This past July, Pfizer and FDA made a distressing announcement: Counterfeit Viagra (silendafil) had been discovered in California
retail pharmacies. The fakes weren't perfect. The tablets were sharper-edged than the real thing, and the distinctive blue
was a bit off; the trained eye could spot typographical glitches on the packaging. But perfect or not, they were apparently
good enough: More than a year after the notorious counterfeiting attacks on Lipitor (atorvastatin) and Procrit (epoetin alpha),
and the establishment of an FDA task force to fight counterfeiting, a prescription drug supply system that was already on
the alert had again been penetrated. (See "Counterfeits: The Cost of Combat," Pharm Exec, November 2003.)
Safe+Secure Pharmaceutical Supply Chain
The sobering incident came on the heels of an interrelated set of developments that in their own way threatened the security
of the drug supply chain:
- congressional action to open US borders to drugs from other countries
- an explosion of internet pharmacy purchases
- Interpol warnings about terrorist involvement in counterfeiting
- an increasing number of offshore manufacturing facilities, making the supply chain longer and more vulnerable.
Alone, these issues would be worrisome. Together they make it clear that pharma desperately needs a way to control the integrity
of its products.
The good news is that highly effective technology for tracking and accounting for medicines is near at hand, in the form of
an electronic product code (EPC) information management system, using radio frequency identification (RFID) technology. In
essence, an EPC can give a unique individual numerical identity to every single unit of medicine—a process called mass serialization.
RFID, meanwhile, automates the reading and tracking of these numbers and adds a layer of technological security. Fully implemented,
an EPC/RFID pedigree system should enable authorized users to automatically identify and account for each unit of authentic
medicine in real time as it enters and moves through the distribution system. It could identify the current location of all
suspect products in the event of a recall, track disposal of damaged and out-of-date product, and allow law enforcement full
and accurate supply chain visibility if terrorists were to launch an attack using tainted medicine. And it should do all this
with minimal increases in staffing and packaging costs.
The US drug system has embraced EPC/RFID and is betting most of its "anticounterfeiting chips" on the expectation that a fully
implemented system will be in place and operating (at the unit packaging level) by the year 2007 or earlier. The state of
Florida already requires pedigrees for some products. Today's compliance challenge will grow exponentially when the Florida
law expands to all drugs and all wholesalers in July 2006.
This article explores some of the hurdles and questions that currently exist. It also identifies key steps that must be taken
to move forward and examines approaches that might be useful if full implementation cannot be achieved in this time frame.
Whats the Timeline?
An Internet of Things
RFID is not new. During World War II the Allies used it to help fighter pilots distinguish their planes from enemy aircraft.
The systems used then were expensive and bulky. Today's RFID chips are about the size of the period at the end of this sentence
and may ultimately cost just a few cents to make and apply.
The revolution in the size and cost of chips has been married with, and stimulated by, a consortium of businesses and academic
institutions. In 1999, the Uniform Code Council (UCC), several leading international companies, and the Massachusetts Institute
of Technology formed the MIT Auto-ID Center, under the leadership of Kevin Ashton and Sanjay Sarma. The center was founded
on a vision of an "internet of things," in which all products would be tagged with inexpensive chips that linked them to the
global business information infrastructure.