EU requirements for protecting medicines against counterfeiting will become mandatory in February 2019. Consequently, pharmaceutical manufacturers are preparing to meet these demands with 2D identification codes and sealing of their sales packs. However, they should be aware that this measure alone will not guarantee a product’s integrity or authenticity. Only the combination with additional counterfeit-proof authenticity features can offer a comprehensive approach against fraud, misuse and tampering. Customized multi-level security concepts, including analog as well as digital features like NFC (Near Field Communication) ensure that all stakeholders, if informed expert or end user, can be involved in the authentication process.
Enhancing supply chain security
By means of EU Directive 2011/62/EC, the so-called Falsified Medicine Directive (FMD), legislators and pharmaceutical manufacturers intend to safeguard the supply chain in Europe. Effective February 9, 2019, every manufacturer must provide most of the prescription medicine packs (exceptions on white list) and a selection of high risk non-prescription packs (on black list) with an individual serial number in the form of a 2D code (DataMatrix) and a tamper protection feature. Thus, patients shall be protected against falsified medicines. As the requirements set out in the valid version have been known since October 2, 2015, the roadmap for those who need to take action is clear. The level of the counterfeiting risk determines whether or not a medicine has to be provided with these security features.
The Drug Supply Chain Security Act (DSCSA) mandates the development and implementation of standards for drug product tracing, to be phased in by 2023. A tamper-verification feature is not part of the DSCSA. In terms of physical packaging, the FMD and the DSCSA do differ in many details besides this. Since the demanded safety features were released, it seems that tamper-verification measures in general gained attention with respect to the value they provide to secure a product´s integrity and the manufacturer’s brand.
Serialization plus authenticity
Serialization by means of 2D codes, as required by the EU Directive, opens up additional opportunities to the industry. It controls internal logistics processes more efficiently and offers clear identification of every individual medicine pack. However, further actions are necessary to convert an easy-to-copy serialization code into an authenticity feature for effective verification. Deep industry knowledge combined with specialized know-how in materials and printing technologies are prerequisites for developing tamper protection and anti-counterfeiting solutions for the pharmaceutical industry.
Effective security solutions for diverse threat scenarios can be divided into three categories:
- A label may clearly indicate first-opening and tampering.
- Integrated technologies of various security and detection levels provide effective protection against counterfeiting.
- Track & trace system solutions serve to identify and trace products, and thus indicate gray market activities.
All functional components can be customized and combined with each other. This results in complex security labels that effectively put a stop to the counterfeiters’ game and offer a wide range of added value to the pharmaceutical company.
Human Visible, Overt Features
Overt features enable fast authentication by sellers, pharmacists and consumers without any extra tools. Optically variable holograms, for instance, are based on microscopically small, diffractive structures in the film layers, which make the feature unique and thus achieve a high level of counterfeiting protection. Pharmaceutical manufacturers increasingly complement this feature by security color-shifting inks. Providers of professional solutions rely on specialty inks that may only be used by security printing companies. Manufacturers achieve a particularly high protection level by combining these color effects with special printing techniques, “latent images” or thermo-reactive inks.
Machine Visible, Covert Features
Ideally, holistic counterfeiting protection should always consist of a combination of overt security features with digital and covert technologies.
Covert features are especially important for checking suspect products, for complaints and final legal proof. For this purpose, manufacturers integrate special molecules and pigments into the packaging or label. Only a special detector can prove the presence of these pigments during authentication. These robust and colorless markers can be invisibly incorporated into any design and implemented using diverse techniques. A customized formulation with an invisible “fingerprint” represents the highest level of counterfeiting protection, as it can neither be seen, copied nor re-engineered.
Digital security features use computer-generated and highly encrypted encodings as human-readable numbers, 2D codes or special random patterns to enable internet-based authentication in the pharmaceutical supply chain all the way to the end user. In addition, digital technologies offer direct interaction between the product and the person performing the check, and can thus serve to provide information and to support promotional activities.
However, due to the possibility of copying them, numbers and encodings alone are not counterfeit-proof. Companies should therefore always combine them with additional features. Copy protection patterns, for instance, provide clear proof of authenticity with a high-resolution, cloud-like printed image.
Smart E-Labels: Digital Authentication Made Easy
In the context of digital security features, there is another innovative technology that can help monitor the pharmaceutical supply chain and – just as importantly –enhance patient safety. Labels with integrated Near-Field Communication (NFC) technology that allow digital data to be read out contactless using a smartphone. Due to their thin and flexible structure, the labels with integrated NFC chips can be easily applied to primary containers during production and open up a wide range of applications for pharmaceutical companies, such as counterfeiting protection, interaction with patients and lock-and-key applications.
The solutions using an e-label as protection against counterfeiting attempts are as varied as the threat scenarios — they range from online, offline verification, password protection and signatures to encryption techniques. Manufacturers benefit from the widespread use of NFC-enabled smartphones, in which corresponding readers are already integrated to read the data. Up to now, the use of NFC readers was primarily limited to the Android operating system, but recently Apple’s iOS has been provided with NFC label reading capability as well. Thus, every stakeholder involved in the process is able to perform reliable and easy authentication. In addition, data can be fed back to the pharmaceutical manufacturer during authentication. This provides the manufacturer with important information, for instance, to monitor the supply chain and to clarify possible gray market activities.
In addition to authentication, the patient can obtain further information and assistance when using these e-labels. The data can either be stored directly on the NFC chip or retrieved via the internet. Thus, the patient as well as healthcare professionals, for instance, gain easy and interactive access to important information about their medicine, such as clear identification of the medication, its expiration date as well as product or warning messages. Furthermore, a respective NFC label can assist with difficult handling by enabling the manufacturer to store explanatory videos or audio files showing how to correctly use the product.
However, the possible uses of NFC labels are not limited to smartphone-based authentication by the user. A medicine marked with an NFC label can also interact with respective medical devices in the sense of lock-and-key applications. In the case of medicines, the medical device, such as an infusion pump, reads the data stored on the NFC chip. Initially, authenticity and shelf life of the medicine are checked and subsequently, the information transmitted by the chip assumes control of the device. Thus, administration of counterfeit or wrong medicines can be prevented and dosage errors avoided. In addition, the programming of the NFC chip in the label prevents reuse and thus misuse of the original container.
Qualification and implementation
The requirements of the EU Directive to enhance the security of medicine packs meet with proven technologies on the manufacturers’ side. An analysis of the threat scenario and the product to be protected, as well as the development of an appropriately adapted security strategy, provide an important basis for selecting the security technology best suited for the respective task. However, the subsequent qualification and implementation process should not be underestimated. In addition to the high complexity involved in the system integration of code printing, checking and acquisition, administration and transfer to a database, solution providers have to rely on established know-how of integrating anti-counterfeiting and tamper protection. The experts not only consider the technical requirements and the particularly high quality criteria of the pharmaceutical industry, but also the demands made on security manufacturing, warehousing and distribution. Tamper protection and anti-counterfeiting measures are tasks requiring comprehensive, in-depth security management. Thus, effective measures to protect products against counterfeiting should always be based on a holistic approach to product and patient safety.
ABOUT THE AUTHORS
Nadine Lampka is Product Manager Pharma-Security at Schreiner MediPharm, a business unit of Schreiner Group based in Oberschleissheim near Munich in Germany. Schreiner MediPharm develops and produces innovative, multi-functional specialty labels with value-added benefits for the pharmaceutical industry. Nadine is in charge of defining business development strategies as well as managing the product portfolio which covers complete security systems.
Arne Rehm is Product Manager RFID/NFC Solutions at Schreiner MediPharm. He is in charge of developing new markets and smart solutions for diverse applications in pharmaceuticals and medical devices.