drug they are going to consume has been previously opened or interfered with, providing a first layer of security. Such products could take the form of a label that leaves a void message or a carton that is glued closed.

There are three types of labels that Essentra, a global provider of specialist packaging and authentication, recommends as a part of an expanded portfolio fiber tear labels, void release labels and frangible film labels.

Fiber tear labels provide a clear visual indicator that the pack has been opened, as they irreversibly damage both the print and carton board to which the labels are affixed. When the labels are removed, a ripped appearance remains, even on varnished coatings.

Similarly, void release labels provide a clear visual cue that is more aesthetically pleasing than the former, leaving behind a void message or specifically designed pattern on the carton. On a more sophisticated level, frangible film labels use a specially engineered substrate that disintegrates the label when consumers attempt to remove it from the carton board.

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