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Ensuring Patient Safety with RFID Solutions
By serializing products, we can implement recall processes that are more requirements on a national scale. One could argue that California, with
focused than current standards. If necessary, we can implement recall a gross domestic product larger than all but the top eight economies in
activities at the unit level, as opposed to batch level. Additionally, if the world, can essentially be thought of as a de facto country in its
ePedigrees are passed through the supply chain, we can manage the own right. Elsewhere in the US, Nevada and Virginia have smaller, less
recall process by contacting the known locations of our products. These extensive ePedigree requirements; Florida’s 2006 ePedigree legislation
stipulated that information has to be manually recorded only. The US
Food and Drug Administration (FDA) has a January 2010 deadline for the
creation of a system to protect the pharmaceutical supply chain from
It may be a number of years down the “counterfeit, diverted, subpotent, substandard, adulterated, misbranded
or expired drugs.”
1
However, this is not limited to electronic solutions;
line, but RFID technology will completely
nevertheless, with the potential for 50 different mandates from each of
revamp the way in which shipping of the states, the pharmaceutical trade could rapidly become very tricky if
no national legislation supersedes.
pharmaceutical goods is conducted.
Long-term Outlook
In the long run, tagging products at the unit level using RFID to create
capabilities will enable us to recall products more efficiently. Returns fully serialized ePedigrees will enable a reduction in much of the manual
processing can also become more effective with the use of RFID. By effort that is currently involved in the supply chain, including unit counts
capturing the EPC and referencing the data back to our ePedigree and and product review prior to shipping. With one scan, hundreds of tags
internal systems, we can verify the path of products. This will enable us for storeroom products can be read and correlated with the inventory.
to credit our customers more accurately and efficiently, with less manual The ability to check quickly and in realtime will stop shipment errors from
data entry. occurring and will help identify where differences occurred en route. It
may be a number of years down the line, but RFID technology will
Naturally, implementing RFID will generate significant amounts of data completely revamp the way in which shipping of pharmaceutical goods
that by themselves will be meaningless. The difference between ‘average’ is conducted. At Cephalon, our view has always been that 2D barcodes
and ‘successful’ implementation of RFID will be how these data are used. do not remove the requirement for line of sight when tracking products,
If they are interpreted and utilized, they will provide meaningful business and therefore while they provide serialization they will not bring any
information to help streamline operations and bring innovation to the great efficiency advances. One of the biggest benefits of RFID is that the
supply chain. This is one area where companies can turn their investment contents of a case of products can be read without opening the case.
into RFID in a valuable resource with potential new revenue streams.
Overall, RFID will increase efficiency in receiving and shipping and
Mandating Radiofrequency Identification managing inventories, potentially affecting the whole supply chain.
So far, the main US legislation concerning pharmaceutical RFID Currently, we receive electronic data interchange (EDI) inventory-level
implementation is California’s ePedigree mandate, which explicitly data from our wholesalers, but when this new environment is fully
requires serialization for all drug packages coming into the state,
covering the drug’s life from the point of manufacture to the point of
sale. While this can basically be achieved with a 2D or a Reduced Space
I believe that the whole supply
Symbologies (RSS) barcode, we believe that RFID is the future-proofed
alternative. The Californian requirements have been delayed several
chain will be online in five to 10 years.
times, with the implementation date currently scheduled for 2015. We
At that point we will have greater
have strived to comply with the requirements as they have evolved, and
we believe that we will be compliant when required.
visibility and less chance of counterfeit
drugs entering the market.
One benefit of working for a mid-sized company is that we have
approximately 20 products; some manufacturers have more than 3,000
stock-keeping units to deal with, which is an exponentially greater enabled, we hope to have access to an individual-unit-level visibility.
challenge. I think that many companies will take a phased approach to Ideally, we will reach data-sharing agreements with pharmacies to
ePedigree implementation, beginning with their high-value, most often provide us with visibility on stock levels down to individual bottles on the
diverted and most ‘dangerous’ drugs. shelves. I believe that the whole supply chain will be online in five to 10
years. At that point we will have greater visibility and less chance of
Nationally, there is discussion related to serialization standards and the counterfeit drugs entering the market. It all adds up to a combination
potential federal legislation related to ensuring a safe and secure drug of greater efficiencies and more secure drug chain—and that will
supply chain. At this time, it is too early to speculate on the future translate into huge benefits for the patient. n
1. www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2009-D-0001-gdl.pdf (accessed April 29, 2009).
PHARMACEUTICAL SERIALIZATION & AUTHENTICATION
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