Don’t mess with me - tampering in the pharma industry

Faubel looks at tampering issues in the pharmaceutical sector

The online trade in medicines that are illicit are hazardous to health has been rising continuously. This is also confirmed by the results of the Interpol-coordinated operation Pangea. While 9.8 million illicit and counterfeit drugs were seized in 2013, their number has climbed to 20.7 million in 2015. There is a pressing need for pharmaceutical manufacturers and international institutions to take action.

EU directive provides standards

In mid-2011 the Council of the European Union adopted Directive 2011/62/ EU requiring that safety features be integrated into the outer packaging of prescription drugs and provide evidence of tampering, amongst other things. Counterfeiters tend to use the original packaging and replace the medicine inside by a fake replica. Such activities pose a significant health risk to consumers. Pharmaceutical manufacturers and distributors are facing financial losses, huge brand damage and a loss of confidence on the consumers' part.

Security seals, labels and tapes

Security seals, labels and tapes are one means of protecting the integrity of the packaging. When selecting a suitable sealing label, first consider the type of packaging to be protected. So-called fibre-breakage labels are a popular option. These labels are coated with a high-performance adhesive that bonds consistently with the cardboard packaging. When trying to detach the label, individual fibers will come off the substrate and the folding box will be irreversibly damaged.

Labels made of shrinkable materials are remarkably effective when it comes to protecting bottles, vials, pens, syringes and dose containers against tampering. Subjected to heat shrinking, labels will wrap tightly around containers of any shape so that custom shapes can also be protected.

Highly informative

Seals can be enhanced with additional functions and converted into thick booklet labels featuring many pages. To do so, it is necessary to widen the gutter or the closing part of the booklet label and enhance it with security perforations or special materials. The combination of tamper-evident closure and labeling provides enough space to accommodate legally required information in many different languages. Moreover, label sections can be peeled off the seal and stuck into a patient record for documentation purposes. Integrated scratch-off fields where identification numbers and codes are covert is another possible option. Authentication features such as guilloche, temperature-sensitive and UV-sensitive inks as well as specialty materials with hidden markers can also complement the design of sealing labels.

Changes in temperature and void seals

If counterfeiters are skilful enough, a sophisticated seal will often not be sufficient to protect drug packaging against tampering. When they encounter self-adhesive labels or cartons sealed with hot-melt adhesive, counterfeiters may attempt to melt the glue by heating it. If it succeeds, the package can be opened and resealed without notice of initial opening. This technique and other similar ones can be averted by using adhesives that perform well at service temperature but also in other temperature ranges. Ultimately, the use of temperature-sensitive inks is bound to reveal changes in temperature.

Another group of seals are the so-called VOID seals. When peeling the label off the package, there is a "void effect" which results from the combination of color, ink and adhesive layers protected by transparent cover film.

Effective solution

The more time-consuming and difficult the removal of a sealing label is, the less attractive it is for counterfeiters to use the original packaging for their fake products. Thanks to this effective solution, consumers' risk therefore becomes lower and that of pharmaceutical manufacturers, too.