Track and Trace Regulations Mean New Technologies for Pharmaceutical Packaging

The market for counterfeit pharmaceuticals is booming – around 10 to 15 percent of medication worldwide are presumed to be illegal imitations. Many countries, among them Argentina, China, South Korea and the USA, have already added track and trace systems to their pharmaceutical packaging. In 2017, the world-wide costs for coding and serialising in the pharmaceutical industry amounted to around 800 million US dollars. According to forecasts by the research agency Future Markets Insights, this value is expected to increase to approx. 1.8 billion US dollars by 2024.

In North America, the market for counterfeit pharmaceutical packaging is particularly large, however, the most rapid growth until 2026 is forecasted for Latin America and Africa. According to the World Health Organization, developing countries face a particularly significant problem with regard to the penetration of markets with inferior or counterfeit medication; here, estimates place the value at a minimum of 30 percent. However, there are positive examples of countries successfully combating the illegal medication market.  Nigeria, for example, was able to reduce the circulation of illegal pharmaceutical packaging by 80 percent by limiting the import of medication to only two national points of entry.

In January 2019, Russia passed the law known as the Crypto-Code Act. This stipulates that all pharmaceutical products must be serialised according to a uniform national system. Besides a unique identification and serial number, packaging must contain a sequence of characters that is generated by cryptographically re-ordering the identification code. This is done for monitoring and verification purposes. To receive the fee-based crypto key and the necessary data transfer, so called “issue recorders” are connected to a Cloud. Re-fitting is expected to be easy and applicable to all packaging formats without further effort, even if they are particularly small and / or sophisticated. Packaging manufacturers now have one year to implement the new serialising system, which will be mandatory from 1 January 2020.

Due to the cryptographic transformation, the crypto code data set contains almost twice the amount of data compared to the corresponding GS1 data matrix codes used in the EU and USA. This renders international trade with pharmaceuticals made in Russia more difficult.

Since February 2019, packaging manufacturers of pharmaceutical products have been subject to even stricter guidelines within the EU. The new EU Falsified Medicines Directive intends to dam trade with falsified pharmaceutical packaging and improve patient protection.

After manufacturing, all data of prescription medication is transferred to a database that connects manufacturers, doctors and pharmacists. In addition, medication must have a 2D barcode as an individual identifying feature. Pharmacists are obliged to scan these barcodes every single time they issue medication. This control guarantees that packaging has neither been falsified nor stolen.

In addition, pharmaceutical packaging must be equipped with an individual, tamper-proof identifying feature for easy identification as well as tamper-proof seals. These seals, known as tamper evidence, can be provided by special devices such as cuffs, sleeves or seals, which prevent subsequent manipulation of the pharmaceutical packaging.

The Fraunhofer Institute for Secure Information Technology has integrated a total of eight different colours in their JAB barcode. This allows the barcode to store more data than a black and white code. Whilst the latter can often only refer users to websites for further information, the coloured codes can be read out on the spot.

In the wake of the new EU directive, the company Schreiner MediPharm and the Edelman Group have developed an intelligent packaging solution that includes digital functions using BitSecure copy detection technology.

The BitSecure copy detection technology is a printed, digital security feature. BitSecure is based on a high-resolution, random pattern whose delicate details are not discernible by the naked eye. In an attempt to copy the small random pattern with a size of just a few millimeters, the printed image will suffer a loss in precision and optical details. The pattern can be authenticated quickly and flexibly on-site using a smartphone or handheld reader, and analyzed via related software. BitSecure is a reliable yet cost-efficient authentication technology. Due to its small size, it can be easily integrated into existing packaging or label designs.

It is also possible to integrate interactive patient information. The seal can also be integrated into conventional packaging and label designs.

With their Serial Pharma software, Macsa ID in Great Britain have brought to market one of the first certified solutions for reading data matrix codes and monitoring alphanumeric numbers in accordance with the new EU directive. With the aid of this marking equipment, users can manage packaging orders, generate serial numbers and encode various formats for reporting and monitoring. The high-resolution ink jet technology is suitable for labelling blister packs, tablet packages, cardboard boxes and palettes.