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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.

An example of a serialized pharmaceutical carton.
An example of a serialized pharmaceutical carton.

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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