Security of Drug Anti-Counterfeiting Measure Questioned

Dec. 12, 2012
Data Matrix Code not sufficient, some say.

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. In anticipation of the test phase, 3S Simons Security Systems GmbH is warning that the new system, Securpharm, 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 not yet counterfeit-proof, according to Rolf Simons, managing director of 3S Simons Security Systems GmbH, a manufacturer of labeling systems for counterfeit protection.

“Wrong data matrix codes can easily be printed on packages of fake drugs using an ink-jet printer,” he said. “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.”

To combat falsified medicine moving through international supply chains, the EU Parliament adopted a pharma directive on counterfeit medicine in 2011. This directive states that packaging of medicinal products has to be marked with a safety feature to be able to verify the authenticity of the medicinal product and single packages. Pharmaceutical manufacturers, pharmaceutical wholesalers and pharmacists are developing the security system Securpharm, which is going to be tested in a pilot project in January 2013. The EU member states have to provide the EU Commission with details on their specific national systems by July 2013. In this context, Securpharm could be used as a reference model.

The concern is that counterfeit data matrix codes could be printed on packages of fake drugs using an ink-jet printer and that pharmacists would not be able to identify these counterfeit drugs in case the serial number has not yet been queried in the database or has been entered as sold. They could then sell the fake product to the patient. The system would reject the original in a subsequent query and would identify it as a counterfeit drug because the product status has been set to “sold.”

One approach to combat this is the use of micro color codes that could protect both drug packaging and data matrix codes. The color code would be stored to Securpharm's database of manufacturers or pharmacists and enable tracking a drug's production and supply chain travel, from the manufacturer to the pharmacist. Each manufacturer would be provided with an individual color code, ensuring unambiguous allocation of the different drugs.

First, the data matrix code is read during the verification process. Then, the micro color code is checked for conformance, proving the authenticity of the drug and the data matrix code.