On-dose authentication technology
Placing authentication technology directly on the dosage form allows drug manufacturers to identify counterfeit or substandard
drugs that have entered the supply chain. On-dose technology uses physical chemical identifiers (PCIDs) such as inks, pigments,
flavors, and molecular taggants containing unique properties. The US Food and Drug Administration released a draft guidance
for industry, Incorporation of Physical Chemical Identifiers into Solid Oral Dosage Form Drug Pro ducts for Anti-counterfeitingin July 2009. Pharmaceutical Technology discussed the use of PCIDs and the draft guidance with John D'Ottavio, quality and regulatory affairs manager for ARmark Authentication
Technologies (Glen Rock, PA), a provider of custom authentication systems to fight counterfeiting, and Dean Hart, executive
vice-president of NanoGuardian.
PharmTech: What are the challenges a manufacturer may face when implementing PCIDs in terms of cost, operation, or other issues?
D'Ottavio: The major challenges that we have seen are related to the control of knowledge regarding the use of a PCID (i.e., who within
the company should have knowledge of its use) and the breadth of scale to implement a PCID technology (i.e., on which products
and regional versus global use). ARmark sells and markets the covert micro-tag PCIDs as a specialty excipient, a decision
that has enabled us to avoid cost hurdles associated with licensing. In addition, adopting covert micro-tag technology does
not require any incremental capital expenditure because it is an additional excipient that is added during re-constitution
of the film coating. For these reasons, cost has not been a prohibitive factor in the acceptance of this technology.
PharmTech: What can a manufacturer do in advance to ease implementation?
D'Ottavio: Manufacturers of drug products can perform risk analyses to identify the products at greatest risk for counterfeiting to prioritize
the implementation of PCID technologies. Additionally, controlling the knowledge of the use of PCIDs is paramount for covert
security features, and therefore, internal communication, as well as external communication, should be limited to a "need-to-know"
PharmTech: Can you discuss the impact of the PCID draft guidance on industry's anticounterfeiting efforts?
Hart: It is obvious that FDA sees the importance of on-dose technologies in the fight against counterfeiting and illegal diversion.
Although FDA guidance is certainly needed when manufacturers are adding any type of chemical substance to a product, we are
hopeful that the final FDA guidance will not be relegated to PCIDs only, but rather expanded to include more advanced on-dose
technologies such as forensic markers, which add nothing to the dose yet provide equal, if not more comprehensive, protection
against counterfeiting and illegal diversion given its layered security.
PharmTech: How can the pharmaceutical industry protect itself and consumers from counterfeit drugs?
D'Ottavio: Protecting the dosage itself, which is ingested by the patient, should be a critical concern in the hierarchy of counterfeit-resistant
technologies. Protection must start with the identification and authentication of the dosage form because the distribution
process for drugs involves repackaging, which is a vulnerable point for counterfeit product introduction.
Counterfeit-resistant technologies for protecting the package and supply chain will be far more effective when the dosage
itself is also protected with on-dosage identification and authentication technology.
Hart: Manufacturers must realize that the enemy in this war is highly motivated, connected, and resourced. Traditional methods of
brand protection, while still valuable, are waning in benefit. It is a new-age battle that requires manufacturers to fight
with everything at their disposal, including state-of-the art technologies that protect the integrity and therapeutic benefit
of each and every dose.