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Authentication
Chapter
11
What Is Authentication?
As discussed in the last chapter, authentication in the context of pharmaceutical security (and accepting the arguably vague and inaccurate use of
the term) means asking the question Is this product genuine or fake? It
is therefore a binary issue: in theory the answer is either Yes or No. This
is not the same question as Does this product have the correct packaging or even Does this product carry a valid code or serial number?
Coding and tracking systems can be excellent authentication methods, but
are only effective if they are secure. It is possible to authenticate a product
as genuine to a legal grade of proof (beyond reasonable doubt) without knowing its life history. We do this every day with banknotes, for
example. However, the converse is not true: it is not possible to prove a
products provenance and route through the supply chain without being
able to authenticate it as genuine. Thus authentication complements, and
is not replaced by, the tracking technologies discussed later.
For reasons of practicality, many of the methods by which we verify
genuine products involve proxy indicators of authenticity, such as secure
packaging and tracking codes. However, it is not fake drug packaging
that harms people. Only if the ingested, injected, inhaled, or implanted
product itself is genuine, and of the expected quality, is the patient safe
from harm due to fake or substandard medicine.
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WHAT IS AUTHENTICATION?
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DIGITAL
SENSORY
Figure 11.1. Digital Versus Sensory Authentication. Both types of authentication methods
may involve examination by eye or by automated means. Digital authentication requires
confirmation of the presence of a pre-assigned number (whether printed as text, applied
as a barcode or 2D code, or coded onto an RFID tag). Physical authentication identifies
characteristics which do not depend on numbers.
there may be little benefit, and indeed a false sense of security may be
damaging in the long term. The design, implementation, and maintenance
of an authentication strategy are often difficult, potentially costly both
internally and externally, and always time consuming. It is also increasingly an inevitable cost of doing business in the pharmaceutical industry,
not a choice. No sane CFO (Chief Financial Officer) would decide to
forego corporate liability insurance, or decline funds for the repair of broken fencing around their animal research facility. Authentication should
be seen as a must-have, not a nice-to-have, if we are ever to start reversing
the tide of counterfeit drugs.
TYPES OF AUTHENTICATION TECHNOLOGIES
There are a large number of security technologies that can be used for
authentication of pharmaceuticals and medical products. Some have
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WHAT IS AUTHENTICATION?
Technology
Overt
Covert
Design features
Special security substrates
Recognition of random patterns (innate or applied)
Adhesives and closures
Taggants and dyes
Microparticles and nanoparticles
Optically variable devices
Security inks
Coding and serialization
been specifically designed for the purpose, and some are adapted from
approaches that have been used successfully in other industries. For any
individual product security requirement, the choice of technology will
depend on a number of factors including price, security level, feasibility,
etc. The technologies most commonly used in pharmaceutical product
security can be broken down into broad categories (Figure 11.2).
These various technologies can be used at different levels of packaging
and in different circumstances. As discussed elsewhere, it is usually prudent to use more than one technology to give a layered defense against
counterfeiting.
The principle is illustrated by the pyramid of authentication
(Figure 11.3). The vertical dimension (not to scale) represents the number
of people involved in authenticating the product at various levels of
security features. Two main aspects of authentication become apparent.
First, the alertness to danger increases greatly if the public (and those
in the supply chain who come into customer contact, such as pharmacists)
are given simple security features that they can verify visually or with
very simple tools. This is simply a function of the number of pairs of
eyes availablethe public, by definition, is everywhere. The second and
conflicting factor is that (in general) the wider a security feature is disseminated, the more it is vulnerable to attack by counterfeiters. A mixture of
the technology types above is therefore prudent, to provide stakeholders at
all levels of the pyramid with different ways to authenticate the product.
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Figure 11.3. The Authentication Pyramid. Overt security features at the base of the pyramid
reach the general public and allow a large number of people to be involved in validation.
Forensic tools at the apex may only be known to a small group, increasing security
but preventing widespread routine monitoring. Most anti-counterfeiting features involve a
trade-off between ubiquity of awareness and degree of security.
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WHAT IS AUTHENTICATION?