GlaxoSmithKline (GSK) has begun distributing a medicine tagged with radio frequency identification (RFID) technology as part of a pilot project to help protect patient safety. Following is the text of the announcement from GSK:

The tags will be placed on all bottles of the anti-HIV medication fixed-dose combination Trizivir (abacavir/ zidovudine/ lamivudine) distributed in the United States. When scanned at close range, the tags will help verify that the medicine bottle contains authentic Trizivir. This specific medicine was selected for the project because it has been listed by the National Association of Boards of Pharmacy as one of 32 drugs most susceptible to counterfeiting and diversion.

The US Food and Drug Administration (FDA) has asked the pharmaceutical industry to develop standards and pilot processes for RFID that may lead in the next few years to broad adoption and use of the technology. 

RFID uses a tiny silicon chip and antenna about the size of a postage stamp that is attached to each bottle of medicine. The chip stores a unique product code that reflects information about the drug’s manufacturing and shipping history.  The product code can be read by pharmaceutical wholesalers and pharmacists using a hand-held or stationery electronic device that is placed within 2-18 inches of the tag.

The tag can be read by wholesalers when it is received from the manufacturer and when it is shipped to pharmacies, who would then record when they have received the medicine. This allows manufacturers to more precisely account for medicine as it moves through the distribution chain and to authenticate medicine at the point of dispensing.

The technology does not collect any patient information.  The RFID tag contains information about the product only, not the patient.  GlaxoSmithKline will not collect any personally identifiable information about patients through this technology.

“This is one more step toward safeguarding Americans’ supply of medicine,” said Mark Shaefer, vice president of the HIV and Infectious Disease Medicine Development Center at GlaxoSmithKline. “The hope is that RFID tags can tighten the supply chain even further to help assure patients that the medicine they buy is indeed the medicine their doctor has prescribed.”

A variety of other measures including packaging design have been taken by GSK and other manufacturers to discourage counterfeit medicines.

RFID tagged bottles of Trizivir will begin appearing on pharmacists’ shelves in mid-April.

As one of the first pharmaceutical companies to test RFID, GSK is working closely with the FDA to assess the technology and its prospects for reducing counterfeiting.  The project has cost several million dollars.

The testing of the RFID technology on additional products will be evaluated by GSK with guidance from the FDA as the Trizivir pilot progresses.

GSK has worked with IBM to design and build the technology in the pilot program, which allows GSK to tag each bottle with a unique product code. The tags themselves are not easily copied.

04/04/06

Source
GlaxoSmithKline. GlaxoSmithKline Begins Testing New Technology To Protect Patients against Counterfeit Medicine. Press Release. March 30, 2006.