Pharmaceutical Commerce - June 2018 - 18
F E AT U R E
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 NFCenabled 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
18 \ Visit our website at www.PharmaceuticalCommerce.com \ 06.2018
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
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 anticounterfeiting 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.