Drug-authentication strategies
PharmTech: Counterfeit goods are a concern not only in terms of revenue loss, but also in the misdirection of consumers believing they
are taking a drug that may or may not be effective or even potentially harmful. What types of technologies and strategies
can a pharmaceutical company use to authenticate its drug product to the consumer?
Johnson: Pfizer has a broad range of technologies that it uses to authenticate drug products with the consumer, such as color-shifting
inks, radio frequency identification, and 2D barcodes. These examples are primarily overt technologies, meaning they are typically
adapted to the end user that will be performing the authentication. Track-and-trace initiatives around the world are driving
the need for standardization of technologies, and the use of 2D barcodes for authentication is becoming the technology of
choice.
Pfizer's perspective
PharmTech: Are there specific approaches in place at Pfizer that you would like to discuss in terms of drug-product authentication
or other anticounterfeiting approaches? Can you provide best practices or examples of specific programs in place at Pfizer
to achieve supply-chain security?
Johnson: Pfizer typically has used a risk-based approach for determining the authentication needs for our drug products. In other
words, we address the need for anticounterfeiting and authentication measures on an individual product basis and based on
the market/regions where the product is sold. We are implementing a life-cycle approach to help us formalize the process for
choosing when and what to use and also when to discontinue use over the life cycle of the products.
I think the key to Pfizer's approach to supply-chain security was the development of a "One Pfizer" strategy across the company.
We recognized that the threats were increasing, our business was rapidly changing, and we could improve our collaboration/alignment
across the different functional groups involved in protecting our supply chains. We defined the supply chain as starting with
raw materials that we use in our products until the finished product is delivered to our patients. We are focusing on strengthening
processes across the supply chain.
To provide leadership and governance, we created a supply-chain security function and a standing cross-functional team. Some
of the functional groups represented on this team include quality, global security, procurement, commercial trade, global
logistics and supply, external supply, packaging technology, and public affairs.
Read more from Johnson about supply chain security
References
1. FDA, "Pathway to Global Product Safety and Quality" Report (Rockville, MD, July 7, 2011).
2. EC Directive 2011/62/EU, Directive on Falsified Medicinal Products (Brussels, June 2011).
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