Label supplier says Germany’s new counterfeit drug ‘shield’ not sufficiently effective

Pharmaceutical industry and pharmacists associations to start pilot project soon in Germany.

3S pharma blister
3S pharma blister

An international manufacturer of labeling systems for legally binding counterfeit protection notes that in January 2013, several German pharmaceutical industry and pharmacists associations will start a nationwide pilot project to assess the efficiency of a protection system against counterfeit drugs.

The securPharm initiative, launched by German pharmaceutical manufacturers, wholesalers, and pharmacists, is intended to comply with the European Union Directive on Preventing falsified medicines, published in July 2011. An English translation of how the security system works explains that pharmacies participating in the pilot “will be equipped with a data-matrix scanner that can be used to read the code.” Pharmacists scan a coded sales pack before dispensing it to the patient. That initiates a query into the database. “If the system serial number is accurate, the system confirms the query and the number is flagged as ‘dispensed’ in the database. However, an unknown serial number, or one that has already been flagged as ‘dispensed’ by prescription triggers an alarm. The patient is then given another, correct pack, and the reasons for the suspected counterfeit are investigated.”

On its Web site, The European Compliance Academy reported in 2011, “Because of the involvement in the securPharm initiative of all German Association of Pharmaceutical Manufactures as well as of The German Society of Hospital Pharmacists and the German Wholesaler Association, one may expect that securPharm will become the relevant standard for all pharma companies in Germany and possibly in other European countries too. The motto of the initiative is ‘end-to-end’ instead of ‘track and trace.’  In a track and trace context, data are read out in each supply phase of the medicinal product while in an ‘end-to-end" solution, verification, and data comparison should be performed in the pharmacy.”

Despite that promising forecast, anti-counterfeit technology maker 3S Simons Security Systems GmbH expressed doubt about securPharm in a Dec. 10, 2012 press release issued just ahead of the pilot launch.

The following details are from that press release, which included the image shown here of the company’s Secutag® counterfeit protection system:

“In anticipation of the test phase, 3S warns that the new system does not prevent counterfeit drugs from getting into the legal supply chain, linking pharmaceutical manufacturers and pharmacists.

According to current plans, the securPharm initiative relies solely on the data-matrix code to secure drug packaging. Even though the code provides new route and process tracking options, it is yet not counterfeit-proof. "Wrong data-matrix codes can easily be printed on packages of fake drugs using an ink-jet printer," says Rolf Simons, managing director of 3S Simons Security Systems GmbH. "In order to not harm the health and life of patients, securPharm should be combined with a real anti-forgery system. This is the only way to make sure that counterfeit drugs are not distributed to German pharmacies via the traditional pharma supply channels."

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