New strategies to combat dangerous product piracy in the pharmaceutical sector
Binding directives from 2019
In compliance with the EU Regulation 2016/161 adopted one year ago the provisions for protection against drug counterfeits are due for implementation from 9 February 2019. Even today, pharmaceutical companies, packaging producers and service producers are developing internationally acknowledged solutions to ensure the highest patient safety possible. This is the only way to guarantee that the manufacturing, IT and logistics processes are changed in line with the directive within the set period and that each individual medication can be traced precisely along the supply chain. The affected parties are to be protected by this while stopping illegal trade at the same time. By WHO accounts, over 10 per cent of all drugs sold must be rated as counterfeits.
One company presenting novel approaches to tamper-protection is Schreiner MediPharm: a safety label equipped with digital properties and built-in first-opening seal informs the user instantly whether the drug is genuine. The booklet attached to the packaging contains a fastener with a so-called Void Effect: After opening for the first time, a graphic invisible before is irreversibly revealed. And thanks to the booklet you can also see the contents of the packaging without having to open it. This means the tamper protection is retained. On top of this, three digital features make for extra safety:
BitSecure This innovative protection technology consists of high-resolution noise patterns that lose their focus and detail when copied. Any copies can therefore be immediately checked via smartphone App, scanner or a 2D-barcode reader in conjunction with the corresponding software. Due to the reduced size of the patterns BitSecure can easily be integrated into the manufacturer’s logo on the packaging.
KeySecure This modern tracing system allows swift identification of drugs by way of a code consisting of a sequence of 15 numbers and letters. Patients can enter the 2D code online or communicate it to a specially set up hotline to have their drugs checked for authenticity.
Digital Authentication Checks Here a NFC chip is integrated into the label. A special App allows users to check the authenticity via Smartphone contactless and in no time.
Booklet label with built-in anti-tamper seal by Schreiner MediPharm. Photo: Schreiner MediPharm
Tablet colour as an indication
US scientists at the University of Louisiana say they have found a way to detect counterfeits via the colour pigments contained in a drug. With a special device for measuring and comparing colour shades the previously saved reference data can be compared with the actual colour thereby obtaining information on the authenticity of the tablets. Due to the low costs associated with this process that dispenses with elaborate assemblies this control is particularly suitable for development and threshold countries, say the researchers. While this technology is already used for checking food quality criticism has been voiced in connection with drugs: possible contamination, colours that fade over time and the unavoidable opening of the packaging, they feel, do not permit 100% safety.
Specially developed control software serialises individual packaging units, checks codes and automatically rejects unfit units. Photo: Atlantic Zeiser
Looking to China we see that there has been an obligation to serialise drug packaging with an Electronic Drug Monitoring Code for little over one year now. The encoding system dubbed ‘China-Code’ is hoped to guarantee transparency and traceability along the supply chain. Existing packaging lines have to be re-fitted by exporting companies to live up to these international requirements. Specially developed control software serialises the individual units, checks the codes and automatically rejects any units unfit for use. This ensures audit-proof generation – despite high speed and large amounts of data. Four packaging units can be processed per second. The software can be flexibly adjusted to all legal provisions – also to the traceability of the E-Pedigree Applications required in the USA.
The integration of NFC technology (Near Field Communication) in drug labels is considered a forward-looking new development with high added value in the sector. Photo: Schreiner MediPharm
Smartphones with infrared sensors
And back again to the Middle Kingdom: here a smartphone was equipped with a mini IR spectrometer on its reverse. The in-built sensors are capable of determining molecular properties and chemical compositions. The wavelengths reflected by the IR light on the product are uploaded to a Cloud and analysed there on a database with the help of an App. If you place the telephone sensor next to a pill, the smartphone displays its verdict – true or false – based on the visible properties. Although not all test stages produced 100% correct results, this device is already used in China. From June 2017 it is said to be available on the US market, too.